A Multicenter, Randomized, Controlled Clinical Pilot Trial of the Feasibility of an Intensive RBC Transfusion Policy for Patients with Acute Leukemia Treated with Induction Chemotherapy or Stem Cell Transplant.
Bibliographic record
Abstract
Abstract Introduction: Patients with AML or ALL undergoing induction chemotherapy or SCT are at risk for hemorrhage. Hemoglobin (Hb) concentration may affect bleeding risk in thrombocytopenic patients. We performed a single-blinded pilot RCT to evaluate the feasibility of conducting a larger RCT to determine the effect of Hb on bleeding risk in thrombocytopenic patients. Objectives of the pilot RCT were: (1) to estimate the rate and variability of bleeding during the period of thrombocytopenia; (2) to confirm feasibility of the larger trial by demonstrating that: (a) it is possible to maintain patients’ Hb within the targeted range; (b) patients assigned to the intensive threshold do not have increased donor exposure; (c) it will be feasible to enroll the required number of patients; and (d) bleeding can be systematically documented. Methods: Adults with AML or ALL undergoing induction chemotherapy or HLA-matched myeloablative allogeneic SCT were eligible. Consecutive eligible patients were randomly assigned to one of 2 treatment groups: standard RBC transfusion strategy (control group) and intensive RBC transfusion strategy (experimental group). Groups were stratified by treatment centre and diagnosis. Patients in the control group were transfused 2 RBC units when their Hb was <8g/dL to maintain their Hb between 8–10g/dL. Patients in the experimental group were transfused 2 RBC units when their Hb was <12g/dL to maintain their Hb above this threshold. Bleeding was documented daily by a blinded study assessor using a standardized form and protocol. Primary outcomes included: bleeding estimates; proportion of days with a Hb within targeted range; blood product utilization (RBC and platelets [plt]); and hospital length of stay (LOS). Secondary outcomes included the ability to document bleeding using the standardized protocol. Two-sided t-tests were used to compare blood product utilization and LOS between groups. Results: 60 patients were enrolled: 29 (control group) and 31 (experimental group). The mean age was 47.9 (range 18–77) years. 30 patients had newly diagnosed AML, 9 had relapsed AML, 5 had ALL, and 16 were undergoing SCT. Patients in the control group had Hb of 8–10g/dL on 56.4% of days. Patients in the experimental group had Hb>12g/dL 56.5% of days. The control group received fewer RBC transfusions (units/day) than the experimental group (0.167 vs 0.320, p<0.0001). The mean number of plts transfused (units/day) was not different for control and experimental groups (0.851 vs 1.063, p=0.383). The mean number of donor exposures (plt and RBC transfusions) was not different between control and experimental groups (26.9 vs 27.5, p=0.923). There was a nonsignificant trend towards a shorter LOS in the experimental group (27.9 vs 23.7, p=0.112). Bleeding data are undergoing blinded adjudication. Conclusions: It is feasible to enroll the required number of patients for a large RCT to investigate the effect of Hb on bleeding risk. Patients assigned to the intensive strategy had increased RBC utilization but no increase in total donor exposures. Funded by a grant from Canadian Blood Services.
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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 | 0.009 | 0.013 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
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".