Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-03

Study Completion Date

2018-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Peri-operative Hemorrhage or Hematoma Surgery Retrognathism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tranexamic acid

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

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

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

saline solution

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

Group Type PLACEBO_COMPARATOR

saline solution

Intervention Type DRUG

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

Interventions

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Tranexamic Acid

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

Intervention Type DRUG

saline solution

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No