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NCT Number: NCT07392034

Efficacy of Tranexamic Acid Reducing Blood Loss During Maxillofacial Trauma Surgery

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.

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Key information

Conditions

Hemoglobin Level Measurement Blood Loss During Surgery Duration of Surgery Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nishtar institute of dentistry, Multan

Multan, Punjab Province, 66000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic acid (TXA)

Drug

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

normal saline

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. intraoperative blood transfusion

    Time frame: Preoperative

    To evaluate the need for intraoperative blood transfusion between the two groups.

Sponsors and collaborators

Lead sponsor

Nishtar Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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