Transfusion of Red Cells in Hematopoietic Stem Cell Transplantation (TRIST Study): A Randomized Controlled Trial Evaluating 2 Red Cell Transfusion Thresholds
Bibliographic record
Abstract
Abstract Background Evidence regarding red blood cell (RBC) transfusion practices in Hematopoietic Stem Cell Transplantation (HSCT) is lacking. As a result, the impact of RBC transfusions on outcomes following HSCT is not well understood. We designed a non-inferiority Randomized Controlled Trial evaluating a restrictive and liberal RBC transfusion strategy with a primary endpoint of Health Related Quality of Life (HRQOL) as measured by the FACT-BMT scale at Day 100. Methods Patients with a hematologic malignancy requiring HSCT were randomized to either a restrictive (Hemoglobin (Hgb) threshold <70g/L) or liberal (Hgb threshold <90g/L) RBC transfusion strategies between Day-0 and Day-100). Permutated randomization blocks of 2 and 4 were used. Patients were stratified by centre and by type of HSCT. The non-inferiority margin selected for the study corresponds to a 12% absolute difference between groups in FACT-BMT score relative to baseline. Patients received a RBC transfusion if the Hgb was below the assigned threshold with the assessment of hemoglobin according to institutional practice (most often on a daily basis) with 2 units of RBC prescribed at the assigned threshold. The following endpoints were collected: 1) HRQOL by FACT-BMT, FACT-Anemia and EQ-5D at Baseline, Day 7, 14, 28, 60 and 100, 2) Transplant related mortality, Length of Hospital Stay, ICU admissions, Incidence and grade of acute graft versus host disease, Incidence of Serious infections, Transfusion requirements, Bleeding as per WHO Bleeding Scale, Incidence of adverse transfusion reactions, Bearman Toxicity Score and Sinusoidal Obstruction Syndrome. The primary endpoint was compared using a generalized linear model while accounting for any baseline differences in scores. Results We enrolled 300 patients (150 allogeneic and 150 autologous) undergoing HSCT between 28 Mar 2011 and 3 Feb 2016 at 4 Canadian adult HSCT centres. The difference in the overall mean pre-transfusion hemoglobin per patient over the study period between the groups was 13.7(±9.8) g/L. Statistical non-inferiority was detected between the liberal and the restrictive strategy as measured by the FACT-BMT at 100 days post-HSCT (Estimated difference in ratios between groups, -1.64%; 95% confidence interval, -0.07 to 0.04; P=0.0001 for non-inferiority) or any other time points (Days 7, 14, 28 and 60). In fact, the FACT BMT scores at all time points were higher for patients in the restrictive transfusion group. The median (IQR) number of RBC units transfused was lower in the restrictive-strategy group than in the liberal-strategy group [2(2-6) vs. 4(2-6), p=0.10], but this did not reach statistical significance. There were no statistical differences in any of the outcomes between the 2 groups. Conclusions The results of our study support the use of a restrictive RBC transfusion strategy as compared with a liberal strategy in patients undergoing HSCT as the HRQOL are similar and there are no appreciable differences in HSCT associated clinical outcomes. Figure Figure. Disclosures Xenocostas: Janssen Inc.: Research Funding.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".