Clinical trial NCT02702128: Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery
Official title: Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peri-operative Hemorrhage or Hematoma
Surgery
Retrognathism
Keywords: Bleeding perioperative
EXACYL
Oorthognathism surgery
Hematoma
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 157
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: bleeding perioperative
timeFrame: discharge from the hospital between 2 and 5 days
Secondary outcomes:
measure: bleeding during surgery
timeFrame: end of the surgery
measure: EVA comfort surgery
timeFrame: end of the surgery
measure: operative time
timeFrame: end of the surgery
measure: Delta hemoglobin
timeFrame: Day 1 after surgery
measure: EVA comfort patient
timeFrame: day 1 after surgery
measure: Number of red blood cell transfused
timeFrame: discharge from the hospital between 2 and 5 days
measure: EVA fatigue patient
timeFrame: discharge from the hospital between 2 and 5 days
measure: Hospitalisation stay
timeFrame: discharge from the hospital between 2 and 5 days
measure: Incidence of nausea and vomiting
timeFrame: discharge from the hospital between 2 and 5 days
measure: Thrombotic complications
timeFrame: discharge from the hospital between 2 and 5 days
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Elsa Jozefowicz, MD
role: PRINCIPAL_INVESTIGATOR
References: