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

College of Medical Sciences Teaching Hospital. Nepal

Status and phase: Unknown; Phase 4

Conditions: Blood Loss

Treatments: Drug: Placebo; Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04494126

CMSNepal1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Tranexamic acid

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic acid

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo