Placebo-Controlled, Randomized, Double-Blind Trial of Prophylactic Desmopressin in Heart Valve Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in coagulation parameters
研究概览
简要总结
The purpose of this study is evaluate the effect of prophylactic desmopressin on blood coagulation parameters and postoperative bleeding in patients undergoing valve cardiac surgery with cardiopulmonary bypass.
详细描述
Patients with important valve disorders may evaluate with coagulopathy induced by mechanical effects (valvular stenosis or valvular insufficiency). Furthermore, frequently is required prophylactic use of antiplatelet drugs due to myocardial remodeling and antiarrhythmic conditions that may be associated. Patients with severe aortic stenosis may also acquired von Willebrand disease type 2A due to proteolysis of vonWillebrand factor. Despite of this, the treatment of valve disorders often requires cardiac surgery with cardiopulmonary bypass. On average 50 to 60% of patients undergoing cardiac surgery receive blood tranfusions. Blood cell transfusion is an independent risk factor for increased morbidity and mortality in critically ill patients. The use of desmopressin seems beneficial only in patients with congenital or acquired platelet dysfunction. In general population, such use is not validated due to inconclusive results of researches.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Valve cardiac surgery with cardiopulmonary bypass.
- •Written informed consent
排除标准
- •Reoperative valve surgery
- •Hematocrit < 35%
- •Ventricular dysfunction (EF < 40%)
- •Infection
- •Body mass index > 35
- •Renal impairment (Creatinin > 2mg/dL)
- •Antiplatelet administration within 10 days preceding study surgery
- •Participation in another interventional clinical study within 30 days
- •Known or suspected hypersensitivity to the desmopressin
- •Coagulopathy (INR > 1.5)
研究组 & 干预措施
desmopressin
Patients randomized to this group receive desmopressin 0,3 microgram.kg-1 as an intravenous infusion given during 20 min.
干预措施: Desmopressin (Drug)
Placebo
Patients randomized to the control group will receive the infusion of 100 mL 0.9% saline (SF0,9%).
干预措施: Placebo (Drug)
结局指标
主要结局
Change in coagulation parameters
时间窗: Coagulation parameters will be performed: T0: preoperative period; T1 - 2 hours after desmopressin or placebo administration; T2 - 24 hours after desmopressin or placebo administration
Laboratory variables: Activated partial thromboplastin time \[(aPTT) seconds\], prothrombin time \[(PT) seconds\], haematocrit (%), haemoglobin(g/dl), fibrinogen(mg/dL), D dimer (ng/L), factor VIII(%), Von Willebrand factor(%), ROTEM \[(INTEM, EXTEM, FIBTEM) Clotting Time (CT) and Clot Formation Time (CFT) seconds, alpha angle (α º), Maximum Clot Firmness (MCF) mm \] and platelets aggregation (%)
Postoperative blood loss
时间窗: 48 hours
Total chest tube drainage (mL) starting immediately after closure of the chest in the operating theater until 48 hours
次要结局
- Length of ICU stay(30 days)
- Clinical complications - renal failure, infection, myocardial ischemia, stroke(30 days)
- Length of hospital stay(30 days)
- Mortality(30 days)
- Duration of Mechanical ventilation(30 days)
- Blood transfusion(30 days)
- Reoperation for bleeding(30 days)
- Length of vasoactive drugs(30 days)
研究者
Filomena R B G Galas
Associate Professor
Instituto do Coracao