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

NCT04494126 | Unknown Phase 4

• 1 other identifier: CMSNepal1
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blood Loss

Keywords

Maxillofacial trauma; blood loss

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss

  Measured and recorded from the anaesthesia patient chart

  Surgical period

Secondary Outcomes (1)

• Postoperative bleeding event

  upto 48 hours after surgery

Other Outcomes (1)

• Complications if any during surgery and upto 48 hours after surgery

  upto 48 hours after surgery

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

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.

Drug: Tranexamic acid

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Tranexamic acid DRUG

Drug: Tranexamic Acid Injectable Solution the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia before incision.

Also known as: Injection TXA 1 gram

Tranexamic acid

Placebo DRUG

Other: Placebo (normal saline 0.9%) An equivalent amount of normal saline (0.9%) will be given to the patient pre-operatively after induction of general anesthesia. The amount of saline given will correspond to the same amount of fluid which would have been given had the patient been in the intervention group.

Also known as: Normal saline

Placebo

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• College of Medical Sciences Teaching Hospital. Nepal: lead

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Rajesh Yadav, MD

  College of Medical Sciences Teaching hospital, Bharatpur, Nepal

  STUDY DIRECTOR

Central Study Contacts

Ashutosh K Singh, MDS

CONTACT

+9779855082369; dr.ashutosh@cmsnepel.edu.np

Ashutosh K Singh, MDS

CONTACT

+9779804244369; drashutoshkumarsingh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the anaesthesiologist who is administering the medications is unmasked until completion of the data collection period.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Randomized, double-blind, Parallel assignment

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: August 15, 2021
• Primary Completion: October 15, 2021
• Study Completion: December 15, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share