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NCT Number: NCT02702128

Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

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

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Key information

Conditions

Peri-operative Hemorrhage or Hematoma Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Hematoma Hemorrhage Jaw Abnormalities Jaw Diseases Mandibular Diseases Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Retrognathia Retrognathism Stomatognathic Diseases Stomatognathic System Abnormalities Surgery

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Roger Salengro, CHRU de Lille

Lille, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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

Saline Solution

Drug

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

Primary outcomes

  1. bleeding perioperative

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

    bleeding during surgery and bleeding after surgery until hospitalization discharge

Secondary outcomes

  1. bleeding during surgery

    Time frame: end of the 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

  2. EVA comfort surgery

    Time frame: end of the surgery

    Visual Analogue Scale for evaluation of surgical comfort

  3. operative time

    Time frame: end of the surgery

    duration in minute of the surgery

  4. Delta hemoglobin

    Time frame: Day 1 after surgery

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

  5. EVA comfort patient

    Time frame: day 1 after surgery

    Visual Analogue Scale for assessment of patient comfort in day 1

  6. Number of red blood cell transfused

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

    Number of red blood cell transfused

  7. EVA fatigue patient

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

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

  8. Hospitalisation stay

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

    Hospitalization stay on day

  9. Incidence of nausea and vomiting

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

    Incidence of nausea and vomiting calculated by the anti emetic dose received by the patient during hospitalisation

  10. Thrombotic complications

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

    Number of thrombotic complications or cardiac complications during the hospitalization

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: LEFORTEXACYL

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2016
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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