E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Surgical bleeding during bi-maxillary orthognathic surgery
|
Intraoperativ blødningstendens ifm. bimaksillær ortognatkirurgi |
|
E.1.1.1 | Medical condition in easily understood language |
Bleeding during corrective surgery of both jaws |
Blødning under korrektiv kæbekirurgi af begge kæber |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051536 |
E.1.2 | Term | Intraoperative bleeding |
E.1.2 | System Organ Class | 100000004863 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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). |
|
E.5 End points |
E.5.1 | 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. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The blood loss is measured immediately (within minutes) after ended surgery. |
|
E.5.2 | 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". |
|
E.5.2.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS is set to ultimo novemeber 2015 |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |