Hi Tem, I dont know that we are that far off from each other, but:
1) An imbalance in TIPS after randomization is concerning because that is likely what drove the mortality difference. We dont know that the difference was driven by transfusion strategy, although that is a hypothesis that should be tested. Changing your trial outcome halfway through absolutely is a critical critique, because the design of atrial (recruitment, operations, power, analytic plan) are driven by a scientific question that has a pre-specified outcome. Im not completely dismissing the Villanueva trial, but to suggest that it doesn't leave open questions would be a curious stance.
2. Restrictive transfusion does not save lives (whether in GI bleeding or otherwise). The trials showed NO DIFFERENCE in mortality. This was one of my first points in the blog post. So may clinical story was not anecdotal, but pointing out that clinicians, based on trial data, should feel comfortable that transfusing some with a Hb above 7g/dL and a 5g/dL Hb drop will NOT INCREASE THEIR MORTALITY.
3. Your logic would suggest anemia should never be treated, and the assertion that there is no benefit is not backed up by robust trial data. Trials are needed in outcomes other than mortality. They are out there, but patient-reported outcomes are very difficult to study and the trials have many methodologic issues. Transfusion has risks, yes this is true. The overwhelming majority of physicians vastly overestimate transfusion risk (for all transfusion reactions). We have data on this that we plan to publish.
4. I completely agree. People and funding agencies have to see the need for trials to answer these questions, but they dont when the incorrectly assume that restrictive transfusion saves lives and/or they overestimate the risk of transfusion.
Hi Micah, We're going to have to agree to disagree. There's no question that restrictive transfusion saves lives. It's not true in every context, but it is definitely the case for UGIB and almost certainly for the TRICC population as well. It's right there in black and white on pp. 18 -19 of the Villanueva trial (overall mortality OR=0.55, P=0.02) and p. 414 of the TRICC trial. People can look at the trials and decide for themselves.
Hard to know where to begin with your interpretation of the TIPS data. You have it totally backwards. Restrictive transfusion reduces portal pressures (p. 15), thereby reducing hepatic congestion and the need for TIPS. This is an *advantage* of restrictive transfusion that may have also contributed to the mortality benefit seen with the restrictive strategy. Again, I encourage people to read the trial for themselves.
It's been a nice conversation, but I think you have a lot to learn about how to read the transfusion literature before you can make broad (and baldly inaccurate) statements attacking it.
Hi Tem, Your last comment/sentence is unnecessary, patronizing, not collegial, and mean. It is also not indicative of someone willing to engage in an open honest debate. Your anonymous, I am not. For these reasons, I do agree to disagree.
Has anyone stopped to think about how our entire Red Cross blood bank should be considered contaminated with harmful vaccine spike protein? They do not even ask donors if they are vaccinated or not with the experimental gene therapies. This was a HUGE concern to my family as our infant granddaughter was hospitalized with iron deficiency anemia and a HGB of 5.2. They wanted to transfuse her at the children's hospital and when we requested unvaccinated blood only we were told that was not available. She ended up getting iv iron instead (thank God) but we found out directed donation to her by unvaccinated family members would take a week. It is completely irresponsible to NOT request vaccination status at the time of blood donation given we have no clue the long term side effects and the short term AE's are mounting up daily. Absolute INSANITY has happened to our healthcare system in the last 3 years.
Career hematologist and blood banker here. Love that there is attention being paid to the transfusion medicine literature, but Micah is fundamentally wrong here. He significantly understates the strength of the data for restrictive transfusion approaches. There are literally a dozen high-profile RCTs in different patient populations, and every single one shows the same thing--a restrictive transfusion strategy is noninferior and possibly superior to a liberal strategy. Even the example of "harm" Micah provides of GI bleeding has been directly studied in a well-designed RCT (Villanueva, et al. NEJM 2013). In those patients (non-exanguinating UGIB), a restrictive strategy appeared likely superior. The authors also did a beautiful physiologic correlate showing increased portal pressures in patients receiving more blood, which may explain (at least in part) the inferior outcomes in liberally transfused patients.
The call for a "usual care" control group also misunderstands the objective of these RCTs. When TRICC, etc. were designed, the key was to achieve significant separation in how the two arms were managed. A usual care group posed the danger of insufficient differentiation between the two arms (i.e. fairly similar volumes of RBCs transfused). Micah acknowledges this problem but seemingly fails to make the connection. Only by enforcing different strategies can this issue be avoided. Interestingly, the problem of inter-group separation has been a perennial concern in the transfusion literature (see, for example, the PROPPR trial).
Mortality was chosen as the outcome because mortality prevention is the central objective of transfusion. For example, in the TRICC trial all patients were in the ICU. Few would argue that "symptomatic anemia" is a concern for an intubated and sedated patient. Additionally, it's well understood now that the mere existence of anemia doesn't explain symptoms--and that anemia is often just a marker of the causative underlying process, which is often inflammatory (see PNH, for example, where high-quality data show transfusion does nothing to improve symptoms whereas complement inhibition does).
It is also inaccurate to say that randomized trial results were "biased" in favor of restrictive transfusion because they did not collect data on symptoms of anemia. The trials also prominently failed to collect data on the harm of over-transfusing patients, e.g. FNHTR, alloimmunization, allergic reactions, TACO, etc. These problems are often minimized or simply not understood by physicians who favor giving more blood more often.
It is a major overreach to claim that the transfusion thresholds literature represents an impending "medical reversal." In fact, it's the opposite--these well-designed RCTs reversed the prior belief, based only on bioplausibility, that "more blood is better." I could go on, but the bottom line is that countless patients have benefitted from the body of work that Micah assails.
1) I acknowledged and cited all the RCT's and meta-analyses (I am on guidelines committee, so I have spent EXTENSIVE time reviewing the data from every single trial).
2) The Villanueva trial has an imbalance in the number of TIPS between restrictive and liberal strategies. Thats a problem for obvious reasons. Also, I recently learned from Jeff Carson that the Villanueva trial changed their outcomes half way through the trial. This is also problematic for obvious reasons. Last, I dont know many good clinicians (even those aware of the Villanueva trial) who would feel comfortable not transfusing a GI bleeding patient whose Hb yesterday was 12.5g/dL but is now 7.1g/dL. So the broader point was the dogmatic application of trial data doesn't often serve patients.
3) I am not sure I understand your point about separation of trial arms, and we may be in agreement. Please read the two citations I provided on practice misalignment to understand why TRICC needed a usual care group.
4) Yes, anemia may be a marker of problems. Does that mean you dont think we should conduct studies to determine how to best treat it? Do you think a restrictive transfusion strategy is optimal for all patients and all anemia etiologies. Is mortality the only thing that matters? These were the points I was trying to raise.
Thanks for your response. To clarify at the outset: of course I’m not advocating a cookie cutter approach to all patients, and we need to use our clinical judgement to make decisions specific to each case. That said, in the vast majority of patients liberal transfusion is pointless and probably even harmful.
1. I’m confused by your point about TIPS in the Villanueva trial. You’re aware that the “imbalance” in TIPS occurred *after* randomization, right? It’s reported as an outcome in Table 3. This means that an additional advantage of restrictive transfusion is reducing the need for TIPS. I hope we can agree that this reflects a benefit, not a disadvantage, to restrictive transfusion. Regarding the study outcomes, I’m not sure how Jeff would know that they were changed, but even if true it does not on its own constitute a substantive critique of the paper. Restrictive arm patients also had lower overall mortality (by a lot, OR=0.55 and P=0.02), an outcome that is highly relevant regardless. As to your last point that “it’s not what I’ve seen good clinicians do,” this kind of anecdotal thinking is precisely the opposite of what we’re trying to achieve in evidence-based medicine. At my institution, we routinely keep UGIB patients at a Hgb goal of >7 g/L. RCT-level data shows that this practice saves lives.
2. Separation means that a large enough difference in transfused product between the arms is required for a meaningful comparison to occur. With a “usual care” group, there’s no guarantee this will happen.
3. Just to reiterate: 1) anemia is not the cause of symptoms in the vast majority of anemic inpatients, most of whom have other underlying disorders that predominate, 2) it follows that correction of anemia through transfusion provides little/no benefit while incurring risk (as has been shown repeatedly), and 3) the significant potential downsides of transfusion were not adequately considered, if at all, in your piece.
4. It would be huge contribution if you could identify specific patient population(s) that actually benefit from more blood. I genuinely mean that and would be open to changing my mind if high quality data were available.
There's also the wide practice among cardiologists of recommending transfusion above 8 in patients with CAD.
There's also the one in a million case of a floridly overloaded patient, no CHF, failing lungs but not intubated yet who has a hemoglobin barely below 7. I've seen a bunch of clinicians hem and haw on whether to transfuse or hold off; and ended up deciding that holding off 'for now' might be wiser.
Perhaps “in general” is the magic phrase here. A guideline can be valuable but using EHR to make it an ironclad law can harm some patients (see Erica and KC below). Great blog—reminded me of the critique of hard & fast Vent norms from Martin Tobin out at Hines VA-Loyola. Would be great to have anything Tobin might like to contribute to Sensible Med!
In general, restrictive is better than liberal. There are too many risks for too few benefits. Alloimmunization is one of the risks rarely mentioned and worth a few weeks of fatigue to avoid, in my opinion
Also, keep in mind, that prior to studying transfusion thresholds, people were getting blood willy nilly. Also not good. The problem is, and will always be, a decerebrate approach to care.
Nice article. Having a “1 size fits all” is no doubt the bean-counters dream, and EHR/ hospital admin types live for this stuff. It is helpful for you to have pointed out the “evidence creep” in this area, where the 1 size gets extrapolated to all sizes.
In my field (cardiology), Reality trial showed restrictive (Hb <8) was non inferior to liberal (Hb<10) strategy….but that was only in post MI patients, and excluded shock and active bleeding among other things.
Too bad such a critical review of the COVID “vaccine” was not done by the FDA or Big Pharma....it would have saved countless lives, disability and Billions of dollars....if ever there was an obvious need for a BioWarfare Trials against Humanity it is now!!
One only need think of the homeless gentleman who has no easy way to be reliable to show up for repeat testing to see the folly in this one size fits all approach
May 9, 2023·edited May 9, 2023Liked by Micah T Prochaska
Micah, as a many decade hematologist and blood banker, I agree with you completely. As with almost everything else abused in medicine, the desire to standardize everything (most recently demonstrated with the vents/remdesivir for covid disaster) based on "populations" is wrong in almost every way. Medicine is the ultimate n-of-1 profession; I have yet to meet a standard patient and as vonEye pointed out years ago, knowing everything about a population tells you NOTHING about the patient you are treating now. EMRs have contributed to deprecating medical care in more ways than I can measure -- this is just another.
I can point at many patients who were transfusion justified at levels higher than 7g. And many where multi-units were clearly the right solution. The issue is that small minds take guidelines and immediately make them "rules" (again, witness covid, but also opioid management) and the SJs and bureaucrats destroy quality health care.
Good analysis...wish anyone in the government or administration understood...or cared.
May 9, 2023·edited May 10, 2023Liked by Micah T Prochaska
This is a very meaningful post to me as an APL Leukemia survivor whose survival during induction was based on the 75-100 transfusions I had while hospitalized. As someone whose blood cells in total were brought to near zero as part of induction and with the help of Mylotarg and arsenic, I was always surprised by how stingy the doctors were with the red blood cells, when they were the primary transfusion that resulted in me feeling alive and mentally cogent. The cryo and platelets were never so immediately gratifying as when you have a bag of red transfused. I digress, instead of anticipating what should have been a predictable and regular drop in HB and giving red blood cells in anticipation of the drop - I routinely had to wait for RBC transfusions because my routine CBCs were spaced out in 4-6 hour increments. This meant that RBC transfusions could be delayed 4-5 hours after they would have significantly benefited me because the HB level was a smidge above EBM policy. Just another 6 hours later, my HB would drop to 4 or 3 and I would have to get two bags instead of one! Sustaining people at the clinically lowest needed levels of HB and platelets in my case as well was extremely uncomfortable, and made the experience of being hospitalized with leukemia even more unpleasant due to both the chronic nose bleed and the horrible dysguesia one gets from having a RBC transfusion when one's levels are so abnormally low, and the increased sleep disruptions. When CBC results would be returned, it meant being awoken an additional time for a transfusion I could have had hours earlier before I went to bed in anticipation of my Hb plummeting. Two extra bags of blood before bed would have allowed me to sleep with a little less anxiety and a little more confidence that I would indeed wake up in the mornin. Moreover, it would have spared me the unpleasant disruption of getting awaken a second time in the middle of the night by nurses having to hook up the transfusion with increased urgency, combined with feeling not just exhausted from the disruption but also on the brink of death.
I hemorrhaged after the birth of my first child and the doctor didn’t feel like I needed a transfusion even though my HB had dropped down to 5. He reasoned I was in my mid twenties and would bounce back and it wasn’t worth the potential side effects of receiving blood. I was young and trusted him. Recovery was awful: my hair and nails stopped growing, I stopped sweating, my heart raced for weeks. I was incredibly weak. It took me 6 months to get back to not needing a nap every day (luckily it was my first kid, she was a good sleeper, and I was able to stay home with her and nap when she napped) and over a year before I felt “normal”, though it was another few years before my hb was high enough to give blood again. And then when I did finally donate again it knocked me out for several weeks, so I haven’t tried to donate for over 20 years now. I just don’t want to risk the fatigue.
Over the years I’ve had other friends lose blood during birth and they were all given blood to recover and none of their HB numbers were below 8. They were able to bounce back rapidly. From my experience and watching my friends’ experiences I’d come to the conclusion my original doctor was a quack and a more liberal blood transfusion policy was a good thing. This article was rather depressing that in that all they’re measuring to test success is morality. There’s so much more to receiving blood than not dying.
Well as a physician I have appreciated this EBM policy, but as a patient I found it unbearably cruel. I have Stage IVB ovarian ca, and after a massive debulking surgery including TAH, omentectomy, cholecystectomy, appendectomy, partial hepatectomy, partial diaphragmatic resection I was left, as a 68 year old, with a HB of 7 and was never transfused except for 1 unit intra-op. This required 10 days of post-op care then discharge. I was weaker than a sick kitten, could barely stand up, was short of breath with minimal exertion. Yes I slowly came up on my own in the months that followed. I don't expect anecdote to change anything but we should think long and hard on the impact of this on patients. Outcome may be the same but quality of life surely is not.
Another thought is that the blood supply in the US is constantly short. We dont have the units for liberal transfusion parameters. What we do have is a "patient is symptomatic" option in our EHR to justify transfusion before the patient hits parameters. Ultimately the blood bank decides who gets a transfusion if there is a shortage.
Meta analysis..isn't that when they take a whole bunch of studies or trials, combining both good and bad and hope there are enough good ones to overcome the bad? How do you ever know if all these studies or trials are really efficient, scientific and true?
Sometimes the jump to conclusions is proportional to the profit that can be made. I don't think that's the case here.
May 9, 2023Liked by Micah T Prochaska, Adam Cifu, MD
Micah this is an excellent article. This seems to be a textbook example of the difference between treatment trials and treatment policy trials. I wonder if a different design would have helped ---one in which the threshold was randomized by choosing from 10-20 different possible levels and the primary analysis was of a dose-response type.
Hi Tem, I dont know that we are that far off from each other, but:
1) An imbalance in TIPS after randomization is concerning because that is likely what drove the mortality difference. We dont know that the difference was driven by transfusion strategy, although that is a hypothesis that should be tested. Changing your trial outcome halfway through absolutely is a critical critique, because the design of atrial (recruitment, operations, power, analytic plan) are driven by a scientific question that has a pre-specified outcome. Im not completely dismissing the Villanueva trial, but to suggest that it doesn't leave open questions would be a curious stance.
2. Restrictive transfusion does not save lives (whether in GI bleeding or otherwise). The trials showed NO DIFFERENCE in mortality. This was one of my first points in the blog post. So may clinical story was not anecdotal, but pointing out that clinicians, based on trial data, should feel comfortable that transfusing some with a Hb above 7g/dL and a 5g/dL Hb drop will NOT INCREASE THEIR MORTALITY.
3. Your logic would suggest anemia should never be treated, and the assertion that there is no benefit is not backed up by robust trial data. Trials are needed in outcomes other than mortality. They are out there, but patient-reported outcomes are very difficult to study and the trials have many methodologic issues. Transfusion has risks, yes this is true. The overwhelming majority of physicians vastly overestimate transfusion risk (for all transfusion reactions). We have data on this that we plan to publish.
4. I completely agree. People and funding agencies have to see the need for trials to answer these questions, but they dont when the incorrectly assume that restrictive transfusion saves lives and/or they overestimate the risk of transfusion.
Hi Micah, We're going to have to agree to disagree. There's no question that restrictive transfusion saves lives. It's not true in every context, but it is definitely the case for UGIB and almost certainly for the TRICC population as well. It's right there in black and white on pp. 18 -19 of the Villanueva trial (overall mortality OR=0.55, P=0.02) and p. 414 of the TRICC trial. People can look at the trials and decide for themselves.
Hard to know where to begin with your interpretation of the TIPS data. You have it totally backwards. Restrictive transfusion reduces portal pressures (p. 15), thereby reducing hepatic congestion and the need for TIPS. This is an *advantage* of restrictive transfusion that may have also contributed to the mortality benefit seen with the restrictive strategy. Again, I encourage people to read the trial for themselves.
It's been a nice conversation, but I think you have a lot to learn about how to read the transfusion literature before you can make broad (and baldly inaccurate) statements attacking it.
Hi Tem, Your last comment/sentence is unnecessary, patronizing, not collegial, and mean. It is also not indicative of someone willing to engage in an open honest debate. Your anonymous, I am not. For these reasons, I do agree to disagree.
Has anyone stopped to think about how our entire Red Cross blood bank should be considered contaminated with harmful vaccine spike protein? They do not even ask donors if they are vaccinated or not with the experimental gene therapies. This was a HUGE concern to my family as our infant granddaughter was hospitalized with iron deficiency anemia and a HGB of 5.2. They wanted to transfuse her at the children's hospital and when we requested unvaccinated blood only we were told that was not available. She ended up getting iv iron instead (thank God) but we found out directed donation to her by unvaccinated family members would take a week. It is completely irresponsible to NOT request vaccination status at the time of blood donation given we have no clue the long term side effects and the short term AE's are mounting up daily. Absolute INSANITY has happened to our healthcare system in the last 3 years.
Career hematologist and blood banker here. Love that there is attention being paid to the transfusion medicine literature, but Micah is fundamentally wrong here. He significantly understates the strength of the data for restrictive transfusion approaches. There are literally a dozen high-profile RCTs in different patient populations, and every single one shows the same thing--a restrictive transfusion strategy is noninferior and possibly superior to a liberal strategy. Even the example of "harm" Micah provides of GI bleeding has been directly studied in a well-designed RCT (Villanueva, et al. NEJM 2013). In those patients (non-exanguinating UGIB), a restrictive strategy appeared likely superior. The authors also did a beautiful physiologic correlate showing increased portal pressures in patients receiving more blood, which may explain (at least in part) the inferior outcomes in liberally transfused patients.
The call for a "usual care" control group also misunderstands the objective of these RCTs. When TRICC, etc. were designed, the key was to achieve significant separation in how the two arms were managed. A usual care group posed the danger of insufficient differentiation between the two arms (i.e. fairly similar volumes of RBCs transfused). Micah acknowledges this problem but seemingly fails to make the connection. Only by enforcing different strategies can this issue be avoided. Interestingly, the problem of inter-group separation has been a perennial concern in the transfusion literature (see, for example, the PROPPR trial).
Mortality was chosen as the outcome because mortality prevention is the central objective of transfusion. For example, in the TRICC trial all patients were in the ICU. Few would argue that "symptomatic anemia" is a concern for an intubated and sedated patient. Additionally, it's well understood now that the mere existence of anemia doesn't explain symptoms--and that anemia is often just a marker of the causative underlying process, which is often inflammatory (see PNH, for example, where high-quality data show transfusion does nothing to improve symptoms whereas complement inhibition does).
It is also inaccurate to say that randomized trial results were "biased" in favor of restrictive transfusion because they did not collect data on symptoms of anemia. The trials also prominently failed to collect data on the harm of over-transfusing patients, e.g. FNHTR, alloimmunization, allergic reactions, TACO, etc. These problems are often minimized or simply not understood by physicians who favor giving more blood more often.
It is a major overreach to claim that the transfusion thresholds literature represents an impending "medical reversal." In fact, it's the opposite--these well-designed RCTs reversed the prior belief, based only on bioplausibility, that "more blood is better." I could go on, but the bottom line is that countless patients have benefitted from the body of work that Micah assails.
Hi Tem, A couple of comments:
1) I acknowledged and cited all the RCT's and meta-analyses (I am on guidelines committee, so I have spent EXTENSIVE time reviewing the data from every single trial).
2) The Villanueva trial has an imbalance in the number of TIPS between restrictive and liberal strategies. Thats a problem for obvious reasons. Also, I recently learned from Jeff Carson that the Villanueva trial changed their outcomes half way through the trial. This is also problematic for obvious reasons. Last, I dont know many good clinicians (even those aware of the Villanueva trial) who would feel comfortable not transfusing a GI bleeding patient whose Hb yesterday was 12.5g/dL but is now 7.1g/dL. So the broader point was the dogmatic application of trial data doesn't often serve patients.
3) I am not sure I understand your point about separation of trial arms, and we may be in agreement. Please read the two citations I provided on practice misalignment to understand why TRICC needed a usual care group.
4) Yes, anemia may be a marker of problems. Does that mean you dont think we should conduct studies to determine how to best treat it? Do you think a restrictive transfusion strategy is optimal for all patients and all anemia etiologies. Is mortality the only thing that matters? These were the points I was trying to raise.
Hi Micah,
Thanks for your response. To clarify at the outset: of course I’m not advocating a cookie cutter approach to all patients, and we need to use our clinical judgement to make decisions specific to each case. That said, in the vast majority of patients liberal transfusion is pointless and probably even harmful.
1. I’m confused by your point about TIPS in the Villanueva trial. You’re aware that the “imbalance” in TIPS occurred *after* randomization, right? It’s reported as an outcome in Table 3. This means that an additional advantage of restrictive transfusion is reducing the need for TIPS. I hope we can agree that this reflects a benefit, not a disadvantage, to restrictive transfusion. Regarding the study outcomes, I’m not sure how Jeff would know that they were changed, but even if true it does not on its own constitute a substantive critique of the paper. Restrictive arm patients also had lower overall mortality (by a lot, OR=0.55 and P=0.02), an outcome that is highly relevant regardless. As to your last point that “it’s not what I’ve seen good clinicians do,” this kind of anecdotal thinking is precisely the opposite of what we’re trying to achieve in evidence-based medicine. At my institution, we routinely keep UGIB patients at a Hgb goal of >7 g/L. RCT-level data shows that this practice saves lives.
2. Separation means that a large enough difference in transfused product between the arms is required for a meaningful comparison to occur. With a “usual care” group, there’s no guarantee this will happen.
3. Just to reiterate: 1) anemia is not the cause of symptoms in the vast majority of anemic inpatients, most of whom have other underlying disorders that predominate, 2) it follows that correction of anemia through transfusion provides little/no benefit while incurring risk (as has been shown repeatedly), and 3) the significant potential downsides of transfusion were not adequately considered, if at all, in your piece.
4. It would be huge contribution if you could identify specific patient population(s) that actually benefit from more blood. I genuinely mean that and would be open to changing my mind if high quality data were available.
There's also the wide practice among cardiologists of recommending transfusion above 8 in patients with CAD.
There's also the one in a million case of a floridly overloaded patient, no CHF, failing lungs but not intubated yet who has a hemoglobin barely below 7. I've seen a bunch of clinicians hem and haw on whether to transfuse or hold off; and ended up deciding that holding off 'for now' might be wiser.
Perhaps “in general” is the magic phrase here. A guideline can be valuable but using EHR to make it an ironclad law can harm some patients (see Erica and KC below). Great blog—reminded me of the critique of hard & fast Vent norms from Martin Tobin out at Hines VA-Loyola. Would be great to have anything Tobin might like to contribute to Sensible Med!
Great to see you posting here Micah -- I miss running into you in the halls of Mitchell Hospital. Hope you are doing well!
In general, restrictive is better than liberal. There are too many risks for too few benefits. Alloimmunization is one of the risks rarely mentioned and worth a few weeks of fatigue to avoid, in my opinion
Also, keep in mind, that prior to studying transfusion thresholds, people were getting blood willy nilly. Also not good. The problem is, and will always be, a decerebrate approach to care.
Nice article. Having a “1 size fits all” is no doubt the bean-counters dream, and EHR/ hospital admin types live for this stuff. It is helpful for you to have pointed out the “evidence creep” in this area, where the 1 size gets extrapolated to all sizes.
In my field (cardiology), Reality trial showed restrictive (Hb <8) was non inferior to liberal (Hb<10) strategy….but that was only in post MI patients, and excluded shock and active bleeding among other things.
Too bad such a critical review of the COVID “vaccine” was not done by the FDA or Big Pharma....it would have saved countless lives, disability and Billions of dollars....if ever there was an obvious need for a BioWarfare Trials against Humanity it is now!!
One only need think of the homeless gentleman who has no easy way to be reliable to show up for repeat testing to see the folly in this one size fits all approach
Micah, as a many decade hematologist and blood banker, I agree with you completely. As with almost everything else abused in medicine, the desire to standardize everything (most recently demonstrated with the vents/remdesivir for covid disaster) based on "populations" is wrong in almost every way. Medicine is the ultimate n-of-1 profession; I have yet to meet a standard patient and as vonEye pointed out years ago, knowing everything about a population tells you NOTHING about the patient you are treating now. EMRs have contributed to deprecating medical care in more ways than I can measure -- this is just another.
I can point at many patients who were transfusion justified at levels higher than 7g. And many where multi-units were clearly the right solution. The issue is that small minds take guidelines and immediately make them "rules" (again, witness covid, but also opioid management) and the SJs and bureaucrats destroy quality health care.
Good analysis...wish anyone in the government or administration understood...or cared.
This is a very meaningful post to me as an APL Leukemia survivor whose survival during induction was based on the 75-100 transfusions I had while hospitalized. As someone whose blood cells in total were brought to near zero as part of induction and with the help of Mylotarg and arsenic, I was always surprised by how stingy the doctors were with the red blood cells, when they were the primary transfusion that resulted in me feeling alive and mentally cogent. The cryo and platelets were never so immediately gratifying as when you have a bag of red transfused. I digress, instead of anticipating what should have been a predictable and regular drop in HB and giving red blood cells in anticipation of the drop - I routinely had to wait for RBC transfusions because my routine CBCs were spaced out in 4-6 hour increments. This meant that RBC transfusions could be delayed 4-5 hours after they would have significantly benefited me because the HB level was a smidge above EBM policy. Just another 6 hours later, my HB would drop to 4 or 3 and I would have to get two bags instead of one! Sustaining people at the clinically lowest needed levels of HB and platelets in my case as well was extremely uncomfortable, and made the experience of being hospitalized with leukemia even more unpleasant due to both the chronic nose bleed and the horrible dysguesia one gets from having a RBC transfusion when one's levels are so abnormally low, and the increased sleep disruptions. When CBC results would be returned, it meant being awoken an additional time for a transfusion I could have had hours earlier before I went to bed in anticipation of my Hb plummeting. Two extra bags of blood before bed would have allowed me to sleep with a little less anxiety and a little more confidence that I would indeed wake up in the mornin. Moreover, it would have spared me the unpleasant disruption of getting awaken a second time in the middle of the night by nurses having to hook up the transfusion with increased urgency, combined with feeling not just exhausted from the disruption but also on the brink of death.
I hemorrhaged after the birth of my first child and the doctor didn’t feel like I needed a transfusion even though my HB had dropped down to 5. He reasoned I was in my mid twenties and would bounce back and it wasn’t worth the potential side effects of receiving blood. I was young and trusted him. Recovery was awful: my hair and nails stopped growing, I stopped sweating, my heart raced for weeks. I was incredibly weak. It took me 6 months to get back to not needing a nap every day (luckily it was my first kid, she was a good sleeper, and I was able to stay home with her and nap when she napped) and over a year before I felt “normal”, though it was another few years before my hb was high enough to give blood again. And then when I did finally donate again it knocked me out for several weeks, so I haven’t tried to donate for over 20 years now. I just don’t want to risk the fatigue.
Over the years I’ve had other friends lose blood during birth and they were all given blood to recover and none of their HB numbers were below 8. They were able to bounce back rapidly. From my experience and watching my friends’ experiences I’d come to the conclusion my original doctor was a quack and a more liberal blood transfusion policy was a good thing. This article was rather depressing that in that all they’re measuring to test success is morality. There’s so much more to receiving blood than not dying.
*mortality, not morality
Well as a physician I have appreciated this EBM policy, but as a patient I found it unbearably cruel. I have Stage IVB ovarian ca, and after a massive debulking surgery including TAH, omentectomy, cholecystectomy, appendectomy, partial hepatectomy, partial diaphragmatic resection I was left, as a 68 year old, with a HB of 7 and was never transfused except for 1 unit intra-op. This required 10 days of post-op care then discharge. I was weaker than a sick kitten, could barely stand up, was short of breath with minimal exertion. Yes I slowly came up on my own in the months that followed. I don't expect anecdote to change anything but we should think long and hard on the impact of this on patients. Outcome may be the same but quality of life surely is not.
Another thought is that the blood supply in the US is constantly short. We dont have the units for liberal transfusion parameters. What we do have is a "patient is symptomatic" option in our EHR to justify transfusion before the patient hits parameters. Ultimately the blood bank decides who gets a transfusion if there is a shortage.
Yes, if the blood supply only allows for “life saving” parameters then that’s what we’re left with. I
Meta analysis..isn't that when they take a whole bunch of studies or trials, combining both good and bad and hope there are enough good ones to overcome the bad? How do you ever know if all these studies or trials are really efficient, scientific and true?
Sometimes the jump to conclusions is proportional to the profit that can be made. I don't think that's the case here.
Micah this is an excellent article. This seems to be a textbook example of the difference between treatment trials and treatment policy trials. I wonder if a different design would have helped ---one in which the threshold was randomized by choosing from 10-20 different possible levels and the primary analysis was of a dose-response type.