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

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ClinicalTrials.gov Identifier: NCT02229292
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : March 10, 2017
Sponsor:
Collaborators:
University of Copenhagen
Vestjydsk Ortopædisk Fond
Information provided by (Responsible Party):
Jesper Jared Olsen, Hospital of South West Denmark

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


Condition or disease Intervention/treatment Phase
Intraoperative Bleeding Postoperative Edema Drug: Tranexamic Acid Drug: Saline Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : August 19, 2014
Actual Primary Completion Date : September 26, 2016
Actual Study Completion Date : September 26, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Edema

Arm Intervention/treatment
Active Comparator: Tranexamic acid
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.
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.

Other Name: Tranexamsyre "Pfizer", D.SP.NR.: 22646, ATC code: B 02 AA 02

Placebo Comparator: Saline
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.
Drug: 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.

Other Name: Natriumklorid "B. Braun", D.SP.NR.: 6856, ATC code: V 07 AB




Primary Outcome Measures :
  1. Intra-operative bleeding volume (ml) [ Time Frame: Within 10 minutes after ended surgery ]

Secondary Outcome Measures :
  1. Change in hemostatic profile [ Time Frame: Baseline, 5.5 hours, 48 hours and 4 months postoperatively ]
    Changes in the hemostatic profile measured through thrombelastography, thrombin generation test and fibrin structure analysis.

  2. Change in inflammatory profile [ Time Frame: Baseline, 5.5 hours, 48 hours and 4 months postoperatively ]
    Changes in the inflammatory profile are investigated through measures of surface induced activation, inflammation and plasminogen binding.

  3. Postoperative edema formation [ Time Frame: 48 hours and 4 months postoperatively ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229292


Locations
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Denmark
Hospital of South West Denmark
Esbjerg, Denmark, 6700
Sponsors and Collaborators
Hospital of South West Denmark
University of Copenhagen
Vestjydsk Ortopædisk Fond
Investigators
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Principal Investigator: Jesper J Olsen, DDS Hospital of South West Denmark

Additional Information:
Publications:
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Responsible Party: Jesper Jared Olsen, DDS, Hospital of South West Denmark
ClinicalTrials.gov Identifier: NCT02229292     History of Changes
Other Study ID Numbers: 2013-005473-52
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants