Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

Last updated: October 15, 2020
Sponsor: University Hospital, Lille
Overall Status: Completed

Phase

3

Condition

Surgery

Hemorrhage

Treatment

N/A

Clinical Study ID

NCT02702128
2014_68
2015-002175-24
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients to be operated on an osteotomy of the maxilla through a orthognathism surgeryin the department of surgical specialties Salengro hospital

  • Senior surgeon

  • Hb ≥ 12 g / dL in the preoperative

  • Patient ASA 1 or 2

Exclusion

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 , convulsionshistory, history of thromboembolism venous or arterial )

  • Surgery recognized preoperatively as particularly complicated by surgeons

Study Design

Total Participants: 157
Study Start date:
January 03, 2016
Estimated Completion Date:
June 30, 2018

Study 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.

Connect with a study center

  • Hôpital Roger Salengro, CHRU de Lille

    Lille,
    France

    Site Not Available

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