Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

Study Overview
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Brief Summary
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Prospective, randomized, double-blind, placebo-controlled, mono center, Phase III trial to compare EXACYL in preventive with placebo on perioperatory bleeding in orthognathism surgery.

Detailed Description
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The aim of our study was to evaluate the clinical value of preventive treatment EXACYL® on bleeding during surgery to orthognathism. Our hypothesis is that this preventive treatment is not enough reduces bleeding to cause a change in patient management (count additional blood count, extra padding, transfusion). Prospective equivalence trial type controlled by two parallel group, randomized, triple-blind (patient, surgical team, anesthesia team). EXACYL® Group: 1 syringe 1g EXACYL® on one hour + 1 syringe 1g EXACYL® on 8 hours Control group: 1 syringe 30 mL of saline on one hour + 1 syringe 30 mL saline on 8 hours Main criteria is amount of blood during the entire hospitalization: bleeding during surgery completed in the amount of blood present in the suction drains and nasogastric tube until ablation thereof.

Official Title
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Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

Conditions
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Peri-operative Hemorrhage or Hematoma, Surgery, Retrognathism

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients to be operated on an osteotomy of the maxilla through a orthognathism surgery in the department of surgical specialties Salengro hospital Senior surgeon Hb ≥ 12 g / dL in the preoperative Patient ASA 1 or 2 Exclusion Criteria: Patient with coagulation disorders Patients treated with anticoagulant or antiplatelet Patients who require anticoagulation postoperatively Patient with against-indication to EXACYL® ( severe renal failure , convulsions history, history of thromboembolism venous or arterial ) Surgery recognized preoperatively as particularly complicated by surgeons

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic acid<br>1g of Tranexamic acid on 1hour and 1g of tranexamic acid on 8 hours | Drug: Tranexamic Acid<br>* 1g of tranexamic acid on 1 hour and 1g of tranexamic acid on 8 hours<br>|
| Placebo Comparator: saline solution<br>30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours | Drug: saline solution<br>* 30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding perioperative | bleeding during surgery and bleeding after surgery until hospitalization discharge | discharge from the hospital between 2 and 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding during surgery | Amount of blood during surgery including : blood in the surgical aspiration, in compresses ( assessed by weighing compresses ) in the anesthetic aspiration (when extubation ) and the nasogastric tube at the end of surgery | end of the surgery | 
| EVA comfort surgery | Visual Analogue Scale for evaluation of surgical comfort | end of the surgery | 
| operative time | duration in minute of the surgery | end of the surgery | 
| Delta hemoglobin | Difference between preoperative hemoglobin and postoperative ( Measured on the first preoperative and the second on the assessment conducted on Day 1) | Day 1 after surgery | 
| EVA comfort patient | Visual Analogue Scale for assessment of patient comfort in day 1 | day 1 after surgery | 
| Number of red blood cell transfused | Number of red blood cell transfused | discharge from the hospital between 2 and 5 days | 
| EVA fatigue patient | visual analogue scale for assessment of the fatigue of the patient to the hospital discharge | discharge from the hospital between 2 and 5 days | 
| Hospitalisation stay | Hospitalization stay on day | discharge from the hospital between 2 and 5 days | 
| Incidence of nausea and vomiting | Incidence of nausea and vomiting calculated by the anti emetic dose received by the patient during hospitalisation | discharge from the hospital between 2 and 5 days | 
| Thrombotic complications | Number of thrombotic complications or cardiac complications during the hospitalization | discharge from the hospital between 2 and 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bleeding perioperative, EXACYL, Oorthognathism surgery, Hematoma