Surgical bleeding during bi-maxillary orthognathic surgery MedDRA version: 18.0 Level: LLT Classification code 10051536 Term: Intraoperative bleeding System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Pilexam
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tranexamic acid
Other descriptive name: TRANEXAMIC ACID
Concentration unit: mg/ml milligram(s)/millilitre
Concentra
Sponsors
Hospital of South West Jutland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must be healthy, 18 years or older, and present with no known medical conditions incl. significantly reduced renal function. All patients must be sceduled for routine orthognathic surgery at the department of maxillofacial surgery at the hospital of South West Jutland. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients must not present with sensitivity to tranexamic acid, acute venous/arterial thrombosis, fibrinolytic conditions due to disseminated intravascular coagulation, except for instances of predominant activation of the fibrinolytic system in regards to acute severe bleeding. Severe reduced renal function, medical history reporting cramps. Intake of Omega 3 fatty acids, Gingko Biloba, ginger and garlic dietary supplements <10 days prior to surgery. Pregnancy (will be tested for on the day of surgery via urine test).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is primarily to evaluate the effectiveness of tranexamic acid (TXA) on intraoperative blood loss - and secondarily postoperative swelling, in patients subjected to bi-maxillary orthognathic surgery. These surgical procedures are performed in anatomic areas rich in vessels, and intraoperative bleeding may pose a significant clinical problem. Tranexamic acid has been shown to significantly reduce intraoperative bleeding across the surgical fields, however within maxillofacial surgery few studies exist, and these are somewhat lacking in consistency and scope. Thus, the effect of TXA on intraoperative bleeding in patients subjected to simultaneous mandibular and maxillary osteotomy is uncertain and a carefully conducted, double-blinded, placebo controlled clinical study is needed.;Secondary Objective: The bleeding tendency during orthognathic surgery varies significantly and in an unpredictable way in this patient population which otherwise is rather homogeneous regarding age, body mass index, and health status, and the surgical procedures performed are similar. Thus it is sought to, secondarily: • 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 facial swelling.;Primary end point(s): Reduction of intraoperative bleeding by preoperative administration of tranexamic acid measured by volume of surgical blood loss in surgical suction device in milliliters. ;Timepoint(s) of evaluation of this end point: The blood loss is measured immediately (within minutes) after ended surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Blood samples will be collected during and after surgery: 1st sample is collected after the onset of anesthesia, before administration of tranexamic acid and start of surgery. This i usually around 8:00 AM. 2nd sample is collected 5 1/2 hours later. 3rd sample is collected 48 hours postoperatively. 4th sample is collected 4 months preoperatively. Analysis of samples are done within weeks of collection and no later than dec. 2015. Possible changes in the patient's hemostatic and inflammatory profile by evaluation of the potential effect of tranexamic acid on fibrin structure, the binding of plasminogen to fibrin. The clinical degree of postoperative facial swelling will be measured by structured light scanning (the David SLS-2) and the data evaluated by the software "LANDMARKER".;Timepoint(s) of evaluation of this end point: 1st scanning is performed 48 hours postoperatively along with the 3rd blood sample. 2nd scanning is performed 4 months postoperatively along with the 4th blood sample. Analysis of 3D data are performed within weeks of recording and no later than dec. 2015. | — |
Countries
Denmark
Contacts
Public ContactKæbekirurgisk afd.
Hospital of South West Jutland
Outcome results
None listed