Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

University Hospital, Lille157 enrolled

Overview

Prospective, randomized, double-blind, placebo-controlled, mono center, Phase III trial to compare EXACYL in preventive with placebo on perioperatory bleeding in orthognathism surgery.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

157

Conditions

Peri-operative Hemorrhage or Hematoma Surgery Retrognathism

Interventions

Tranexamic AcidDRUG

1g of tranexamic acid on 1 hour and 1g of tranexamic acid on 8 hours

saline solutionDRUG

30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Outcomes

Primary Outcomes

bleeding perioperative

bleeding during surgery and bleeding after surgery until hospitalization discharge

Time frame: discharge from the hospital between 2 and 5 days

Secondary Outcomes

bleeding during surgery

Amount of blood during surgery including : blood in the surgical aspiration, in compresses ( assessed by weighing compresses ) in the anesthetic aspiration (when extubation ) and the nasogastric tube at the end of surgery

Time frame: end of the surgery

EVA comfort surgery

Visual Analogue Scale for evaluation of surgical comfort

Time frame: end of the surgery

operative time

duration in minute of the surgery

Time frame: end of the surgery

Delta hemoglobin

Difference between preoperative hemoglobin and postoperative ( Measured on the first preoperative and the second on the assessment conducted on Day 1)

Time frame: Day 1 after surgery

EVA comfort patient

Visual Analogue Scale for assessment of patient comfort in day 1

Time frame: day 1 after surgery

Number of red blood cell transfused

Time frame: discharge from the hospital between 2 and 5 days

EVA fatigue patient

visual analogue scale for assessment of the fatigue of the patient to the hospital discharge

Data from ClinicalTrials.gov

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