Peri-operative Hemorrhage or Hematoma, Retrognathism, Surgery
Conditions
Keywords
Bleeding perioperative, EXACYL, Oorthognathism surgery, Hematoma
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.
Interventions
DRUGTranexamic Acid
1g of tranexamic acid on 1 hour and 1g of tranexamic acid on 8 hours
DRUGsaline solution
30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bleeding perioperative | discharge from the hospital between 2 and 5 days | bleeding during surgery and bleeding after surgery until hospitalization discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| operative time | end of the surgery | duration in minute of the surgery |
| 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 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 |
| 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 |
| Hospitalisation stay | discharge from the hospital between 2 and 5 days | Hospitalization stay on day |
| 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 |
| Thrombotic complications | discharge from the hospital between 2 and 5 days | Number of thrombotic complications or cardiac complications during the hospitalization |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORElsa Jozefowicz, MD
University Hospital, Lille
Outcome results
None listed