Clinical trial NCT02229292: Prevention of Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery Through the Use of Tranexamic Acid
Official title: Prevention of Bleeding and Edema in Bimaxillary Orthognathic Surgery; the Effectiveness of Tranexamic Acid on Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intraoperative Bleeding
Postoperative Edema
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Vestjydsk Ortopædisk Fond
First posted: 2014-09-01
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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

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.

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 be included in each group to reach a power of 0.8 and an alpha of 0.05. In order to accommodate an even gender distribution a block randomization is performed resulting in the randomization of 100 patients.

The patients will be randomized to receive blindly either 10 ml tranexamic acid (100 mg/ml) (Pfizer, Ballerup, Denmark) or 10 ml saline (9mg/ml) preoperatively. Intraoperative blood loss will be determined by deducting the total volume of irrigation fluids from the volume of the contents of the surgical suction device. Postoperative edema formation will be determined by 3D surface scanning and volumetric analysis will be carried out in the "Landmarker" software.

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)

Primary outcomes:
measure: Intra-operative bleeding volume (ml)
timeFrame: Within 10 minutes after ended surgery
Secondary outcomes:
measure: Change in hemostatic profile
timeFrame: Baseline, 5.5 hours, 48 hours and 4 months postoperatively
measure: Change in inflammatory profile
timeFrame: Baseline, 5.5 hours, 48 hours and 4 months postoperatively
measure: Postoperative edema formation
timeFrame: 48 hours and 4 months postoperatively
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Hospital of South West Denmark
Study officials:
affiliation: Esbjerg Hospital - University Hospital of Southern Denmark
name: Jesper J Olsen, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song G, Yang P, Hu J, Zhu S, Li Y, Wang Q. The effect of tranexamic acid on blood loss in orthognathic surgery: a meta-analysis of randomized controlled trials. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 May;115(5):595-600. doi: 10.1016/j.oooo.2012.09.085. Epub 2012 Dec 20.