- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06330935
Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Patients With Traumatic Brain Injury
March 18, 2024 updated by: Noha Mansour, Mansoura University
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
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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
|
30 patients will be randomized to A arm and 30 patients to B arm
Other Names:
|
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
|
30 patients will be randomized to A arm and 30 patients to B arm
Other Names:
|
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)
|
30 patients will be randomized this arm C
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The early traumatic brain injury-related death in the hospital
Time Frame: 24 hour and 48 hour after injury
|
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
Time Frame: 24 hour
|
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
Time Frame: 28 days
|
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
Time Frame: 28 day
|
Evacuation of acute subdural hematoma,Evacuation of epidural hematoma and Evacuation of traumatic intracerebral hematoma (contusions)
|
28 day
|
Days in the intensive care unit
Time Frame: 28 day
|
Decreasing days in intensive care unit within 28 day of injury
|
28 day
|
Need for blood transfusion
Time Frame: 48 hour
|
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
Time Frame: 28 days
|
Decreasing incidence of seizures, complications and other adverse events
|
28 days
|
Pediatric Quality of Life (PedsQL)
Time Frame: 6 months
|
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)
Time Frame: 6 months
|
Improving the Pediatric Glasgow Outcome Scale Extended (GOS-E Peds) scores
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 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)
March 26, 2024
Last Update Submitted That Met QC Criteria
March 18, 2024
Last Verified
March 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Perception Dynamics InstituteUniversity of California, San Diego; University of South Alabama; University...RecruitingMTBI - Mild Traumatic Brain InjuryUnited States
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