Overview

This trial is active, not recruiting.

Conditions intraoperative bleeding, postoperative edema
Treatments tranexamic acid, saline
Phase phase 4
Sponsor Hospital of South West Denmark
Collaborator University of Copenhagen
Start date August 2014
End date November 2016
Trial size 100 participants
Trial identifier NCT02229292, 2013-005473-52

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
The active comparator consists of an intravenously administered bolus injection of 10ml of 100mg/ml tranexamic (1g in total) given as a single dose, after the onset of anesthesia, prior to surgery.
tranexamic acid Tranexamsyre "Pfizer", D.SP.NR.: 22646, ATC code: B 02 AA 02
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.
(Placebo Comparator)
The placebo consists of an intravenously administered bolus injection of 10 ml of 9mg/ml sodium chloride given as a single dose after the onset of anesthesia, prior to surgery.
saline Natriumklorid "B. Braun", D.SP.NR.: 6856, ATC code: V 07 AB
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.

Primary Outcomes

Measure
Intra-operative bleeding volume (ml)
time frame: Within 10 minutes after ended surgery

Secondary Outcomes

Measure
Change in hemostatic profile
time frame: Baseline, 5.5 hours, 48 hours and 4 months postoperatively
Change in inflammatory profile
time frame: Baseline, 5.5 hours, 48 hours and 4 months postoperatively
Postoperative edema formation
time frame: 48 hours and 4 months postoperatively

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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.
Principal investigator Jesper J Olsen, DDS
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hospital of South West Denmark.