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临床试验/NCT00550082
NCT00550082已完成不适用

Multi-Screen Electronic Alert for Venous Thromboembolism Prevention

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 880 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
880
试验地点
1
主要终点
Venous Thromboembolism and Bleeding Events

研究概览

简要总结

Evaluation of physician responses to BICS-Clinical Information 3-screen alerts that informs the clinician that his/her patient may be eligible for thromboprophylaxis.

详细描述

Background and Significance:

Scope of the Problem: VTE is the third most common cardiovascular disease (heart attack and stroke are more common) but is the most preventable medical problem among patients hospitalized with other illnesses. DVT often causes chronic venous insufficiency, a potentially disabling and painful condition that lowers the quality of life. Acute PE may cause death or disabling chronic thromboembolic pulmonary hypertension. After discharge from a short-term hospital stay, one study reported that the incidence of DVT was 48 per 100,000 and the incidence of PE (with or without DVT) was 23 per 100,000.9 In addition, the incidence of VTE increases dramatically with age.10-11 Clinical manifestations of DVT often include swelling, pain, and extremity discoloration and may lead to PE. Manifestations of PE may include dyspnea, pleuritic pain, cough, and hemoptysis or may be asymptomatic.12-13 The 28-day mortality rate for a first VTE event is alarmingly high, approximately 11%.14 In addition, 3-month mortality rates for PE have been reported as high as 17%.15 However, appropriate prophylaxis-using anticoagulants, mechanical measures, or both anticoagulants plus mechanical measures-can prevent most episodes of VTE16. For example, mechanical measures as simple as "low tech" and inexpensive graduated compression stockings can reduce VTE rates.16a, 16b, 16c

Burden to Patients: VTE is associated with complications including recurrence of DVT or PE, chronic thromboembolic pulmonary hypertension, death, or the subsequent development of post-thrombotic syndrome. The risk of VTE recurrence is greatest within 6-12 months after the first event and continues for at least 10 years,17 and is a risk factor for death after PE.18 The post-thrombotic syndrome can have devastating effects on the patients' quality of life and is associated with venous hypertension that may cause pain, edema, skin changes, varicose veins, and skin ulcers. Valve dysfunction, which can lead to venous hypertension, is most often caused by a previous DVT.19 The cumulative incidence of the development of postthrombotic syndrome after a VTE event is high: 17% at one year, 23% at 2 years, and 29% at 8 years, with 30% of these cases classified as severe.20

Burden to Society: Direct medical costs to the United States health care system related to VTE events and complications approximate at least $600 million annually. Bullano and colleagues21 estimate that managed care plans pay a median of $3,131 per incident DVT, $6,424 per incident PE, and $12,200 for a DVT plus PE combination event. A 2004 registry of 5,451 patients with ultrasound-confirmed DVT at 183 institutions in the United States revealed that DVT led to hospitalization in 80% of those diagnosed as outpatients. Those initially diagnosed with DVT as inpatients remained hospitalized for a median of 12 days.7

Role of computerized healthcare delivery systems:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized patients at Brigham and Women's Hospital from medical and surgical services who are 18 yrs old or older and are at a moderate to high risk for venous thromboembolism (VTE)

排除标准

  • 未提供

结局指标

主要结局

Venous Thromboembolism and Bleeding Events

时间窗: 90 Days

次要结局

  • Re-hospitalization(90 Days)
  • Mortality(30 Days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samuel Z.Goldhaber, MD

Director, VTE Research Group

Brigham and Women's Hospital

研究点 (1)

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