Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Patients With Traumatic Brain Injury

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

Evaluate the effect of tranexamic acid on mortality in pediatric patients with traumatic brain injury. This could potentially lead to improved treatment protocols and better outcomes for this vulnerable population.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age Less than 18 years old
  2. Clinical diagnose of trauma to the Head and GCS score less than or equal to 13 withassociated intracranial haemorrhage on cranial CT scan
  3. Time of admission within 3 hour of injury.

Exclusion

Exclusion Criteria:

  1. Patient Known pregnancy.
  2. patient had Cardiac arrest prior to randomization
  3. GCS score of 3 with bilateral unresponsive pupils
  4. Known bleeding/clotting disorders.
  5. Known seizure disorders.
  6. Known history of severe renal impairment
  7. Unknown time of injury
  8. Prior TXA for current injury
  9. 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,
    Egypt

    Active - Recruiting

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