Hébert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care.
Bạn đang xem: The tricc trial: restrictive transfusion in intensive care does not increase mortality
Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. Erratum in: N Engl J Med 1999 Apr1;340(13):1056. PubMed PMID: 9971864.In patients with a critical illness does a restrictive sầu transfusion strategy (to a target of 70 – 90 g/L, transfusion trigger
TYPE OF STUDY
Multi centre randomised controlled trial (22 tertiary level and 3 ‘community’ ICUs in Canada)Computer randomised using permuted blocks of 4 or 6, và stratified by center APACHE score of >15 và 15 or lessNon-blindedPOPULATION
Inclusion criteria:Expected lớn stay in ICU > 24 hoursHb concentration of 90 g/L or less within 72 hours of admission to ICUConsidered to be euvolaemic following initial treatment by ICU teamExclusion criteria:Age Inability lớn receive blood productsActive sầu bleeding at time of enrolment (evidence of ongoing blood loss và a decrease in Hb concentration of 30 g/L in the preceding 12 hours OR a requirement for at least 3 units of packed RBCs in the same period)Chronic anaemiaPregnancyBrain deathImminent death (Consideration of withdrawal of treatment/DNR orderAdmission for a routine cardiac surgical procedurePrevious transfusionEnrolment in other studyINTERVENTIONS/ COMPARISONS
Restrictive transfusion strategy (lớn a target of Hb 70 – 90 g/L, transfusion trigger Hb Liberal transfusion strategy (lớn target of Hb 100 – 120 g/L, transfusion trigger HbOUTCOMES
Average daily Hb concentrations differed significantlyRestrictive 85 +/- 7 g/L, Liberal 107 +/- 7 g/LNumber of units of RBCs transfused was significantly reduced (RRR 0.54) in the restrictive sầu group (2.6 +/- 4.1 units) compared with the liberal group (5.6 +/- 5.3 units) (p Primary outcomerate of death from all causes at 30 daysNo significant differenceRestrictive sầu 18.7%, Liberal 23.3% (95%CI -0.84 – 10.2%, p = 0.11)Secondary outcomesMortality rates during hospitalisation were lower in the restrictive group, but there was no difference in ICU mortality or 60 day mortalityinpatient mortality: 22.2% vs. 28.1% (ARR 5.8%; P=0.05)ICU mortality: 13.9% vs. 16.2% (ARR 2.3%; P=0.29)60-day mortality: 22.7% vs. 26.5% (ARR 3.7%; P=0.23)There were slightly lower adjusted multiple-organ dsyfunction scores in the restrictive group (10.7 +/- 7.5 vs 11.8 +/- 7.7; p=0.03)Subgroup analysesWhen analysed by sub-group baseline characteristics remained similar between treatment armsNo differences in survival when adjusted for:traumacardiac diseasesevere infections or septic shockThere was lower mortality in the restrictive group for these a priori determined subgroups:APACHE II ≤20: 8.7% vs 16.1% (95% CI 1.0% – 13.6%, p = 0.03)AgeAdjusted multiple-organ dysfunction scores were statistically significantly lower in the restrictive sầu group. compared with the liberal group, in the APACHE Adverse cardiac events (e.g. cardiac ischaemia, pulmonary oedema, cardiac arrest) were more comtháng in the liberal group: 13.2% vs. 21% (ARR 7.8%; PAll of the liberal group received blood transfusion, whereas 33% of the restrictive sầu group did not receive sầu transfusion
Commentary
This is a landmark practice-changing classic of ICU research, but it is not without its flaws.The study raised concerns about the harms of blood transfusion and questioned the presumed benefit of increasing oxygen delivery – at least by transfusion – in the critically ill.Practice guidelines today generally tư vấn a transfusion trigger of Hb 70 g/L in critically ill patients as a result, except for selected patient subgroups (e.g. cardiac patients)Subsequent studies have supported similar targets in patients with upper GI haemorrhage & septic shockThere is considerable controversy about the optimal Hb target in individual ICU patients và there are concerns over the external validity & power of the TRICC trialStrengths
Randomised, multicentre controlled trialAppropriately chosen primary/secondary outcomesPower calculation performed, but…calculated to detect a 5% difference in 30d mortalitytarget sample kích cỡ of 1620 patients was determined by an interim analysis suggesting a higher than expected mortality ratesee criticisms belowused intention to lớn treat analysisRelevant population group (i.e. APACHEII scores consistent with critical illness)Comparable healthcare setting khổng lồ the Australian settingHighlighted how a simple, inexpensive lớn institute intervention could significantly reduce costs and lead to lớn apparently superior patient outcomesCriticisms
The total number of patients enrolled (n=838) resulted in the study being underpowered & thus prone to lớn type II errorOnly ~12.9% of total assessed patients were enrolled in the trial, with a large number of them being excluded due lớn physician refusal (selection bias)APACHE II score subgroup stratification was altered after the fact (This study may have been subject to lớn practice misalignmenta survey by Hebert et al (1998) showed that standard practice was not to transfuse patients to lớn Hb >100 g/L and most clinicians would use a target higher than 70 g/L in patients with ischaemic heart disease. Allocation of these patients to lớn the corresponding treatment arms might have been expected to cause harm.External validity is limited by the following:Exclusion of patients following cardiac surgery removed a large population of critically ill patients that may require significant volumes of blood and blood products – this is markedly different to the Alfred ICU populationThe study not include long-stay ICU patients who required transfusion later (i.e. onphối of anaemia had to occur within 72 hours)There was a significant difference in the percentage of patients with cardiovascular disease between those excluded from the trial & those enrolled (20% vs 26% respectively) – excluded pateints also tended khổng lồ be older – decreasing ability to lớn apply results across a broader population297 patients were excluded for having had a transfusion prior khổng lồ ICU that increased their Hb to >90 g/L – may reduce applicability khổng lồ certain patient groups who may receive sầu frequent or be at high likelihood of transfusionStudy conducted prior khổng lồ routine use of leucodepleted PRBCs in Canadomain authority – would repeating the trial with leucodepleted PRBCs diminish the significant differences?The TRICC study is a landmark trial that supports the use of a restrictive sầu transfusion strategy targeting Hb> 70 g/L in ICU patients. However, the optimal Hb target in different patient subgroups (e.g. cardiac disease) remains uncertain.Concerns remain over the external validity of the study and the fact that it was underpowered.
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Tagged chris nickson, Hebert et al 1998, kent lavery, liberal, red blood cell transfusion, restrictive sầu, TRICC trial Post navigation
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