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Tranexamic Acid Effect in Pediatric

Efficacy and Outcome of Early Administration of Tranexamic Acid in Pediatric Polytraumatized Patients

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06097611
Enrollment
74
Registered
2023-10-24
Start date
2023-11-30
Completion date
2024-12-31
Last updated
2023-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tranexamic Acid Effect in Pediatric Polytraumatized Patients

Keywords

Tranexamic Acid, Effect, Polytrauma, Pediatric

Brief 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.

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)

Interventions

DRUGTranexamic Acid administration

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

1. ISS ≥ 16 2. age 2-18 years 3. both genders 4. polytraum a

Exclusion criteria

1. age \< 2 OR \>18 years 2. period from injury to admission \>6 hours 3. ISS\<16 4. comorbidity with bleeding disorder, malignancy. 5. Patients receiving anticoagulant drugs.

Design outcomes

Primary

MeasureTime frame
Determine the mortality rate among polytraumatic pediatrics who received Tranexamic acid within 3 hours versus those who did not received1 yaer

Contacts

Primary ContactShaaban Hassan Hassan
shaabansalim333@gmail.com0 101 241 6424
Backup ContactGehan Ahmed Sayed
0 100 625 3939

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026