NCT07392034

Efficacy of Tranexamic Acid Reducing Blood Loss During Maxillofacial Trauma Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Nishtar Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Tranexamic Acid (TXA)	Thirty minutes prior to surgery, the intervention group receive intravenous , single dose of tranexamic acid of 20 mg/kg.
DRUG	Normal saline	Thirty minutes prior to surgery, the placebo group received single dose of 20 mL of normal saline.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: Pakistan