Anders Perner - When to Pull the Transfusion Trigger?
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The management of the septic patient in ICU is a recurrent topic for debate amongst intensivists. The decision of if and/or when to give blood transfusions is one of the key sources of contention. Dr Anders Perner is one of the most qualified people to weigh in on this debate. In this talk from SMACC Chicago, he delivers his stance on when to pull the transfusion trigger. Dr Anders Perner is an Intensive Care Specialist at Rigshospitalet and a professor in intensive care at Copenhagen University. He is the chairman of the Scandinavian Critical Care Trials Group and the strategic research program “New resuscitation strategies in patients with severe sepsis’. The contents of this talk are based on the findings of the TRISS trial - Transfusion Requirements in Septic Shock. This trial, Lower versus Higher Hemoglobin Threshold for Transfusion in Septic Shock was published in the NEJM in October 2014. The aim was to evaluate the recommendations from the Surviving Sepsis Campaign regarding transfusion in septic shock. The recommendation is that after the first 6 hours, transfusion threshold should be a Hb <7g /></9g></ 9g/dL) or a lower transfusion threshold group (Hb</ 7g/dL). They each received 1 unit of leukoreduced PRBC when they reached their respective transfusion threshold. The primary outcome was death within 90 days of randomisation. In this SMACC talk, some of the key findings and limitations of the trial are discussed. So check out this talk and then read the full article available here to see if you agree with 7g/dL – the new normal. What’s your transfusion trigger? Is it time to rethink it?
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Anders Perner - When to Pull the Transfusion Trigger?
- 1. When to pull the Tx- trigger? University of Copenhagen Anders Perner
- 2. University of Copenhagen COIs Research funds from Fresenius Kabi, CSL Behring
- 3. Royal North Shore Hospital - Sydney
- 4. TRISS TRIAL
- 5. After fluid resuscitation, MAP is 75, HR 100 on 0.1mcg/kg/min of NA Hb is 8.5 g/dl and ScvO2 50% What would you do next? Early sepsis case Emerg Med J 2010;27:110-15
- 6. 0 10 20 30 40 50 60 70 80 90 100 US EM ANZ ICU ANZ EM UK EM UK ICU US ICU Transfuse until Hb > 10 g/dl
- 7. 0 10 20 30 40 50 60 70 80 90 100 US EM ANZ ICU ANZ EM UK EM UK ICU US ICU Transfuse until Hb > 10 g/dl
- 8. Transfuse until Hb > 10 g/dl 0 10 20 30 40 50 60 70 80 90 100 US EM ANZ ICU ANZ EM UK EM UK ICU US ICU
- 9. Transfuse until Hb > 10 g/dl 0 10 20 30 40 50 60 70 80 90 100 US EM ANZ ICU ANZ EM UK EM UK ICU US ICU
- 10. SSC First 6 hours: Hematocrit above 30 percent if ScvO2 < 70% EGDT protocol
- 12. More patients Tx‘ed in EGDT vs usual care groups in ProCESS 14 vs 8% ARISE 14 vs 7% ProMise 9 vs 4%
- 13. More patients Tx‘ed in EGDT vs usual care groups in ProCESS 14 vs 8% ARISE 14 vs 7% ProMise 9 vs 4% Rivers 64 vs 19%
- 16. • Benefit vs. harm • Triggers • Blind spots • Expensive and limited resource Blood Tx
- 17. Odds for Tx given in ICU • Sweden 5.0 • Denmark 4.0 • USA 3.8 • China 3.3 • Canada 1.0 • UK 0.9 • France 0.9 • NZ 0.5 SAFE TRIPS 2007
- 19. Risks of transfusion Infectious Non-infectious Storage-lession Immuno-modulation Benefits vs harms Risks of anemia Low DO2 Ischemia Organ dysfunction Multiple organ dysfunction
- 20. TRISS TRIAL
- 22. 1000 adult ICU patients with septic shock 1 unit leuko-reduced RBCs at Hb < 7 g/dl 1 unit leuko-reduced RBCs at Hb < 9 g/dl Hb < 9 g/dl TRISS TRIAL
- 23. Hb Tx-triggers Chest pain Hypotension Tachycardia Heart failure Fatigue SvO2 / ScvO2 Lactate ECG-dynamics SAP x heart rate Severity Cardiac output
- 27. Median no. of units Tx’ed Lower Threshold : 1 (IQR 0-3) Higher Threshold : 4 (IQR 2-7) (P <0.001) TRISS TRIAL
- 29. Many more red cells vs. Sustained severe anemia TRISS TRIAL
- 30. Deaths within 90 days TRISS TRIAL
- 31. Primary analysis supported by subgroup analyses Age > 70 years Chronic cardiovascular disease Severely ill - SAPS II > 53 TRISS TRIAL
- 32. and… post-hoc subgroup analyses Inclusion < 6 h of ICU admission TRISS TRIAL
- 33. and… post-hoc subgroup analyses Inclusion < 6 h of ICU admission Lactate > 4 mM at randomisation TRISS TRIAL
- 34. Lars B Holst et al. BMJ 2015;350:bmj.h1354 ©2015 by British Medical Journal Publishing Group
- 35. RE-update 8000 patients randomised in lower risk of bias trials of Tx-triggers
- 36. RR 0.97 (0.79-1.19) for mortality Unpublished
- 37. 3000 critically ill patients randomised in lower risk of bias trials of Tx-triggers
- 38. RR 0.92 (0.80-1.06) for mortality Holst et al. BMJ 2015
- 39. • No effect on mortality • Fewer patients Tx’ed and fewer Tx’s 7 g/dl as the new normal
- 40. • Myocardial infarction • Bleeding • Severe brain damage Blind spots
- 42. 200,000 MI patients can’t be wrong?
- 44. Or 20,000 trauma patients? Perel et al. PLoS Med 2014
- 45. Or 20,000 trauma patients? Perel et al. PLoS Med 2014
- 46. • Tx in MI - association with increased mortality • Tx in trauma – association with increased mortality in low risk patients • Severe brain damage – very little data Blind Tx-spots
- 48. ‘7 g/dl - the new normal’ ?MI, bleeding, brain damage?
Editor's Notes
- I am also happy to say that results from our trial are being co-published in the NEJM along with this presentation
- The clinical implications of the TRISS trial results is that it is safe using a lower Hb threshols (7g/dl) to guide RBC Tx in patients with septic shock resulting in fewer transfusions and fewer patients being transfused
- But we have very litte evidence from RCTs to help us guide the transfusion practice in these patients. And we were concerned about the lack of efficacy data and the Safety issue because data from the landmark trial of TRICC published 15 years ago showed the potential for harm with a liberal transfusion strategy in subgroup of critically ill patients.
- I am also happy to say that results from our trial are being co-published in the NEJM along with this presentation
- We ended up with 32 including sites in denmark, Sweden, Norway and Finland
- So we designed a randomised, multicentre, partly blinded trial, using computer generated allocation sequence, including patients with septic shock and a Hb below 9 g/dl and used variable permuted block-randomisation stratified for site and heamotological malignancy to assign patients to either transfusion with single units of prestorage leukocyte depleted RBCs suspended in SAGM at 7 or 9 g/dl. Or below It was not feasible to blind the trial but assessors of mortality , our safety committee and the trial statistician were all blinded for the intervention The intervention lastet until ICU discharge or up to 90 days of follow up
- This diagram shows the patient flow: We assessed 1224 partients fulfilling all 4 inclusion criterias Excluding 219 patients for various reasons- skift
- Patients were excluded if they had previously been randomized, for medical reasons, if they had received blood transfusion during current ICU admission, if there was documented wish against transfusion or if consent could not be obtained. Fifteen patients fulfilled two exclusion criteria.
- Two of the last enrolled patients withdrew their consent after randomisation and another 21 patients only gave consent for use of mortality data leaving us with 998 patients in analysis and 977 patients in the analysis of secondary outcomes Twenty one patients 14 in the low group and 7 in then high group only gave consent for data use for the primary outcome. Data leaving us with 977 patients for secondary outcome analysis 62 discontinued the trial protocol 21 only allowed mortality data to be used and no follow up data. 41 had discontiunued protocol and stopped intervention but continued data registration
- That transends to a median of one unit in the lower group and four units in the higher group
- Shown are median daily lowest levels of blood hemoglobin in the lower and higher transfusion threshold groups. Below we have days since randomisation vs blood hB level in g/dl. Baseline a median of 8.4 g/dl. Dots and squares show median with interquartile ranges. We have a good separation in terms of hb leves. Baseline values were the lowest blood hemoglobin measured in the 24 hours prior to randomization. Day 1 was from the time of randomization to the end of that day and lasted median 15 hours in the lower- and 14 hours in the higher-threshold group. The dots denote medians and the bars 1st and 3rd quartiles.
- The clinical implications of the TRISS trial results is that it is safe using a lower Hb threshols (7g/dl) to guide RBC Tx in patients with septic shock resulting in fewer transfusions and fewer patients being transfused
- survival curves censored at day 90 for the two intervention groups in the intention-to-treat population. Kaplan Meier analysis showed that the survival time did not differ significantly between the two groups. Cox regression analysis adjusted for the stratification variables showed a p-value of 0.41
- Subgroup analysis did not show any significant heterogeneity between the prespecified group of patients with age above 70 years, History with chronic CVD (beskriv…) And SAPS II score above 53 equal to 50% mortality
- Subgroup analysis did not show any significant heterogeneity between the prespecified group of patients with age above 70 years, History with chronic CVD (beskriv…) And SAPS II score above 53 equal to 50% mortality
- Subgroup analysis did not show any significant heterogeneity between the prespecified group of patients with age above 70 years, History with chronic CVD (beskriv…) And SAPS II score above 53 equal to 50% mortality
- Fig 4 Forest plot of mortality in lower risk of bias trials. Size of squares for risk ratio reflects weight of trial in pooled analysis. Horizontal bars represent 95% confidence intervals
- The recent Cochrane review by Carsnon an collegeues showed us that regarding mortality the evidence is not clear when comparing a restrictive and a liberal transfusion strategy. Very few data on septic shock patients.
- The recent Cochrane review by Carsnon an collegeues showed us that regarding mortality the evidence is not clear when comparing a restrictive and a liberal transfusion strategy. Very few data on septic shock patients.
- The recent Cochrane review by Carsnon an collegeues showed us that regarding mortality the evidence is not clear when comparing a restrictive and a liberal transfusion strategy. Very few data on septic shock patients.
- The recent Cochrane review by Carsnon an collegeues showed us that regarding mortality the evidence is not clear when comparing a restrictive and a liberal transfusion strategy. Very few data on septic shock patients.
- The clinical implications of the TRISS trial results is that it is safe using a lower Hb threshols (7g/dl) to guide RBC Tx in patients with septic shock resulting in fewer transfusions and fewer patients being transfused
- The clinical implications of the TRISS trial results is that it is safe using a lower Hb threshols (7g/dl) to guide RBC Tx in patients with septic shock resulting in fewer transfusions and fewer patients being transfused
- The clinical implications of the TRISS trial results is that it is safe using a lower Hb threshols (7g/dl) to guide RBC Tx in patients with septic shock resulting in fewer transfusions and fewer patients being transfused