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

University Hospital, Lille

Status and phase: Completed; Phase 3

Conditions: Peri-operative Hemorrhage or Hematoma; Surgery; Retrognathism

Treatments: Drug: saline solution; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02702128

2015-002175-24 (EudraCT Number)

2014_68

Details and patient eligibility

About

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

Full 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.

Enrollment: 157 patients

Sex: All

Ages: 12+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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157 participants in 2 patient groups, including a placebo group

Tranexamic acid

Active Comparator group

Description:

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

Treatment:

Drug: Tranexamic Acid

saline solution

Placebo Comparator group

Description:

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

Treatment:

Drug: saline solution