Last updated: May 9, 2024
Sponsor: Mansoura University
Overall Status: Active - Recruiting
Phase
1/2
Condition
Memory Loss
Traumatic Brain Injury
Neurologic Disorders
Treatment
Tranexamic Acid (TXA)
Normal saline
Clinical Study ID
NCT06330935
192-2023
Ages 1-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age Less than 18 years old
- Clinical diagnose of trauma to the Head and GCS score less than or equal to 13 withassociated intracranial haemorrhage on cranial CT scan
- Time of admission within 3 hour of injury.
Exclusion
Exclusion Criteria:
- Patient Known pregnancy.
- patient had Cardiac arrest prior to randomization
- GCS score of 3 with bilateral unresponsive pupils
- Known bleeding/clotting disorders.
- Known seizure disorders.
- Known history of severe renal impairment
- Unknown time of injury
- Prior TXA for current injury
- Known venous or arterial thrombosis
Study Design
Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Tranexamic Acid (TXA)
Phase: 1/2
Study Start date:
March 25, 2024
Estimated Completion Date:
March 31, 2025
Connect with a study center
Al-Azhar University Hospital in New Damietta
Damietta,
EgyptActive - Recruiting
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