Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062696) titled 'Whole blood transfusion for traumatic hemorrhage: a systematic review and meta-analysis of randomized controlled trials' on Sept. 1.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Osaka Medical and Pharmaceutical University

Condition: Condition - Traumatic hemorrhage and hemorrhagic shock Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate whether a transfusion strategy including whole blood reduces 28- or 30-day all-cause mortality compared with blood component therapy in patients with traumatic hemorrhage or hemorrhagic shock. Secondary objectives are to assess 24-hour all-cause mortality, 24-hour total transfusion requirements, time to hemostasis, re-intervention for bleeding, 24-hour crystalloid volume, ventilator-free days, ICU length of stay, total hospital stay, neurological functional Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Individual- or cluster-randomized parallel-group controlled trials enrolling adult or pediatric patients with acute traumatic hemorrhage or hemorrhagic shock resulting from trauma (excluding burns), defined by individual trials through active bleeding, hypotension, elevated shock index, activation of massive transfusion protocols, or clinical requirement for emergent blood transfusion. The intervention must be any transfusion strategy including whole blood (such as cold-stored low-titer group O whole blood [LTOWB], type-specific whole blood, fresh whole blood, or modified whole blood), and the comparator must be blood component therapy without whole blood (such as 1:1:1 component protocols). No restriction will be placed on injury mechanism (blunt or penetrating), presence of traumatic brain injury, severity, setting of transfusion initiation (prehospital or in-hospital), country, language, or publication status. Key exclusion criteria - Non-randomized studies, quasi-randomized studies using predictable allocation (e.g., alternation, medical record or patient numbers, birth dates, admission dates), crossover trials, and animal or healthy-volunteer studies; non-traumatic hemorrhage (e.g., gastrointestinal bleeding, obstetric hemorrhage, ruptured aortic aneurysm, elective perioperative bleeding) and isolated burn injury; mixed-population studies without separable trauma data; studies using autologous transfusion only; trials comparing different storage durations of whole blood where both groups receive whole blood; and duplicate reports of the same trial, which will be linked as one trial family. Target Size - 3000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 01 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2026 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071786

Disclaimer: Curated by HT Syndication.