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.
Notice bibliographique
Résumé
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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,009 | 0,013 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,003 | 0,002 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,002 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,003 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,007 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».