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

Mansoura University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Traumatic Brain Injury

Treatments: Drug: Normal saline; Drug: Tranexamic Acid (TXA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06330935

192-2023

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups, including a placebo group

TXA dose A arm

Active Comparator group

Description:

Subjects will receive a 15 mg/kg bolus of Tranexamic acid over 20 minutes followed by 2 mg/kg/hr. infusion over 8 hours. The maximum bolus dose is 1000 mg, the maximum rate of infusion is 50 mg/min, and the maximum total maintenance dose is 1000 mg

Treatment:

Drug: Tranexamic Acid (TXA)

TXA dose B arm

Active Comparator group

Description:

Subjects will receive a 30 mg/kg bolus of Tranexamic acid over 20 minutes followed by 4 mg/kg/hr. infusion over 8 hours. The maximum bolus dose is 2000 mg, the maximum rate of infusion is 100 mg/min, and the maximum total maintenance dose is 2000 mg

Treatment:

Drug: Tranexamic Acid (TXA)

Placebo arm C

Placebo Comparator group

Description:

Subjects in the placebo group will receive a bolus dose of normal saline over 20 minutes followed by a normal saline infusion over 8 hours (in the same weight-based volume as the other study arms)

Treatment:

Drug: Normal saline