Efficacy of Tranexamic Acid Reducing Blood Loss During Maxillofacial Trauma Surgery

February 2, 2026 updated by: Shakir Hussain, Nishtar Medical University
Tranexamic acid (TXA) is an inexpensive, easily used and relatively safe drug. It inhibits plasminogen activation and plasmin thus retards clot disintegration.Therapeutic application of tranexamic acid in trauma for preventing blood loss has been documented since long. Since blood loss causes several serious complications, it is compensated emergently by transfusion of blood or its products. However, transfusion of blood and products always carries a risk of inadvertent transmission of infection, antigen-antibody reactions and additional cost all of which can be prevented if blood loss is reduced. Morbidity associated with the delay in compensating the blood loss could also be prevented by pharmaceutically preventing hemorrhage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During management of maxillofacial injuries, hemostasis is essential to clear the airway also. It is reported that blood loss is the most common complication following maxillofacial fractures and their treatment.TXA oral rinse has been used for preventing excessive hemorrhage for patients with coagulopathies. IV TXA has also been proven to be effective in reducing bleeding in healthy adults undergoing third molar surgery. Administration of TXA has also been evaluated and found effective in reducing post-surgical hemorrhage during and after bimaxillary orthognathic surgery.

This study has been planned to evaluate how efficacious is preoperative tranexamic acid in decreasing blood loss while performing surgery in cases with maxillofacial trauma in our local setting. the study results will provide local evidence and will support the incorporation of safe and inexpensive drug i.e., TXA into trauma clinical practice guidelines and local treatment protocols.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Multan, Punjab Province, Pakistan, 66000
        • Nishtar institute of dentistry, Multan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • either gender.
  • presenting within seven days of trauma.
  • planned for maxillofacial surgery.

Exclusion Criteria:

  • Patients with international normalized ratio (INR) greater than 1.5.
  • American Society of Anesthesiologists (ASA) physical status of 3 or higher.
  • chronic kidney disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Trenexamic acid group
Thirty minutes prior to surgery, the intervention group received intravenous trenexamic acid at a dose of 20 mg/kg.
Drug: Tranexamic Acid (TXA)
Thirty minutes prior to surgery, the intervention group receive intravenous , single dose of tranexamic acid of 20 mg/kg.
Placebo Comparator: Placebo group
Thirty minutes prior to surgery, the placebo group received 20 mL of normal saline.
Drug: Normal saline
Thirty minutes prior to surgery, the placebo group received single dose of 20 mL of normal saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean intraoperative blood loss
Time Frame: Immediately at the end of surgery
mean intraoperative blood loss between patients receiving intravenous tranexamic acid and those receiving placebo during maxillofacial trauma surgery.
Immediately at the end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean drop in hemoglobin levels postoperatively
Time Frame: 03 hours after post operatively
To assess the mean drop in hemoglobin levels postoperatively between the TXA and placebo groups.
03 hours after post operatively
intraoperative blood transfusion
Time Frame: Preoperative
To evaluate the need for intraoperative blood transfusion between the two groups.
Preoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nishtar Medical University

Investigators

  • Study Director: Dr. Saima Munir, FCPS (OMFS), Nishtar institute of dentistry, Multan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Wong J, George RB, Hanley CM, Saliba C, Yee DA, Jerath A. Tranexamic acid: current use in obstetrics, major orthopedic, and trauma surgery. Can J Anaesth. 2021;68(6):894-917.
  • Ramirez RJ, Spinella PC, Bochicchio GV. Tranexamic Acid Update in Trauma. Crit Care Clin. 2017;33(1):85-99.
  • Patel PA, Wyrobek JA, Butwick AJ, Pivalizza EG, Hare GMT, Mazer CD, et al. Update on Applications and Limitations of Perioperative Tranexamic Acid. Anesth Analg. 2022;135(3):460-73.
  • Gruen RL, Mitra B, Bernard SA, McArthur CJ, Burns B, Gantner DC, et al. Prehospital Tranexamic Acid for Severe Trauma. N Engl J Med. 2023;389(2):127-36.
  • Colomina MJ, Contreras L, Guilabert P, Koo M, E MN, Sabate A. Clinical use of tranexamic acid: evidences and controversies. Braz J Anesthesiol. 2022;72(6):795-812.
  • Wu B, Lv K. Effect of tranexamic acid on postoperative blood loss. Br J Oral Maxillofac Surg. 2024;62(5):489-92.
  • Ockerman A, Vanassche T, Garip M, Vandenbriele C, Engelen MM, Martens J, et al. Tranexamic acid for the prevention and treatment of bleeding in surgery, trauma and bleeding disorders: a narrative review. Thromb J. 2021;19(1):54.
  • Khiabani K, Ahmadfar M, Labafchi A, Gosheh MR, Samieirad S. Is Preoperative Administration of Tranexamic Acid Effective on Blood Loss Reduction in Mandibular Fracture Surgeries? A Triple-Blind Randomized Clinical Trial. J Oral Maxillofac Surg. 2021;79(2):429.e1-.e7.
  • Dunphy L, Williams R. Immune thrombocytopenic purpura presenting with spontaneous gingival haemorrhage in pregnancy. BMJ Case Rep. 2019;12(1).
  • Chen MWJ, Yong CW, Lum JL. Use of an improvised clamp to manage bleeding tongue injuries. Am J Emerg Med. 2021;39:252.e1-.e2.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12076/NID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Duration of Surgery

Clinical Trials on Tranexamic Acid (TXA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe