Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma

Phase 4

• Conditions: Blood Loss
• Interventions: Drug: Tranexamic acid; Drug: Placebo

• Registration Number: NCT04494126
• Lead Sponsor: College of Medical Sciences Teaching Hospital. Nepal

Brief Summary

This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are objectively rated and complications are noted.

Detailed Description

This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is calculated from anaesthesia chart and recorded in ml. Postoperative ecchymosis and bleeding are recorded as dichotomous events (yes/no) and are subjectively rated by both patient and surgeon on postoperative days 1and 2. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-01
• Last Update Posted: 2021-08-03
• Study Start: 2021-08-15
• Primary Completion: 2021-10-15
• Study Completion: 2021-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients undergoing ORIF under GA for Maxillofacial fractures
• Patients between with ages of 16-65
• No cardiac comorbidities (hypertension, congenital heart malformation)
• No known coagulopathy
• No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants)
• ASA I and II patients

Exclusion Criteria

• Patients younger than 16 and older than 65
• Patients with known coagulopathy
• Patients with cardiac comorbidities
• Patients with a family history of bleeding disorders
• ASA III or higher

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Tranexamic acid	Experimental: TXA Group One gram of intravenous tranexamic acid (TXA) in normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period.
Placebo	Placebo	Placebo Comparator: Control Group Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period.

Primary Outcome Measures

Name	Time	Method
Intraoperative blood loss	Surgical period	Measured and recorded from the anaesthesia patient chart

Secondary Outcome Measures

Name	Time	Method
Postoperative bleeding event	upto 48 hours after surgery	postoperative bleeding and ecchymosis subjectively reported by patient and assessed by clinician, recorded as a dichotomous outcome.