NCT02702128

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

April 22, 2026

Status Verified

March 1, 2020

Enrollment Period

2.5 years

First QC Date

March 2, 2016

Last Update Submit

April 17, 2026

Conditions

Peri-operative Hemorrhage or HematomaSurgeryRetrognathism

Keywords

Bleeding perioperativeEXACYLOorthognathism surgeryHematoma

Outcome Measures

Primary Outcomes (1)

  • bleeding perioperative

    bleeding during surgery and bleeding after surgery until hospitalization discharge

    discharge from the hospital between 2 and 5 days

Secondary Outcomes (10)

  • bleeding during surgery

    end of the surgery

  • EVA comfort surgery

    end of the surgery

  • operative time

    end of the surgery

  • Delta hemoglobin

    Day 1 after surgery

  • EVA comfort patient

    day 1 after surgery

  • +5 more secondary outcomes

Study Arms (2)

Tranexamic acid

ACTIVE COMPARATOR

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

Drug: Tranexamic Acid

saline solution

PLACEBO COMPARATOR

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

Drug: saline solution

Interventions

Tranexamic AcidDRUG

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

Tranexamic acid
saline solutionDRUG

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

saline solution

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Location

Related Publications (1)

  • Jozefowicz E, Sabourdin N, Lambelin V, Lejeune V, Delassus R, Tavernier B. The effect of tranexamic acid on blood loss in orthognathic surgery: a randomized, placebo-controlled, equivalence study. Int J Oral Maxillofac Surg. 2022 May;51(5):637-642. doi: 10.1016/j.ijom.2021.08.018. Epub 2021 Aug 28.

    PMID: 34465477RESULT

MeSH Terms

Conditions

HematomaRetrognathia

Interventions

Tranexamic AcidSaline Solution

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsJaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMandibular DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Elsa Jozefowicz, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 8, 2016

Study Start

January 3, 2016

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

April 22, 2026

Record last verified: 2020-03

Locations

FR(1)