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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06330935
• Other study ID #: 192-2023
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 25, 2024
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Mansoura University
• Contact: Mohamed Shams, Professor
• Phone: 201556300563
• Email: hamspharma[@]gmail.comms
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Drug:
• Tranexamic Acid (TXA)
30 patients will be randomized to A arm and 30 patients to B arm
• Normal saline
30 patients will be randomized this arm C

Locations

Country	Name	City	State
Egypt	Al-Azhar University Hospital in New Damietta	Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	24 hour and 48 hour after injury
Primary	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	24 hour
Primary	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)	28 days
Secondary	Need for neurosurgical management	Evacuation of acute subdural hematoma,Evacuation of epidural hematoma and Evacuation of traumatic intracerebral hematoma (contusions)	28 day
Secondary	Days in the intensive care unit	Decreasing days in intensive care unit within 28 day of injury	28 day
Secondary	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.	48 hour
Secondary	Adverse events	Decreasing incidence of seizures, complications and other adverse events	28 days
Secondary	Pediatric Quality of Life (PedsQL)	Improving the Paediatric Quality of Life (PedsQL) . The PedsQL is a continuous score that ranges from 0-100.	6 months
Secondary	Pediatric Glasgow Outcome Scale Extended (GOS-E) Peds)	Improving the Pediatric Glasgow Outcome Scale Extended (GOS-E Peds) scores	6 months