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