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

NCT06330935 | Recruiting Phase 1

• 1 other identifier: 192-2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Need for neurosurgical management

  28 day

• Days in the intensive care unit

  28 day

• Need for blood transfusion

  48 hour

• Adverse events

  28 days

• Pediatric Quality of Life (PedsQL)

  6 months

Study Arms (3)

TXA dose A arm

ACTIVE COMPARATOR

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)

TXA dose B arm

ACTIVE COMPARATOR

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)

Placebo arm C

PLACEBO COMPARATOR

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

Interventions

Tranexamic Acid (TXA) DRUG

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

Also known as: TXA dose A arm &TXA dose B arm

TXA dose A arm; TXA dose B arm

Normal saline DRUG

30 patients will be randomized this arm C

Also known as: Placebo arm C

Placebo arm C

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age Less than 18 years old
• Clinical diagnose of trauma to the Head and GCS score less than or equal to 13 with associated intracranial haemorrhage on cranial CT scan
• Time of admission within 3 hour of injury.

You may not qualify if:

• Patient Known pregnancy.
• patient had Cardiac arrest prior to randomization
• GCS score of 3 with bilateral unresponsive pupils
• Known bleeding/clotting disorders.
• Known seizure disorders.
• Known history of severe renal impairment
• Unknown time of injury
• Prior TXA for current injury
• Known venous or arterial thrombosis

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Al-Azhar University Hospital in New Damietta

Damietta, Egypt

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Mohamed Shams, Professor

CONTACT

201556300563; hamspharma@gmail.comms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy- Faculty of Pharmacy - Mansoura University

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 26, 2024
• Study Start: March 25, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)