Efficacy of Tranexamic Acid Reducing Blood Loss During Maxillofacial Trauma Surgery

NCT07392034 | Completed Phase 2

• 1 other identifier: 12076/NID
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemoglobin Level Measurement; Blood Loss During Surgery; Duration of Surgery

Keywords

Tranexamic acid; Oral and maxillofacial trauma surgery; Blood loss; Hemoglobin; Duration of surgery

Outcome Measures

Primary Outcomes (1)

• mean intraoperative blood loss

  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 Outcomes (2)

• mean drop in hemoglobin levels postoperatively

  03 hours after post operatively

• intraoperative blood transfusion

  Preoperative

Study Arms (2)

Trenexamic acid group

ACTIVE COMPARATOR

Thirty minutes prior to surgery, the intervention group received intravenous trenexamic acid at a dose of 20 mg/kg.

Drug: Tranexamic Acid (TXA)

Placebo group

PLACEBO COMPARATOR

Thirty minutes prior to surgery, the placebo group received 20 mL of normal saline.

Drug: Normal saline

Interventions

Tranexamic Acid (TXA) DRUG

Thirty minutes prior to surgery, the intervention group receive intravenous , single dose of tranexamic acid of 20 mg/kg.

Trenexamic acid group

Normal saline DRUG

Thirty minutes prior to surgery, the placebo group received single dose of 20 mL of normal saline.

Placebo group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar institute of dentistry, Multan

Multan, Punjab Province, 66000, Pakistan

Location

Related Publications (10)

• 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.

  BACKGROUND

• Ramirez RJ, Spinella PC, Bochicchio GV. Tranexamic Acid Update in Trauma. Crit Care Clin. 2017;33(1):85-99.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Wu B, Lv K. Effect of tranexamic acid on postoperative blood loss. Br J Oral Maxillofac Surg. 2024;62(5):489-92.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Dunphy L, Williams R. Immune thrombocytopenic purpura presenting with spontaneous gingival haemorrhage in pregnancy. BMJ Case Rep. 2019;12(1).

  BACKGROUND

• 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.

  BACKGROUND

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

• Dr. Saima Munir, FCPS (OMFS)

  Nishtar institute of dentistry, Multan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate resident Oral and maxillofacial surgery

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 6, 2026
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

PA (1)