Factors in the Initial Resuscitation of Patients With Severe Trauma
Notice bibliographique
Résumé
Importance: Patients with bleeding and coagulopathic trauma often require more transfusions and have higher mortality rates, motivating research on improving hemostatic strategies. Objective: To evaluate the replacement of clotting factors with frozen plasma (FP) or factor concentrates (fibrinogen concentrate [FC] and prothrombin complex concentrate [PCC]) in the initial resuscitation of patients with trauma. Design, Setting, and Participants: This multicenter, parallel-control, superiority randomized clinical trial was conducted at 6 level I trauma centers in Canada, between April 2021 and February 2023. Eligible patients were those with massive hemorrhage protocol (MHP) activation on admission and aged 16 years or older. Patients were excluded if they received more than 2 red blood cell (RBC) units either before hospital admission or in the hospital prior to randomization or if they had a catastrophic head injury. Follow-up was completed on March 25, 2023. The primary analysis was based on the modified intention-to-treat approach. Interventions: The intervention group received FC 4 g and PCC 2000 IU in MHP packs 1 and 2. The control group received 4 FP units. Concurrently, patients received 4 RBC units (both packs) and 1 dose of platelets (pack 2). After pack 2, FP was administered at clinician discretion. Main Outcomes and Measures: Primary outcome was the number of allogeneic blood product (RBC, FP, and platelet) units administered within 24 hours. Secondary outcomes included incidence of thromboembolic events, duration of intensive care unit stay, and mortality. Results: Of the 217 patients enrolled, 107 were randomly assigned to the FC-PCC group and 110 to the FP group; 137 patients were included in the primary analysis (66 in the FC-PCC group and 71 in the FP group). Baseline characteristics were similar between groups (median [IQR] age, 38 [29-55] years; 111 males [81.0%]). Among these patients, 95 (69.3%) had blunt mechanisms of injury, and the median (IQR) Injury Severity Score was 29 (19-43). Mean 24-hour transfusions were 20.8 (95% CI, 16.7-25.9) units in the FC-PCC group and 23.8 (95% CI, 19.2-29.4) units in the FP group. The mean ratio was 0.87 (1-sided 97.5% CI, 0.00-1.19; P = .20 for superiority). No significant differences were found in thromboembolic complications or 24-hour and 28-day mortality. The trial was terminated after the interim analysis showed conditional power of less than 25%, requiring an impractically large sample to show superiority. Conclusions and Relevance: In this randomized clinical trial, clotting factor concentrates were not superior to FP for initial resuscitation of patients with trauma. Efficacy and safety outcomes were similar across the treatment groups. Trial Registration: ClinicalTrials.gov Identifier: NCT04534751.
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 distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
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 tête enseignante, 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 ».