Tranexamic Acid Effect in Pediatric

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tranexamic Acid Effect in Pediatric Polytraumatized Patients
• Intervention / Treatment: Drug: Tranexamic Acid administration

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 Type: Interventional
• Enrollment (Estimated): 74
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Shaaban Hassan Hassan; Phone Number: 0 101 241 6424; Email: shaabansalim333@gmail.com
• Study Contact Backup: Name: Gehan Ahmed Sayed; Phone Number: 0 100 625 3939

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Efficacy of early Tranexamic Acid in Pediatric Polytraumatized Patients	Drug: 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
Active Comparator: Efficacy of Early Tranexamic Acid in Pediatric Polytraumatized Patients	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the mortality rate among polytraumatic pediatrics who received Tranexamic acid within 3 hours versus those who did not received	1 yaer

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Pediatric; Effect; Tranexamic Acid; Polytrauma
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: Tranexamic Acid Effect

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No