CompletedPhase 3

Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

France157 participantsStarted 2016-01-03

Plain-language 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.

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

bleeding perioperative

Timeframe: discharge from the hospital between 2 and 5 days

Trial details

NCT IDNCT02702128

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-30

View on ClinicalTrials.gov More Peri-operative Hemorrhage or Hematoma trials