Tranexamic Acid Effect in Pediatric Polytraumatized PatientsEarly Phase 1NCT06097611
Tranexamic Acid Effect in Pediatric
A Early Phase 1 study testing Tranexamic Acid administration in people with Tranexamic Acid Effect in Pediatric Polytraumatized Patients, run by Assiut University.
Trial summary
The study will compare mortality and blood transfusion amounts among severely polytraumatized pediatrics who did or did not receive tranexamic acid within 3 h of injury, based on Injury Severity Score (ISS) and indicators of coagulopathy and fibrinolysis. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Tranexamic Acid Effect in Pediatric Polytraumatized Patients
- What is being tested?
- Tranexamic Acid administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Dec 2024
- Phase
- Early Phase 1
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ISS ≥ 16
- age 2-18 years
- both genders
- polytraum a
Who cannot join
- age < 2 OR >18 years
- period from injury to admission >6 hours
- ISS<16
- comorbidity with bleeding disorder, malignancy.
- Patients receiving anticoagulant drugs.
Trial locations and contacts
No sites are listed yet.
Gehan Ahmed Sayed contact
About this study
Official title: Efficacy and Outcome of Early Administration of Tranexamic Acid in Pediatric Polytraumatized Patients
The study will compare mortality and blood transfusion amounts among severely polytraumatized pediatrics who did or did not receive tranexamic acid within 3 h of injury, based on Injury Severity Score (ISS) and indicators of coagulopathy and fibrinolysis.
Read the detailed description
Trauma is a leading cause of mortality in the pediatric population. In 2008, the American Academy of Pediatrics noted that trauma accounts for more deaths than all other causes combined . Bleeding remains the most preventable cause of death after trauma. A major recent advance was the recognition that coagulation defects are greatly responsible for the disproportional mortality caused by bleeding. Managing coagulation defects has become a forefront issue in trauma and novel strategies proposed include hemostatic resuscitation, adoption of massive transfusion protocols and other innovations , most with little evidence to support them. The exception is the proposal to administer tranexamic acid (TXA) to bleeding adult trauma patients.
To date, no medical treatment has been shown to reduce mortality in the setting of pediatric trauma; however, this evidence does exist in adults. Bleeding and coagulopathy due to trauma are associated with mortality in both adults and children. Clinical research has demonstrated a reduction in trauma-related mortality with early use of TXA in adult patients in both civilian and military settings . In adult patients with hemodynamic instability and ongoing bleeding, TXA is expected to save 1 in 67 lives . There is no scientific or biological reason to suggest that a similar mortality benefit will not be seen in pediatric trauma. The investigators feel the incorporation of TXA into pediatric trauma management has the potential to also significantly reduce mortality in children and youths, without increasing adverse events. This review explores the hematologic differences and similarities between injured children and adults, and the idea that TXA may be a novel and promising treatment in pediatric hemorrhagic trauma despite the current lack of evidence for its use in this setting.
TXA is an antifibrinolytic that reversibly binds to plasminogen at the lysine binding site, thus preventing the binding of plasmin (ogen) to fibrin and the subsequent degradation of fibrin . It is a generic, inexpensive medication used to prevent fibrin breakdown and reduce bleeding in various clinical settings (including orthopedic and cardiovascular surgery, post-partum hemorrhage, gastrointestinal hemorrhage, epistaxis, certain ophthalmologic conditions and other obstetric/gynecologic emergencies)
- Being tested
- Tranexamic Acid administration
- Keywords
- Tranexamic Acid, Effect, Polytrauma, Pediatric
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid administrationDrug
Tranexamic Acid administration to compare mortality and blood transfusion amounts among severely polytraumatized pediatrics who did or did not receive tranexamic acid within 3 h of injury
| Study group | Role | What they receive |
|---|---|---|
| Efficacy of early Tranexamic Acid in Pediatric Polytraumatized Patients | Experimental | Not described Receives: Drug: Tranexamic Acid administration |
| Efficacy of Early Tranexamic Acid in Pediatric Polytraumatized Patients | Active comparator | Not described Receives: Drug: Tranexamic Acid administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the mortality rate among polytraumatic pediatrics who received Tranexamic acid within 3 hours versus those who did not received
Measured: 1 yaer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tranexamic Acid Effect in Pediatric Polytraumatized PatientsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaaban Hassan Hassan Salim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097611
- Sponsor's protocol ID
- Tranexamic Acid Effect
- Status last verified
- Nov 2023
- First submitted
- 19 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Outcome of Early Administration of Tranexamic Acid in Pediatric Polytraumatized Patients
- ClinicalTrials.gov ID
- NCT06097611
- Acronym / sponsor ID
- Tranexamic Acid Effect
- Keywords
- Tranexamic Acid, Effect, Polytrauma, Pediatric
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Oct 2023 (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.
The study will compare mortality and blood transfusion amounts among severely polytraumatized pediatrics who did or did not receive tranexamic acid within 3 h of injury, based on Injury Severity Score (ISS) and indicators of coagulopathy and fibrinolysis.
Detailed description
Trauma is a leading cause of mortality in the pediatric population. In 2008, the American Academy of Pediatrics noted that trauma accounts for more deaths than all other causes combined . Bleeding remains the most preventable cause of death after trauma. A major recent advance was the recognition that coagulation defects are greatly responsible for the disproportional mortality caused by bleeding. Managing coagulation defects has become a forefront issue in trauma and novel strategies proposed include hemostatic resuscitation, adoption of massive transfusion protocols and other innovations , most with little evidence to support them. The exception is the proposal to administer tranexamic acid (TXA) to bleeding adult trauma patients.
To date, no medical treatment has been shown to reduce mortality in the setting of pediatric trauma; however, this evidence does exist in adults. Bleeding and coagulopathy due to trauma are associated with mortality in both adults and children. Clinical research has demonstrated a reduction in trauma-related mortality with early use of TXA in adult patients in both civilian and military settings . In adult patients with hemodynamic instability and ongoing bleeding, TXA is expected to save 1 in 67 lives . There is no scientific or biological reason to suggest that a similar mortality benefit will not be seen in pediatric trauma. The investigators feel the incorporation of TXA into pediatric trauma management has the potential to also significantly reduce mortality in children and youths, without increasing adverse events. This review explores the hematologic differences and similarities between injured children and adults, and the idea that TXA may be a novel and promising treatment in pediatric hemorrhagic trauma despite the current lack of evidence for its use in this setting.
TXA is an antifibrinolytic that reversibly binds to plasminogen at the lysine binding site, thus preventing the binding of plasmin (ogen) to fibrin and the subsequent degradation of fibrin . It is a generic, inexpensive medication used to prevent fibrin breakdown and reduce bleeding in various clinical settings (including orthopedic and cardiovascular surgery, post-partum hemorrhage, gastrointestinal hemorrhage, epistaxis, certain ophthalmologic conditions and other obstetric/gynecologic emergencies)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efficacy of early Tranexamic Acid in Pediatric Polytraumatized Patients | Experimental | Drug: Tranexamic Acid administration |
| Efficacy of Early Tranexamic Acid in Pediatric Polytraumatized Patients | Active comparator | Drug: Tranexamic Acid administration |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- ISS ≥ 16
- age 2-18 years
- both genders
- polytraum a
Key exclusion criteria (5 listed)
- age < 2 OR >18 years
- period from injury to admission >6 hours
- ISS<16
- comorbidity with bleeding disorder, malignancy.
- Patients receiving anticoagulant drugs.
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 administrationTranexamic Acid administration to compare mortality and blood transfusion amounts among severely polytraumatized pediatrics who did or did not receive tranexamic acid within 3 h of injury | Drug | Efficacy of Early Tranexamic Acid in Pediatric Polytraumatized Patients, Efficacy of early Tranexamic Acid in Pediatric Polytraumatized Patients |
Primary outcome
Determine the mortality rate among polytraumatic pediatrics who received Tranexamic acid within 3 hours versus those who did not received
Time frame: 1 yaer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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.
Gehan Ahmed Sayed contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tranexamic Acid administration in people with Tranexamic Acid Effect in Pediatric Polytraumatized Patients, run by Assiut University.
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 4 inclusion and 5 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 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Shaaban Hassan Hassan (0 101 241 6424, shaabansalim333@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the mortality rate among polytraumatic pediatrics who received Tranexamic acid within 3 hours versus those who did not received (time frame: 1 yaer). 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 3 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.