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

Primary Purpose

Peri-operative Hemorrhage or Hematoma, Surgery, Retrognathism

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Tranexamic Acid
saline solution
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peri-operative Hemorrhage or Hematoma focused on measuring Bleeding perioperative, EXACYL, Oorthognathism surgery, Hematoma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Roger Salengro, CHRU de Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic acid

saline solution

Arm Description

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

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

Outcomes

Primary Outcome Measures

bleeding perioperative
bleeding during surgery and bleeding after surgery until hospitalization discharge

Secondary Outcome Measures

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
EVA comfort surgery
Visual Analogue Scale for evaluation of surgical comfort
operative time
duration in minute 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)
EVA comfort patient
Visual Analogue Scale for assessment of patient comfort in day 1
Number of red blood cell transfused
Number of red blood cell transfused
EVA fatigue patient
visual analogue scale for assessment of the fatigue of the patient to the hospital discharge
Hospitalisation stay
Hospitalization stay on day
Incidence of nausea and vomiting
Incidence of nausea and vomiting calculated by the anti emetic dose received by the patient during hospitalisation
Thrombotic complications
Number of thrombotic complications or cardiac complications during the hospitalization

Full Information

First Posted
March 2, 2016
Last Updated
October 15, 2020
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT02702128
Brief Title
Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery
Acronym
LEFORTEXACYL
Official Title
Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 3, 2016 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-operative Hemorrhage or Hematoma, Surgery, Retrognathism
Keywords
Bleeding perioperative, EXACYL, Oorthognathism surgery, Hematoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Active Comparator
Arm Description
1g of Tranexamic acid on 1hour and 1g of tranexamic acid on 8 hours
Arm Title
saline solution
Arm Type
Placebo Comparator
Arm Description
30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
1g of tranexamic acid on 1 hour and 1g of tranexamic acid on 8 hours
Intervention Type
Drug
Intervention Name(s)
saline solution
Intervention Description
30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours
Primary Outcome Measure Information:
Title
bleeding perioperative
Description
bleeding during surgery and bleeding after surgery until hospitalization discharge
Time Frame
discharge from the hospital between 2 and 5 days
Secondary Outcome Measure Information:
Title
bleeding during surgery
Description
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
Title
EVA comfort surgery
Description
Visual Analogue Scale for evaluation of surgical comfort
Time Frame
end of the surgery
Title
operative time
Description
duration in minute of the surgery
Time Frame
end of the surgery
Title
Delta hemoglobin
Description
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
Title
EVA comfort patient
Description
Visual Analogue Scale for assessment of patient comfort in day 1
Time Frame
day 1 after surgery
Title
Number of red blood cell transfused
Description
Number of red blood cell transfused
Time Frame
discharge from the hospital between 2 and 5 days
Title
EVA fatigue patient
Description
visual analogue scale for assessment of the fatigue of the patient to the hospital discharge
Time Frame
discharge from the hospital between 2 and 5 days
Title
Hospitalisation stay
Description
Hospitalization stay on day
Time Frame
discharge from the hospital between 2 and 5 days
Title
Incidence of nausea and vomiting
Description
Incidence of nausea and vomiting calculated by the anti emetic dose received by the patient during hospitalisation
Time Frame
discharge from the hospital between 2 and 5 days
Title
Thrombotic complications
Description
Number of thrombotic complications or cardiac complications during the hospitalization
Time Frame
discharge from the hospital between 2 and 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elsa Jozefowicz, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Roger Salengro, CHRU de Lille
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

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