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

Phase 2RecruitingNCT06330935

Mansoura University90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Traumatic Brain Injury

Interventions

Tranexamic Acid (TXA)DRUG

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

Normal salineDRUG

30 patients will be randomized this arm C

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Al-Azhar University Hospital in New Damietta

Damietta, Egypt

RECRUITING

Outcomes

Primary Outcomes

The early traumatic brain injury-related death in the hospital

2\. Decreasing the rate of early head injury-related death (within 24 hour after injury)

Time frame: 24 hour and 48 hour after injury

The difference between treatment group in the Intracranial haemorrhage growth

We will measure intracranial hemorrhage progression at 24 hours in all subjects with intracranial hemorrhage on the initial clinical CT scan

Time frame: 24 hour

The difference between the treatment groups in the incidence of mortality

Decreasing the rate of head injury-related death in hospital within 28 days of injury all-cause and cause-specific mortality, disability, vascular occlusive events (myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism)

Time frame: 28 days

Secondary Outcomes

Need for neurosurgical management

Evacuation of acute subdural hematoma,Evacuation of epidural hematoma and Evacuation of traumatic intracerebral hematoma (contusions)

Time frame: 28 day

Days in the intensive care unit

Decreasing days in intensive care unit within 28 day of injury

Time frame: 28 day

Need for blood transfusion

Decreasing the total amount of blood products transfused in the initial 48 hours following randomization. Blood product transfusion volume will be measured at 24 hours, 48 hours. This will include volume of packed red blood cells, plasma, platelets, and cryoprecipitate in mL/kg.

Time frame: 48 hour

Adverse events

Central Contacts

Mohamed Shams, Professor

CONTACT

201556300563 hamspharma@gmail.comms

Data from ClinicalTrials.gov

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