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

Launched by ESBJERG HOSPITAL - UNIVERSITY HOSPITAL OF SOUTHERN DENMARK · Aug 28, 2014

Keywords

ClinConnect Summary

The study population consists of patients referred to simultaneous mandibular and maxillary osteotomy at the Department of Oral and Maxillofacial Surgery, Hospital of South West Denmark in 2014.

Hundred patients (50 men and 50 women) will be enrolled in the study. Reportedly, the mean intraoperative blood loss in the placebo group is expected to be 436 ml with a standard deviation of 208 ml. The difference in blood loss between the TXA-group and the placebo group to be detected is 100 ml. The dropout frequency is estimated to 10%. To fulfil these assumptions a minimum of 40 patients should...

Gender

ALL

Eligibility 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)