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

Intraoperative Bleeding Clinical Trial

— TXA2014-15  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229292
• Other study ID #: 2013-005473-52
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2014
• Last updated: March 9, 2017
• Start date: August 19, 2014
• Est. completion date: September 26, 2016

Study information

• Verified date: March 2017
• Source: Hospital of South West Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 26, 2016
• Est. primary completion date: September 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Intraoperative Bleeding
• Postoperative Edema

Intervention

Drug:
• Tranexamic Acid
Active group: Undergoes elective bi-maxillary orthognathic surgery consisting of a (un)/segmented LeFort I osteotomy combined with a bilateral sagittal split osteotomy, under the influence of 10ml tranexamic acid (100mg/ml) administered iv. prior to the onset of the surgical procedure.
• Saline
Placebo group: Undergoes elective bi-maxillary orthognathic surgery consisting of a (un)/segmented LeFort I osteotomy combined with a bilateral sagittal split osteotomy, under the influence of 10ml sodium chloride (9mg/ml) administered iv. prior to the onset of the surgical procedure.

Locations

Country	Name	City	State
Denmark	Hospital of South West Denmark	Esbjerg

Sponsors (3)

Lead Sponsor	Collaborator
Hospital of South West Denmark	University of Copenhagen, Vestjydsk Ortopædisk Fond

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-operative bleeding volume (ml)		Within 10 minutes after ended surgery
Secondary	Change in hemostatic profile	Changes in the hemostatic profile measured through thrombelastography, thrombin generation test and fibrin structure analysis.	Baseline, 5.5 hours, 48 hours and 4 months postoperatively
Secondary	Change in inflammatory profile	Changes in the inflammatory profile are investigated through measures of surface induced activation, inflammation and plasminogen binding.	Baseline, 5.5 hours, 48 hours and 4 months postoperatively
Secondary	Postoperative edema formation	The degree of postoperative swelling in connection with TXA /or not, is determined by non-invasive 3D face scans and quantified using the "Landmarker" software. Scans are carried out along with the 3rd and 4th blood samples, 48 hours and 4 months postoperatively.	48 hours and 4 months postoperatively

External Links

•   Link to the official site of the maxillofacial surgical department where the study takes place