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Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

NCT02702128 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Peri-operative Hemorrhage or Hematoma
  • Surgery
  • Retrognathism

Interventions

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

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Elsa Jozefowicz, MD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-03
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02702128 on ClinicalTrials.gov