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Pre-hospital Administration of Tranexamic Acid for Moderate and Severe Traumatic Brain Injury

NCT02645552 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2016-01-01

No results posted yet for this study

Summary

This study is a prospective single-centre randomized trial to compare the effect of tranexamic acid versus placebo in the pre-hospital management of patients with moderate and severe traumatic brain injury.

Conditions

  • Brain Injuries, Traumatic

Interventions

DRUG

Tranexamic Acid

Tranexamic acid 1 gram in 100 ml saline, by intravenous drip over 10 minutes, once patient admitted to the trial on the spot of TBI

OTHER

Sodium chloride

Sodium Chloride solution (0.9%) 1 ml (gram) in 100 ml saline, by intravenous drip over 10 minutes, once patient admitted to the trial on the spot of TBI

Sponsors & Collaborators

  • Shanghai Pudong Emergency Center

    collaborator UNKNOWN

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Guoyi Gao, MD, PhD · Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-12-31
Completion
2018-06-30

Countries

  • China

Study Locations

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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 NCT02645552 on ClinicalTrials.gov