Can a simple drug cut bleeding in jaw surgery?
NCT ID NCT02702128
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether giving EXACYL before surgery can reduce bleeding during and after jaw realignment surgery. 157 adults took part in a double-blind, placebo-controlled Phase 3 trial. The goal was to see if the drug makes surgery safer and more comfortable.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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157 people
The number who actually took part.
- Started
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Jan 2016
- Finished
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Jun 2018
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hôpital Roger Salengro, CHRU de Lille
Lille, France
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