Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- bleeding perioperative
研究概览
简要总结
Prospective, randomized, double-blind, placebo-controlled, mono center, Phase III trial to compare EXACYL in preventive with placebo on perioperatory bleeding in orthognathism surgery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tranexamic acid
1g of Tranexamic acid on 1hour and 1g of tranexamic acid on 8 hours
干预措施: Tranexamic Acid (Drug)
saline solution
30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours
干预措施: saline solution (Drug)
结局指标
主要结局
bleeding perioperative
时间窗: discharge from the hospital between 2 and 5 days
bleeding during surgery and bleeding after surgery until hospitalization discharge
次要结局
- bleeding during surgery(end of the surgery)
- EVA comfort surgery(end of the surgery)
- Hospitalisation stay(discharge from the hospital between 2 and 5 days)
- operative time(end of the surgery)
- EVA comfort patient(day 1 after surgery)
- Number of red blood cell transfused(discharge from the hospital between 2 and 5 days)
- Delta hemoglobin(Day 1 after surgery)
- EVA fatigue patient(discharge from the hospital between 2 and 5 days)
- Thrombotic complications(discharge from the hospital between 2 and 5 days)
- Incidence of nausea and vomiting(discharge from the hospital between 2 and 5 days)