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Prevention of Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery Through the Use of Tranexamic Acid (TXA2014-15)

Primary Purpose

Intraoperative Bleeding, Postoperative Edema

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Tranexamic Acid
Saline
Sponsored by
Hospital of South West Jutland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Hospital of South West Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic acid

Saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Intra-operative bleeding volume (ml)

Secondary Outcome Measures

Change in hemostatic profile
Changes in the hemostatic profile measured through thrombelastography, thrombin generation test and fibrin structure analysis.
Change in inflammatory profile
Changes in the inflammatory profile are investigated through measures of surface induced activation, inflammation and plasminogen binding.
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.

Full Information

First Posted
August 28, 2014
Last Updated
March 9, 2017
Sponsor
Hospital of South West Jutland
Collaborators
University of Copenhagen, Vestjydsk Ortopædisk Fond
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1. Study Identification

Unique Protocol Identification Number
NCT02229292
Brief Title
Prevention of Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery Through the Use of Tranexamic Acid
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 19, 2014 (undefined)
Primary Completion Date
September 26, 2016 (Actual)
Study Completion Date
September 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital of South West Jutland
Collaborators
University of Copenhagen, Vestjydsk Ortopædisk Fond

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Bleeding, Postoperative Edema

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Tranexamsyre "Pfizer", D.SP.NR.: 22646, ATC code: B 02 AA 02
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Natriumklorid "B. Braun", D.SP.NR.: 6856, ATC code: V 07 AB
Intervention Description
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 Outcome Measure Information:
Title
Intra-operative bleeding volume (ml)
Time Frame
Within 10 minutes after ended surgery
Secondary Outcome Measure Information:
Title
Change in hemostatic profile
Description
Changes in the hemostatic profile measured through thrombelastography, thrombin generation test and fibrin structure analysis.
Time Frame
Baseline, 5.5 hours, 48 hours and 4 months postoperatively
Title
Change in inflammatory profile
Description
Changes in the inflammatory profile are investigated through measures of surface induced activation, inflammation and plasminogen binding.
Time Frame
Baseline, 5.5 hours, 48 hours and 4 months postoperatively
Title
Postoperative edema formation
Description
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.
Time Frame
48 hours and 4 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper J Olsen, DDS
Organizational Affiliation
Hospital of South West Jutland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of South West Denmark
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23260768
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.
Results Reference
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Prevention of Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery Through the Use of Tranexamic Acid

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