Bleeding during surgery of orthognatism of the upper maxillary
Conditions
Interventions
Trade Name: EXACYL 0,5 g/5 mL I.V., solution injectable
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous us
Sponsors
Centre Hospitalier Régional et Universitaire de Lille
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Underage from = 12 to 17 years old or an Adult from = 18 years old - Patient that must be operated for an osteotomy of the upper maxillary isolated or associated with an osteotomy of the lower maxillary and / or with a génioplastie within the framework of a surgery of orthognatism - Hb = 12g / dL on the preoperative screening - Patient ASA (American Society of Anesthesiologists) 1 or 2 - Patient non pregnant - Be a person covered by Social Security - Signed Consent Are the trial subjects under 18? yes Number of subjects for this age range: 189 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 21 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient presenting disorders of the hemostasis Patient under anticoagulation treatment or antiagrégant Patient requiring a treatment anticoagulation in operating comment Patient presenting a contraindication to the EXACYL (renal insufficiency engraves(burns), histories of convulsions, histories of accidents thrombo-embolics venous or arterial) Surgery recognized preoperative as particularly complicated by the surgeons Pregnant Women Nursing mothers People in emergency situation Incapable people and specially protected mentioned in the article L 1121-5 to L1121-8 are not included in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Show that the EXACYL, in preventive, does not allow to modify the bleeding by comparison to the placebo during surgery of orthognatisme of the upper maxillary.;Secondary Objective: Compare according to the 2 groups: - The quantity of blood during the surgery - The surgical comfort - The operating duration - The variation of hemoglobin - The comfort of the patient - The number of transfused caps - Fatigue of the patient - The duration of hospitalization Describe the adverse effects and possible complications of the drip of EXACYL ;Primary end point(s): Show that the EXACYL does not allow to modify the bleeding by comparison to the placebo during surgery of orthognatisme of the upper maxillary.;Timepoint(s) of evaluation of this end point: Quantity of blood during the whole hospitalization: bleeding during the surgery completed by the quantity of present blood in redons and the naso-gastric probe until ablation of these. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Compare according to the 3 groups: - The quantity of blood during the surgery - The surgical comfort - The operating duration - The variation of hemoglobin - The comfort of the patient - The number of transfused caps - Fatigue of the patient - The duration of hospitalization Describe the adverse effects and the possible complications of the drip of EXACYL;Timepoint(s) of evaluation of this end point: - Quantity of blood during the including surgery: the blood in the surgical suction, in the compresses (estimate by weighing of compresses), in the anesthetic suction (during the extubation) and in the naso-gastric probe at the end of the surgery - Operating duration - Difference between the rate of preoperative hemoglobin and the operating comment - Analog visual scale for the evaluation of the comfort of the patient to D1 - Number of transfused cap - Analog visual scale for the evaluation of the fatigue of the patient at the release of hospitalization - Incidence of the nausea and the vomitings and total dose of antiemetic - Number of thrombotic complications/cardiac complications during the period of the hospitalization | — |
Countries
France
Contacts
Public ContactHanane TIJANI
Centre Hospitalier Régional et Universitaire de Lille
Outcome results
None listed