Safety of Heparin Anticoagulation for Prevention of Death in Patients With Septic Shock.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of major bleeding
研究概览
简要总结
Sepsis is a syndrome comprised of a systemic inflammatory response, signs of tissue hypoperfusion, and organ in the setting of presumed infection. Heparin, in addition to being an anticoagulant, is also a well-known antiinflammatory. The investigators believe that unfractionated heparin has the potential to save the lives of septic patients at a drastically reduced cost. This is a dose escalation study to determine the safety of increasing levels of heparin in this patient population; compare markers of anticoagulation and inflammation between treatment groups; and compare clinical outcomes between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90 in the medical or surgical intensive care unit
- •Within 24 hours of diagnosis with sepsis as defined by the Bone criteria (see Appendix A);
- •Acute Physiology and Chronic Health Evaluation (APACHE II) score of > 25;
- •Signed consent
排除标准
- •Currently therapeutically anticoagulated for known thrombotic diagnosis (myocardial infarction, venous thromboembolism) known molecular hypercoagulable state (Factor V Leiden, lupus anticoagulant, antiphospholipid antibody syndrome); or use of cardiopulmonary support machines (left-ventricular assist device, intra-aortic balloon pump, veno-venous ultrafiltration, or extracorporeal membrane oxygenation.
- •History of gastrointestinal or cerebral hemorrhage within past 3 months;
- •Active bleeding;
- •Known allergy or sensitivity to heparin;
- •History of heparin-induced thrombocytopenia
- •Organ transplantation recipient -
研究组 & 干预措施
intravenous heparin aPTT 40-50 seconds
Patients 11-15: IV heparin, target aPTT range 40-50 seconds
干预措施: heparin (Drug)
intravenous heparin
Patients 26-40: IV heparin, target range aPTT 50-60 seconds
干预措施: heparin (Drug)
Intravenous heparin
Patients 41-55 IV heparin, target aPTT range 60-70 seconds
干预措施: heparin (Drug)
sq heparin three times a day
Patients 1-10 will receive subcutaneous heparin three times a day
干预措施: heparin (Drug)
结局指标
主要结局
Incidence of major bleeding
时间窗: This outcome will be measured for an average of 30 days
Defined as:decrease in hemoglobin greater than 2g/dl and/or transfusion of 2 or more units of packed red blood cells. However, if there are obvious other reasons for bleeding, such as within 12 hours of major surgery, coagulopathy unrelated to heparin or an anatomical basis.
次要结局
未报告次要终点