Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- blood loss
研究概览
简要总结
Acquired Von Willebrand disease (type 2A) has been described in patients with severe aortic stenosis, the association of aortic stenosis and Digestive bleeding due to this phenomena has received the name of Heye´s syndrome.
We propose that administering Desmopressin (DDAVP) in patients scheduled to aortic valve replacement surgery will reduce blood loss and transfusion rate.
this was a pilot study
详细描述
Randomized Controlled trial compared with placebo in a double blind fashion. Subjects with severe aortic stenosis (transvalvular gradient >50 mmHg or valvular area of lass than 1 cm2) scheduled for aortic valve replacement were enrolled.
the day of surgery blood samples were taken in order to confirm diagnosis (factor VIII activity and Protein electrophoresis for Von Willebrand´s multimers) and then 0,3 mcg/k of DDAVP or saline equally labeled as "study drug" were administered en 30 minutes a half hour before incision.
Blood loss, postoperative hematocrit and transfusion requirement were measured, plasma sodium was measured as a safety issue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe aortic stenosis defined as mean transvalvular gradient greater or equal to 40 mmHg ot transvalvular area less than 1 cm2
- •scheduled for aortic valve replacement surgery
排除标准
- •combined surgery (plus coronary artery bypass graft or other valve replacement/plasty)
- •Infective Endocarditis
- •previously known haemostatic disorder
- •previous treatment with oral anticoagulants or IIb-IIIa inhibitors (we did not exclude those on acetyl-salicylic acid)
研究组 & 干预措施
Desmopressin
0,3 mcg per kilogram of desmopressin in 100 ml of saline, labeled as "study drug" and administered in 30 minutes a half hour before surgical incision
干预措施: desmopressin (Drug)
placebo
100 of saline labeled as "study drug" administered in 30 minutes a half hour before surgical incision
干预措施: desmopressin (Drug)
结局指标
主要结局
blood loss
时间窗: once patient arrives to post anesthesia care unit (approximately 6 hours after drug administration
Blood loss obtained from fluid balance of surgery plus drain output
次要结局
- need of transfusion(48 hours post administration)
- postoperative hematocrit(the morning after surgery (18-24 hours after drug administration))
研究者
MPoblete
Anesthesiologist
Pontificia Universidad Catolica de Chile