Tranexamic Acid Effect in Pediatric

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06097611

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tranexamic Acid Effect in Pediatric Polytraumatized Patients	Drug: Tranexamic Acid administration	N/A

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. We 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

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Determine the mortality rate among polytraumatic pediatrics who received Tranexamic acid within 3 hours versus those who did not received [1 yaer]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ISS ≥ 16
age 2-18 years
both genders
polytraum a

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shaaban Hassan Hassan Salim, Resident, Assiut University

ClinicalTrials.gov Identifier:

NCT06097611

Other Study ID Numbers:

Tranexamic Acid Effect

First Posted:

Oct 24, 2023

Last Update Posted:

Oct 24, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tranexamic Acid

Study Results

No Results Posted as of Oct 24, 2023