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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002175-24 | EudraCT Number |
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Prospective, randomized, double-blind, placebo-controlled, mono center, Phase III trial to compare EXACYL in preventive with placebo on perioperatory bleeding in orthognathism surgery.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Active Comparator | 1g of Tranexamic acid on 1hour and 1g of tranexamic acid on 8 hours |
|
| saline solution | Placebo Comparator | 30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 1g of tranexamic acid on 1 hour and 1g of tranexamic acid on 8 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| bleeding perioperative | bleeding during surgery and bleeding after surgery until hospitalization discharge | discharge from the hospital between 2 and 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | end of the surgery |
| EVA comfort surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elsa Jozefowicz, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Roger Salengro, CHRU de Lille | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34465477 | Result | 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. |
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| ID | Term |
|---|---|
| D006406 | Hematoma |
| D063173 | Retrognathia |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007569 | Jaw Abnormalities |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| saline solution | Drug | 30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours |
|
Visual Analogue Scale for evaluation of surgical comfort |
| end of the surgery |
| operative time | duration in minute of the surgery | 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) | Day 1 after surgery |
| EVA comfort patient | Visual Analogue Scale for assessment of patient comfort in day 1 | day 1 after surgery |
| Number of red blood cell transfused | Number of red blood cell transfused | 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 | discharge from the hospital between 2 and 5 days |
| Hospitalisation stay | Hospitalization stay on day | 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 | discharge from the hospital between 2 and 5 days |
| Thrombotic complications | Number of thrombotic complications or cardiac complications during the hospitalization | discharge from the hospital between 2 and 5 days |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D008336 | Mandibular Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |