Multi-Arm Multi-Stage Adaptive Platform Trial (Apt) For The Acute Treatment Of Traumatic Brain Injury
Posted Date: Mar 19, 2025
- Investigator: Laura Ngwenya
- Specialties: Emergency Medicine, Neurosurgery
- Type of Study: Drug
The primary objective is to confirm safety, determine futility, and identify whether any of the active treatment interventions improve the functional outcome in participants with TBI as defined by a Glasgow Coma Scale (GCS) score of 9 to 15 and a positive head computerized tomography (CT+) scan identifying acute traumatic brain injury. Multi-center, double-blind, placebo-controlled, adaptive platform, precision medicine trial conducted under a single multi-arm, multi-stage (MAMS) study with parallel groups. Participants will be randomized to receive one of four possible treatment interventions: Atorvastatin calcium (ATOR) Minocycline hydrochloride (MINO) Candesartan cilexetil (CAND) Matching Placebo
Criteria:
Patients Aged 18-65Yrs And Present To The Hospital Within 24 Hours Of Injury. Participants Must Be Enrolled And Treated With First Dose Of Investigational Product Within 24 Hours Of Injury.
Keywords:
Tbi, Acute
For More Information:
Mikayla Wallace
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wallamk@ucmail.uc.edu