Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

Surgery Clinical Trial

— LEFORTEXACYL  

Official title:

Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702128
• Other study ID #: 2014_68
• Secondary ID: 2015-002175-24
• Status: Completed
• Phase: Phase 3
• Start date: January 3, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: March 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hematoma
• Hemorrhage
• Peri-operative Hemorrhage or Hematoma
• Retrognathia
• Retrognathism
• Surgery

Intervention

Drug:
• Tranexamic Acid
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

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHRU de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bleeding perioperative	bleeding during surgery and bleeding after surgery until hospitalization discharge	discharge from the hospital between 2 and 5 days
Secondary	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	end of the surgery
Secondary	EVA comfort surgery	Visual Analogue Scale for evaluation of surgical comfort	end of the surgery
Secondary	operative time	duration in minute of the surgery	end of the surgery
Secondary	Delta hemoglobin	Difference between preoperative hemoglobin and postoperative ( Measured on the first preoperative and the second on the assessment conducted on Day 1)	Day 1 after surgery
Secondary	EVA comfort patient	Visual Analogue Scale for assessment of patient comfort in day 1	day 1 after surgery
Secondary	Number of red blood cell transfused	Number of red blood cell transfused	discharge from the hospital between 2 and 5 days
Secondary	EVA fatigue patient	visual analogue scale for assessment of the fatigue of the patient to the hospital discharge	discharge from the hospital between 2 and 5 days
Secondary	Hospitalisation stay	Hospitalization stay on day	discharge from the hospital between 2 and 5 days
Secondary	Incidence of nausea and vomiting	Incidence of nausea and vomiting calculated by the anti emetic dose received by the patient during hospitalisation	discharge from the hospital between 2 and 5 days
Secondary	Thrombotic complications	Number of thrombotic complications or cardiac complications during the hospitalization	discharge from the hospital between 2 and 5 days