Peri-operative Hemorrhage or HematomaPhase 3LEFORTEXACYLNCT02702128
Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery
A Phase 3 study testing Tranexamic Acid and saline solution in people with Peri-operative Hemorrhage or Hematoma and Surgery, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Peri-operative Hemorrhage or Hematoma, Surgery, Retrognathism
- What is being tested?
- Tranexamic Acid and saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2016to 30 Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Prospective, randomized, double-blind, placebo-controlled, mono center, Phase III trial to compare EXACYL in preventive with placebo on perioperatory bleeding in orthognathism surgery.
Read the 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.
- Being tested
- Tranexamic Acid, saline solution
- Keywords
- Bleeding perioperative, EXACYL, Oorthognathism surgery, Hematoma
- Medical subject headings
- Hematoma, Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
1g of tranexamic acid on 1 hour and 1g of tranexamic acid on 8 hours
saline solutionDrug
30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Active comparator | 1g of Tranexamic acid on 1hour and 1g of tranexamic acid on 8 hours Receives: Drug: Tranexamic Acid |
| saline solution | Placebo comparator | 30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours Receives: Drug: saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding perioperative
bleeding during surgery and bleeding after surgery until hospitalization discharge
Measured: discharge from the hospital between 2 and 5 days
Secondary outcomes (10)
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
Measured: end of the surgery
EVA comfort surgery
Visual Analogue Scale for evaluation of surgical comfort
Measured: end of the surgery
operative time
duration in minute of the surgery
Measured: end of the surgery
Delta hemoglobin
Difference between preoperative hemoglobin and postoperative ( Measured on the first preoperative and the second on the assessment conducted on Day 1)
Measured: Day 1 after surgery
EVA comfort patient
Visual Analogue Scale for assessment of patient comfort in day 1
Measured: day 1 after surgery
Number of red blood cell transfused
Number of red blood cell transfused
Measured: discharge from the hospital between 2 and 5 days
EVA fatigue patient
visual analogue scale for assessment of the fatigue of the patient to the hospital discharge
Measured: discharge from the hospital between 2 and 5 days
Hospitalisation stay
Hospitalization stay on day
Measured: discharge from the hospital between 2 and 5 days
Incidence of nausea and vomiting
Incidence of nausea and vomiting calculated by the anti emetic dose received by the patient during hospitalisation
Measured: discharge from the hospital between 2 and 5 days
Thrombotic complications
Number of thrombotic complications or cardiac complications during the hospitalization
Measured: discharge from the hospital between 2 and 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start3 Jan 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri-operative Hemorrhage or HematomaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elsa Jozefowicz, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702128
- Sponsor's protocol ID
- 2014_68
- Other IDs
- 2015-002175-24, 2015
- Acronym
- LEFORTEXACYL
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2016
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34465477
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery
- ClinicalTrials.gov ID
- NCT02702128
- Acronym / sponsor ID
- LEFORTEXACYL / 2014_68
- Keywords
- Bleeding perioperative, EXACYL, Oorthognathism surgery, Hematoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 3 Jan 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Active comparator | Drug: Tranexamic Acid1g of Tranexamic acid on 1hour and 1g of tranexamic acid on 8 hours |
| saline solution | Placebo comparator | Drug: saline solution30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid1g of tranexamic acid on 1 hour and 1g of tranexamic acid on 8 hours | Drug | Tranexamic acid |
| saline solution30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours | Drug | saline solution |
Primary outcome
bleeding perioperative
Time frame: discharge from the hospital between 2 and 5 days
bleeding during surgery and bleeding after surgery until hospitalization discharge
10 secondary outcomes
bleeding during surgery
Time frame: end of the surgery
EVA comfort surgery
Time frame: end of the surgery
operative time
Time frame: end of the surgery
Delta hemoglobin
Time frame: Day 1 after surgery
EVA comfort patient
Time frame: day 1 after surgery
Number of red blood cell transfused
Time frame: discharge from the hospital between 2 and 5 days
EVA fatigue patient
Time frame: discharge from the hospital between 2 and 5 days
Hospitalisation stay
Time frame: discharge from the hospital between 2 and 5 days
Incidence of nausea and vomiting
Time frame: discharge from the hospital between 2 and 5 days
Thrombotic complications
Time frame: discharge from the hospital between 2 and 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 34465477Jozefowicz 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elsa Jozefowicz, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid and saline solution in people with Peri-operative Hemorrhage or Hematoma and Surgery, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding perioperative (time frame: discharge from the hospital between 2 and 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02702128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.