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Clinical trial

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

ID
Name
192-2023
Description
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.
Trial arms
Trial start
2024-03-25
Estimated PCD
2025-03-01
Trial end
2025-03-01
Status
Recruiting
Phase
Early phase I
Treatment
Tranexamic Acid (TXA)
30 patients will be randomized to A arm and 30 patients to B arm
Arms:
TXA dose A arm, TXA dose B arm
Other names:
TXA dose A arm &TXA dose B arm
Normal saline
30 patients will be randomized this arm C
Arms:
Placebo arm C
Other names:
Placebo arm C
Size
90
Primary endpoint
The early traumatic brain injury-related death in the hospital
24 hour and 48 hour after injury
The difference between treatment group in the Intracranial haemorrhage growth
24 hour
The difference between the treatment groups in the incidence of mortality
28 days
Eligibility criteria
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 with associated intracranial haemorrhage on cranial CT scan 3. Time of admission within 3 hour of injury. 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2024-05-10

1 organization

1 product

1 drug

1 indication

Organization
Mansoura University
Product
Tranexamic Acid
Indication
Traumatic Brain Injury
Drug
Varlilumab