Efficacy of Tranexamic Acid Reducing Blood Loss During Maxillofacial Trauma Surgery

Nishtar Medical University

Status and phase: Completed; Phase 2

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

Treatments: Drug: Normal saline; Drug: Tranexamic Acid (TXA)

Study type: Interventional

Funder types: Other

Identifiers

NCT07392034

12076/NID

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Trenexamic acid group

Active Comparator group

Description:

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

Treatment:

Drug: Tranexamic Acid (TXA)

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline