Traumatic Brain InjuryPhase 1/2NCT06330935
Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Patients With Traumatic Brain Injury
A Phase 1/2 study testing Tranexamic Acid (TXA) and Normal saline in people with Traumatic Brain Injury, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Tranexamic Acid (TXA) and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2024to Mar 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Unknown time of injury
- Prior TXA for current injury
- Known venous or arterial thrombosis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University Hospital in New Damietta
Damietta
Adel Diab, professor
About this study
Official title: 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Tranexamic Acid (TXA), Normal saline
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (TXA)Drug
Also called TXA dose A arm &TXA dose B arm
30 patients will be randomized to A arm and 30 patients to B arm
Normal salineDrug
Also called Placebo arm C
30 patients will be randomized this arm C
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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) Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The early traumatic brain injury-related death in the hospital
- Decreasing the rate of early head injury-related death (within 24 hour after injury)
Measured: 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
Measured: 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)
Measured: 28 days
Secondary outcomes (6)
Need for neurosurgical management
Evacuation of acute subdural hematoma,Evacuation of epidural hematoma and Evacuation of traumatic intracerebral hematoma (contusions)
Measured: 28 day
Days in the intensive care unit
Decreasing days in intensive care unit within 28 day of injury
Measured: 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.
Measured: 48 hour
Adverse events
Decreasing incidence of seizures, complications and other adverse events
Measured: 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.
Measured: 6 months
Pediatric Glasgow Outcome Scale Extended (GOS-E) Peds)
Improving the Pediatric Glasgow Outcome Scale Extended (GOS-E Peds) scores
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start25 Mar 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mansour, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330935
- Sponsor's protocol ID
- 192-2023
- Status last verified
- May 2024
- First submitted
- 18 Feb 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Pediatric Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06330935
- Acronym / sponsor ID
- 192-2023
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TXA dose A arm | Active comparator | Drug: Tranexamic Acid (TXA)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 |
| TXA dose B arm | Active comparator | Drug: Tranexamic Acid (TXA)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 |
| Placebo arm C | Placebo comparator | Drug: Normal salineSubjects 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) |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid (TXA)Also: TXA dose A arm &TXA dose B arm30 patients will be randomized to A arm and 30 patients to B arm | Drug | TXA dose A arm, TXA dose B arm |
| Normal salineAlso: Placebo arm C30 patients will be randomized this arm C | Drug | Placebo arm C |
Primary outcome
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)
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
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)
6 secondary outcomes
Need for neurosurgical management
Time frame: 28 day
Days in the intensive care unit
Time frame: 28 day
Need for blood transfusion
Time frame: 48 hour
Adverse events
Time frame: 28 days
Pediatric Quality of Life (PedsQL)
Time frame: 6 months
Pediatric Glasgow Outcome Scale Extended (GOS-E) Peds)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tranexamic Acid (TXA) and Normal saline in people with Traumatic Brain Injury, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Shams, Professor (201556300563, hamspharma@gmail.comms), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The early traumatic brain injury-related death in the hospital (time frame: 24 hour and 48 hour after injury). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.