Prevention of Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery Through the Use of Tranexamic Acid

• Status: Completed
• Trial end date: 2016-09-26
• Target enrollment: 0
• Participant gender: All

Summary

Purpose of the study:

• To evaluate the effect of tranexamic acid (TXA) of intraoperative blood loss in patients subjected to bi-maxillary orthognathic surgery

• To evaluate the potential effect of TXA on fibrin structure

• To evaluate the potential effect of TXA of binding of plasminogen to fibrin

• To evaluate the potential effect of TXA on postoperative edema formation.

Hypothesis:

H0: Intraoperative bleeding cannot be significantly reduced by preoperative administration of tranexamic acid

H0,1: Postoperative edema cannot be significantly reduced by preoperative administration of tranexamic acid

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital of South West Denmark
• Collaborators: University of Copenhagen; Vestjydsk Ortopædisk Fond
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Patients must be 18 years or older

• Patients must be eligible for elective bi-maxillary orthognathic surgery

• No severe reduction of kidney function

• No known medical conditions

• Signed informed consent

Exclusion Criteria:

• Hypersensitivity to tranexamic acid

• A medical history of acute venous thrombosis and/or arterial thrombosis

• The presence of fibrinolytic conditions as a result of disseminated intravascular coagulation, with the exception of a predominant activation of the fibrinolytic system with acute severe bleeding.

• Severe kidney deficiency

• Cramps in the medical history

• Intake of Omega-3 fatty acids, Gingko Biloba, ginger and garlic supplements within 3 months of surgery.

• Pregnancy (female participants will be tested on the day of surgery)