跳至主要内容
临床试验/NCT01056978
NCT01056978已完成不适用

Predictive Factors for Major Bleeding Risk in Patients Admitted in a Palliativecare Unit - Etude RHESO - Etude Monocentrique

Centre Hospitalier Universitaire de Saint Etienne20 个研究点 分布在 1 个国家目标入组 1,230 人开始时间: 2010年4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
1,230
试验地点
20
主要终点
The primary outcome is the symptomatic occurrence of major and clinical relevant bleeding during the three months study period.

研究概览

简要总结

Even if most patients in palliative care units presented with well-recognized risks factors of venous thromboembolism (VTE) (eg: active cancer, bed rest, previous history of venous thrombosis), the incidence of VTE in palliative setting is unknown. By consequence, the efficacy and safety of antithrombotic prophylaxis in such a population is not established. Indeed, patients admitted in palliative care units were not included in trials evaluating the potential effect of antithrombotic drugs in regard to their poor prognosis at short term. In addition, the main role of prophylaxis is to prevent sudden death from pulmonary emboli and is thus a life prolonging therapy which is viewed as counterintuitive to palliative care philosophy and inappropriate on grounds of futility. Nevertheless, the current use of Low Molecular Weight Heparin in palliative care units seems to increase particularly in patients with advanced malignancy. The identification of high hemorrhagic risks in palliative care patients could help the decision of antithrombotic prophylaxis initiation. For this, the investigators conducted a multicenter prospective longitudinal study.

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

  • admitted in a palliative care unit for a cancer, a pulmonary, a cardiac or a neurologic advanced disease

排除标准

  • life prognosis less than 48 hours
  • patients treated with curative doses of antithrombotic therapy
  • patients with follow up of 3 months is not possible

结局指标

主要结局

The primary outcome is the symptomatic occurrence of major and clinical relevant bleeding during the three months study period.

时间窗: 3 month

次要结局

  • Incidence of venous thomboembolic symptomatic disease(3 month)
  • Predictive factors for major bleeding(3 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (20)

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