Tranexamic Acid Effect in Pediatric

NCT ID: NCT06097611

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2024-12-31

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)

Conditions

Tranexamic Acid Effect in Pediatric Polytraumatized Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Efficacy of early Tranexamic Acid in Pediatric Polytraumatized Patients

Group Type: EXPERIMENTAL

Tranexamic Acid administration

Intervention Type: DRUG

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

Efficacy of Early Tranexamic Acid in Pediatric Polytraumatized Patients

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid administration

Intervention Type: DRUG

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

Interventions

Tranexamic 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shaaban Hassan Hassan Salim

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Shaaban Hassan Hassan

Role: CONTACT

shaabansalim333@gmail.com

0 101 241 6424

Gehan Ahmed Sayed

Role: CONTACT

0 100 625 3939

Other Identifiers

Tranexamic Acid Effect

Identifier Type: -

Identifier Source: org_study_id