RecruitingPhase 1Phase 2NCT06330935

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

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


Sponsor

Mansoura University

Enrollment

90 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 MonthMax Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria9

  • 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

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Interventions

DRUGTranexamic Acid (TXA)

30 patients will be randomized to A arm and 30 patients to B arm

DRUGNormal saline

30 patients will be randomized this arm C


Locations(1)

Al-Azhar University Hospital in New Damietta

Damietta, Egypt

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NCT06330935


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