NCT02702128

Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peri-operative Hemorrhage or Hematoma
• Surgery
• Retrognathism

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	1g of tranexamic acid on 1 hour and 1g of tranexamic acid on 8 hours
DRUG	saline solution	30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours

Timeline

• Start date: 2016-01-03
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2016-03-08
• Last updated: 2020-10-19

Locations

1 site across 1 country: France