Status:
COMPLETED
Evaluation of the Safety and Efficacy of the Second Dose of Tranexamic Acid
Lead Sponsor:
Hamad Medical Corporation
Conditions:
Tranexamic Acid
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
TXA is currently administered pre-hospital in Canada, Germany, United Kingdom and Israel . These studies demonstrated that TXA use did not result in any detectable complications or adverse events. It ...
Detailed Description
Study design It is a single-center, prospective, double-blind, randomized, placebo-controlled trial. Study population All severely injured male and female patients with evidence of significant hemorr...
Eligibility Criteria
Inclusion
- All adult trauma male and female patients (≥18 or \<90 years) with evidence of significant hemorrhage (systolic blood pressure \<90 mmHg or heart rate \>110 beats per minutes, or both) or had Capillary Refill Time 3-4 seconds \[2\] and received first dose of prehospital TXA will be included in the study.
Exclusion
- Age \> 90 or \< 18 years of age
- Inability to obtain intravenous access (intraosseous access not sufficient)
- Documented cervical cord injury with motor deficit
- Known prisoner
- Known pregnancy
- Traumatic arrest with \> 5 minutes CPR without return of vital signs
- Penetrating cranial injury
- Traumatic brain injury with brain matter exposed
- Isolated drowning or hanging victims
- Wearing an opt out bracelet.
Key Trial Info
Start Date :
December 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2021
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03846973
Start Date
December 2 2018
End Date
February 10 2021
Last Update
February 11 2021
Active Locations (1)
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1
Hamad General Hospital
Doha, Qatar