Multi-Center Trial of Desirudin for the Prophylaxis of Thrombosis: an Alternative to Heparin-Based Anticoagulation (DESIR-ABLE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 516
- 试验地点
- 15
- 主要终点
- Major Bleeding
研究概览
简要总结
The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.
详细描述
Hospitalized patients who require DVT prophylaxis and who are not good candidates for heparin-based anti-coagulation were eligible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Provide written informed consent before initiation of any study related procedures.
- •Be at least 18 years of age.
- •Patients requiring anticoagulation for the prophylaxis of thrombosis.
- •In the opinion of the Investigator, an alternative to heparin-based anticoagulant therapies is desirable.
排除标准
- •Confirmed pregnancy (if woman of child-bearing potential) (urine or serum pregnancy test).
- •Intracranial neoplasm, arteriovenous malformation or aneurysm.
- •Severe renal insufficiency (chronic or acute) with a GFR of < or equal to 30 mL/min as determined by measured or estimated creatinine clearance using Cockroft-Gault method or by estimated GFR using the MDRD formula.
- •Known allergy to desirudin or hirudin-derived drugs, or known sensitivity to any component of the product
- •Participation in other clinical research studies involving the evaluation of other investigational or FDA-approved drugs or devices within 30 days of enrollment (participation in observational studies of FDA-approved products is acceptable).
- •Refusal to undergo blood transfusion should it become necessary
- •Active bleeding or irreversible coagulation abnormality.
- •Uncontrolled hypertension defined as a blood pressure > or equal to 180/110 mmHg.
- •Patients requiring anticoagulation for left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration or ECMO.
- •Any other disease or condition which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.
研究组 & 干预措施
Desirudin
desirudin 15 mg twice daily for a minimum of 5 days
干预措施: Desirudin (Drug)
结局指标
主要结局
Major Bleeding
时间窗: 24 hours after last dose of study drug
Major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the peri-operative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint.
次要结局
- Thrombosis(Up until 24 hours after last dose of study drug)