Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Patients With Traumatic Brain Injury
NCT ID: NCT06330935
Last Updated: 2024-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2024-03-25
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Tranexamic Acid (TXA)
30 patients will be randomized to A arm and 30 patients to B arm
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
Tranexamic Acid (TXA)
30 patients will be randomized to A arm and 30 patients to B arm
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)
Normal saline
30 patients will be randomized this arm C
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
1 Month
18 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Noha Mansour
Lecturer of Clinical Pharmacy- Faculty of Pharmacy - Mansoura University
Locations
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Al-Azhar University Hospital in New Damietta
Damietta, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Adel Diab, professor
Role: primary
Other Identifiers
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192-2023
Identifier Type: -
Identifier Source: org_study_id
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