Clinical trial NCT06097611: Tranexamic Acid Effect in Pediatric
Official title: Efficacy and Outcome of Early Administration of Tranexamic Acid in Pediatric Polytraumatized Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Tranexamic Acid Effect in Pediatric Polytraumatized Patients
Keywords: Tranexamic Acid
Effect
Polytrauma
Pediatric
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 74
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the mortality rate among polytraumatic pediatrics who received Tranexamic acid within 3 hours versus those who did not received
timeFrame: 1 yaer
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: