Efficacy of Low Dose Intravenous Heparin in Preventing Thromboembolism in the SICU.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Development of DVT (Deep Vein Thrombosis)
研究概览
简要总结
This study plans to learn more about what is the best treatment to prevent blood clots in patients in intensive care units (ICU's). The investigators know that patients who are in ICU's have a higher than normal risk of getting blood clots in the veins of their arms or legs. This can be very dangerous as the clot may move into the lungs. To prevent this, the standard treatment is to give low dose heparin subcutaneously 3 times a day (usually 5000 units at each dose). In this study the investigators are randomizing patients to receive either standard of care or low dose intravenous heparin in a continuous infusion.
详细描述
Macro- and micro-thrombosis both contribute significantly to morbidity and mortality in the surgical intensive care unit. Pulmonary embolism (PE) is a common and preventable cause of death in critically ill patients, with a mortality rate of up to 10%. Up to 95% of cases of PE originate from deep venous thrombosis (DVT). There are multiple pharmacologic and non-pharmacologic methods of DVT prophylaxis.The current standard of care in thromboprophylaxis in the surgical intensive care unit (SICU) at the University of Colorado Hospital is low-dose subcutaneous heparin (SCH). However, there is little evidence that this is the optimal prophylactic treatment. In fact, a database search of ICD-9 diagnoses made in 2005 suggests that the incidence of DVT in SICU patients, the majority who receive subcutaneous heparin, is approximately 7%. Surgical ICU patients are at high risk of developing DVT during their hospital stay and likely need more aggressive anticoagulation. Intravenous heparin, given at a low dose and titrated to a measurable endpoint PTT (partial thromboplastin time), may offer several benefits over the current standard of care, subcutaneous heparin. This method of treatment would offer more aggressive anticoagulation and allow dosage to be adjusted frequently based on each patient's changing coagulation status.
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
- None
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
- •A signed informed consent;
- •Age between 18 and 80 years
- •The patient is admitted to the surgical intensive care unit at the University of Colorado Hospital
排除标准
- •Predicated SICU stay less than 5 days;
- •Pregnancy;
- •Breast feeding;
- •Initial platelet count < 30,000;
- •Currently eligible for treatment of thromboembolism;
- •Prior organ transplant;
- •Cardiopulmonary bypass within previous 30 days;
- •Advanced directive precluding participation;
- •Already receiving pharmacologic agent for DVT prophylaxis;
- •Prior diagnosis of heparin-induced thrombocytopenia;
- •Heparin allergy
研究组 & 干预措施
continuous low dose intravenous heparin infusion
titrated to a PTT of 40-45
干预措施: low dose intravenous heparin (LDIVH) (Drug)
subcutanous heparin 5000 units 3 times/day
standard of care
干预措施: Heparin (Drug)
结局指标
主要结局
Development of DVT (Deep Vein Thrombosis)
时间窗: from start of study intervention to 6 months
In the first 70 patients, screening for DVT by ultrasound will occur on study days 0 and 5. After day 5 and for all remaining subjects, DVT will be diagnosed according to standard of care by the attending physician. Incidences of new DVT will be recorded daily until the patient is discharged from the hospital, or for a maximum of 28 days. DVT diagnosis will also be collected at 6 months from the primary care physician's office or the patient's household.
次要结局
- Development of PE's; Sepsis(up to 28 days post study intervention start)