Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery
- Conditions
- Peri-operative Hemorrhage or HematomaSurgeryRetrognathism
- Interventions
- Drug: saline solution
- Registration Number
- NCT02702128
- Lead Sponsor
- University Hospital, Lille
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 157
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description saline solution saline solution 30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours Tranexamic acid Tranexamic Acid 1g of Tranexamic acid on 1hour and 1g of tranexamic acid on 8 hours
- Primary Outcome Measures
Name Time Method bleeding perioperative discharge from the hospital between 2 and 5 days bleeding during surgery and bleeding after surgery until hospitalization discharge
- Secondary Outcome Measures
Name Time Method bleeding during surgery end of the 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
EVA comfort surgery end of the surgery Visual Analogue Scale for evaluation of surgical comfort
Hospitalisation stay discharge from the hospital between 2 and 5 days Hospitalization stay on day
operative time end of the surgery duration in minute of the surgery
EVA comfort patient day 1 after surgery Visual Analogue Scale for assessment of patient comfort in day 1
Number of red blood cell transfused discharge from the hospital between 2 and 5 days Number of red blood cell transfused
Delta hemoglobin Day 1 after surgery Difference between preoperative hemoglobin and postoperative ( Measured on the first preoperative and the second on the assessment conducted on Day 1)
EVA fatigue patient discharge from the hospital between 2 and 5 days visual analogue scale for assessment of the fatigue of the patient to the hospital discharge
Thrombotic complications discharge from the hospital between 2 and 5 days Number of thrombotic complications or cardiac complications during the hospitalization
Incidence of nausea and vomiting discharge from the hospital between 2 and 5 days Incidence of nausea and vomiting calculated by the anti emetic dose received by the patient during hospitalisation
Trial Locations
- Locations (1)
Hôpital Roger Salengro, CHRU de Lille
🇫🇷Lille, France
Hôpital Roger Salengro, CHRU de Lille🇫🇷Lille, France