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

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 Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Drug: Tranexamic Acid (TXA); Drug: Normal saline

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Mohamed Shams, Professor; Phone Number: 201556300563; Email: hamspharma@gmail.comms

Study Locations

• Egypt
  • Damietta, Egypt
    • Recruiting
    • Al-Azhar University Hospital in New Damietta
    • Contact: Adel Diab, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TXA dose A arm; 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	Drug: Tranexamic Acid (TXA); 30 patients will be randomized to A arm and 30 patients to B arm; Other Names: TXA dose A arm &TXA dose B arm
Active Comparator: TXA dose B arm; 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	Drug: Tranexamic Acid (TXA); 30 patients will be randomized to A arm and 30 patients to B arm; Other Names: TXA dose A arm &TXA dose B arm
Placebo Comparator: Placebo arm C; 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)	Drug: Normal saline; 30 patients will be randomized this arm C; Other Names: Placebo arm C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for neurosurgical management	Evacuation of acute subdural hematoma,Evacuation of epidural hematoma and Evacuation of traumatic intracerebral hematoma (contusions)	28 day
Days in the intensive care unit	Decreasing days in intensive care unit within 28 day of injury	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.	48 hour
Adverse events	Decreasing incidence of seizures, complications and other adverse events	28 days
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
Pediatric Glasgow Outcome Scale Extended (GOS-E) Peds)	Improving the Pediatric Glasgow Outcome Scale Extended (GOS-E Peds) scores	6 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 192-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No