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NCT Number: NCT02229292

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

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

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Key information

Conditions

Intraoperative Bleeding Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital of South West Denmark

Esbjerg, 6700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tranexamic Acid

Drug

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

Saline

Drug

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

Primary outcomes

  1. Intra-operative bleeding volume (ml)

    Time frame: Within 10 minutes after ended surgery

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Collaborators

  • University of Copenhagen
  • Vestjydsk Ortopædisk Fond

Registry information

Official study title

Prevention of Bleeding and Edema in Bimaxillary Orthognathic Surgery; the Effectiveness of Tranexamic Acid on Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery.

Acronym: TXA2014-15

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 1, 2014
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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