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Beta Blocker Use In Traumatic Brain Injury Based On The High-Sensitive Troponin T Status

NCT04508244 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 771

Last updated 2023-09-28

No results posted yet for this study

Summary

Beta blockers (BB) play an important role in protection of end organs that are susceptible for secondary injury by the Traumatic brain injury (TBI)-induced catecholamine surge. However, use of BBs in trauma patients is not yet the standard of care which necessitates clear scientific evidence and justification to be used especially in TBI patients. The BBTBBT study aims to determine whether early administration of propranolol based on the HSTnT status will improve the outcome of mild-to-severe TBI patients. Our primary hypothesis is that BBs are effective in reducing 10 and 30-day mortality in TBI patients.BBs are effective in reducing 10 and 30-day mortality in TBI patients.

Methods/Design: The BBTBBT study is a prospective, randomized, double-blinded, placebo-controlled trial, three-arm trial of BB use in mild-to-severe TBI patients based on the HsTnT status.

Conditions

  • Trauma
  • Brain Injuries
  • Stress Reaction
  • Beta Blockers
  • Troponin

Interventions

DRUG

Placebo

12 ampoules of 1 mg placebo solution (3 ampoules/day for 2 days; 2 ampoules/day for day-3 \& 4 and 1 ampoule/day for day-5 \& 6.

DRUG

Propranolol

12 ampoules of 1 mg placebo solution (3 ampoules/day for 2 days; 2 ampoules/day for day-3 \& 4 and 1 ampoule/day for day-5 \& 6.

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Ayman El-Menyar, MD · Hamad Medical Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-29
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Qatar

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508244 on ClinicalTrials.gov