Efficacy of the Use of Risk Scores in Reducing Important Clinical Outcomes in Hospitalized Medical Ill Patients: the RICO Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,878
- 试验地点
- 35
- 主要终点
- The percentage of patients with major complications at a 90-day follow-up
研究概览
简要总结
FADOI (Italian Scientific Society of Hospital Internal Medicine) has planned to promote a multicenter cluster-randomized controlled clinical study in order to evaluate the effects of a systematic assessment of patients by using the Padua prediction score and the IMPROVE Bleeding score vs clinical judgement on the use of antithrombotic prophylaxis and clinical outcomes (thromboembolic and hemorrhagic events).
详细描述
The most recent guidelines suggest the use of prophylaxis in patients with a high thromboembolic risk, while taking into account the risk of bleeding.
It is known that patients admitted for acute pathology have an eight-fold higher incidence of thromboembolic events than the general population.
The Padua Prediction Score (PPS) is currently considered the best score available for the evaluation of thromboembolic risk in hospitalized patients, while the IMPROVE score was developed and validated for the assessment of bleeding risk in the same population of hospitalized patients.
In a recent study, data from the real world showed us how many of the patients admitted in Internal Medicine were at high thrombotic risk according to PPS and almost 90% of these were simultaneously at low hemorrhagic risk according to the IMPROVE score: in these patients pharmacological prophylaxis could therefore be prescribed during a safe stay.
Until now only a small prospective monocentric quasi-randomized study has shown that the use of systematic PPS reduces the incidence of thromboembolic events (symptomatic and non-symptomatic) upon discharge, compared to clinical judgment alone.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Hospitalized for any cause in Internal Medicine
- •Signature of informed consent
排除标准
- •Expected hospital stay < 48 h
- •Any indication for anticoagulant therapy
- •Life expectancy < 90 days
研究组 & 干预措施
Patients with the Padua and IMPROVE Bleeding scores
A number of centres will be randomized to systematically evaluate all eligible patients with the Padua and IMPROVE Bleeding scores within 48 h after hospitalization.
干预措施: Application of Padua and IMPROVE Bleeding scores (Other)
Patients will be evaluated according to clinical judgment only
A number of centres will be randomized to the Control arm of the study, in which patients will be evaluated for their thrombotic and hemorrhagic risk according to clinical judgment only.
结局指标
主要结局
The percentage of patients with major complications at a 90-day follow-up
时间窗: 3 month from the discharge
The percentage of patients with major complications (death, venous thromboembolism, major bleeding) at a 90-day follow-up in the group of patients who will be evaluated by means of the Padua and IMPROVE Bleeding scores vs those evaluated according to clinical judgment only
次要结局
- Clinical outcomes at hospital discharge(Time of hospitalization until discharge, up to 5 weeks)
- Number of patients with antithrombotic prophylaxis during hospital stay and at discharge.(Time of hospitalization until discharge, up to 5 weeks)