Status:
COMPLETED
Prevention of Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery Through the Use of Tranexamic Acid
Lead Sponsor:
Esbjerg Hospital - University Hospital of Southern Denmark
Collaborating Sponsors:
University of Copenhagen
Vestjydsk Ortopædisk Fond
Conditions:
Intraoperative Bleeding
Postoperative Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 T...
Detailed Description
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. Hund...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2016
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT02229292
Start Date
August 19 2014
End Date
September 26 2016
Last Update
March 10 2017
Active Locations (1)
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1
Hospital of South West Denmark
Esbjerg, Denmark, 6700