Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery (LEFORTEXACYL)

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

Study Overview

• Status: Completed
• Conditions: Surgery; Retrognathism; Peri-operative Hemorrhage or Hematoma
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: saline solution

Detailed Description

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
• Enrollment (Actual): 157
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Roger Salengro, CHRU de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tranexamic acid; 1g of Tranexamic acid on 1hour and 1g of tranexamic acid on 8 hours	Drug: Tranexamic Acid; 1g of tranexamic acid on 1 hour and 1g of tranexamic acid on 8 hours
Placebo Comparator: saline solution; 30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours	Drug: saline solution; 30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bleeding perioperative	bleeding during surgery and bleeding after surgery until hospitalization discharge	discharge from the hospital between 2 and 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	end of the surgery
EVA comfort surgery	Visual Analogue Scale for evaluation of surgical comfort	end of the surgery
operative time	duration in minute of the surgery	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)	Day 1 after surgery
EVA comfort patient	Visual Analogue Scale for assessment of patient comfort in day 1	day 1 after surgery
Number of red blood cell transfused	Number of red blood cell transfused	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	discharge from the hospital between 2 and 5 days
Hospitalisation stay	Hospitalization stay on day	discharge from the hospital between 2 and 5 days
Incidence of nausea and vomiting	Incidence of nausea and vomiting calculated by the anti emetic dose received by the patient during hospitalisation	discharge from the hospital between 2 and 5 days
Thrombotic complications	Number of thrombotic complications or cardiac complications during the hospitalization	discharge from the hospital between 2 and 5 days

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2016
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 2, 2016
• First Posted (Estimate): March 8, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Hematoma; Bleeding perioperative; EXACYL; Oorthognathism surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Hematoma; Retrognathia; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2014_68; 2015-002175-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No