NCT00618293撤回2 期
Phase 2 Study in Evaluation of the Efficacy and Safety of Haemate HS in This Clinical Setting (Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis)
Heinrich-Heine University, Duesseldorf1 个研究点 分布在 1 个国家开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- intra- and postoperative transfusion requirements of packed red cells, platelet concentrates and fresh frozen plasma according to defined transfusion thresholds
研究概览
简要总结
Evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of Von Willebrand factor concentrate F VIII (Haemate).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with isolated valvular aortic stenosis or combined aortic-valve defect with prevailing stenosis with severe bleeding during aortic-valve replacement
- •Caucasian
- •written informed consent (Classification of bleeding as "normal", "moderate" or "excessive" by the surgeon.Classification as excessive leads to recruitment)
排除标准
- •active endocarditis
- •history suggestive for inherited oe acquired bleeding disorder
- •concomitant coronary heart disease
- •agents impairing platelet function up to 14 days before surgery
- •Pregnancy
- •inherited platelet function
- •known intolerance against HAEMATE HS
- •previous thromboembolic complications
- •Hepatitis B, C or HIV infection
- •previous chemotherapy
- •emergency surgery within the last 7 days
- •weight < 50 kg and > 100 kg
研究组 & 干预措施
1
Active Comparator
intravenous infusion of Haemate (dosage dependent on body weight)
干预措施: Haemate HS (Drug)
2
Placebo Comparator
intravenous infusion of 0.9% NaCl solution
干预措施: NaCl-solution (Other)
结局指标
主要结局
intra- and postoperative transfusion requirements of packed red cells, platelet concentrates and fresh frozen plasma according to defined transfusion thresholds
时间窗: begin of surgery and 48h after administration of medication
次要结局
- Assessment of adverse events and viral safety(1.perioperative 2. during hospital admission 3. within 90 days after surgery)
研究者
研究点 (1)
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