Multi-Institutional Phase 2/3 Trial of Fresh Frozen Plasma (FFP) in Patients with Moderate to Severe Traumatic Brain Injury (TBI)
Abstract
This study will be a Phase 2/3, randomized, multicenter study performed under Exception From Informed Consent (EFIC) to evaluate the efficacy of administration of FFP in subjects with moderate to severe TBI across eight sites with a history of performing studies under EFIC. The study aims to determine whether administration of 2 units of FFP in patients with moderate to severe TBI due to cerebral contusions attenuates hemorrhagic and/or ischemic progression of brain lesions during the early (24 hours) post- injury period.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2023
- Accession Number
- AD1221118
Entities
People
- Hasan B Alam
- Sharnia Lashley
Organizations
- Northwestern University