Overview

Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

Status:
Completed
Trial end date:
2018-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Lille
Treatments:
Pharmaceutical Solutions
Tranexamic Acid
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