Prevention of bleeding and edema in bi-maxillary orthognathic surgery; the effectiveness of tranexamic acid on intraoperative bleeding in orthognathic surgery

Phase 1

• Conditions: Surgical bleeding during bi-maxillary orthognathic surgery; MedDRA version: 18.0Level: LLTClassification code 10051536Term: Intraoperative bleedingSystem Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2013-005473-52-DK
• Lead Sponsor: Hospital of South West Jutland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-06
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients must be healthy, 18 years or older, and present with no known medical conditions incl. significantly reduced renal function. All patients must be sceduled for routine orthognathic surgery at the department of maxillofacial surgery at the hospital of South West Jutland.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients must not present with sensitivity to tranexamic acid, acute venous/arterial thrombosis, fibrinolytic conditions due to disseminated intravascular coagulation, except for instances of predominant activation of the fibrinolytic system in regards to acute severe bleeding. Severe reduced renal function, medical history reporting cramps. Intake of Omega 3 fatty acids, Gingko Biloba, ginger and garlic dietary supplements <10 days prior to surgery. Pregnancy (will be tested for on the day of surgery via urine test).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified