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DASH After TBI Study: Decreasing Adrenergic or Sympathetic Hyperactivity After Traumatic Brain Injury

NCT01322048 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-08-17

Study results available
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Summary

The investigators intend to determine the effect of adrenergic blockade on 1) short-term physiology, behavior, and cognition and 2) long-term neuropsychological outcomes after severe Traumatic Brain Injury (TBI).

The primary hypothesis is that adrenergic blockade after severe TBI will be associated with increased ventilator-free days.

Conditions

Interventions

DRUG

IV Propranolol and Per Tube Clonidine

1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days

DRUG

Placebo

Placebo IV q6h and Per Tube q12, both for 7 days

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Eastern Association for the Surgery of Trauma (EAST)

    collaborator UNKNOWN

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Mayur B Patel, MD, MPH · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-01-31
Completion
2016-12-31
FDA Drug
Yes

Countries

  • United States

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 NCT01322048 on ClinicalTrials.gov