Evaluation of the Impact of an Expert Opinion During the Management of Patients With Severe Bleeding on Oral Anticoagulants.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 30
- 主要终点
- Effectiveness of bleeding management
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate the impact of an expert opinion during the management of patients with severe bleeding on oral anticoagulants. The main question it aims to answer is :
• Does an expert help of decision during the management of patients with severe bleeding is superior to classic management ? The centers will be randomized in one of the two groups : control group and interventional group.
Patients will be followed for 3 months. At their inclusion they will be managed in conformity of the randomisation of their center.
They will be followed at hour 0 + 6 , H0+24 and at the end of hospitalization. After 3 months, they will be called to assess the occurrence of thrombotic events ou hemorrhage complications.
Researchers will compare the classic management versus the management with an expert opinion to see if the expert opinion is superior to classic management.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major patient treated with oral anticoagulants, admitted in an emergency department
- •For suspected major bleeding defined according to the criteria of the International Society of Thrombosis and Haemostasis
- •Able to give informed consent to participate in research or, in the event of an emergency, to take charge of a reference person
- •Affiliated to a Social Security scheme.
排除标准
- •Pregnant or breastfeeding women
- •Patient under guardianship, curatorship or safeguard of justice
- •Administration within the last 24 hours of parenteral anticoagulant.
- •Refusal to participate
结局指标
主要结局
Effectiveness of bleeding management
时间窗: Hour 24
The effectiveness of the management of bleeding will be evaluated with a rate of compliance with the recommendations in the event of major bleeding under oral anticoagulants
次要结局
- Rate of new bleeding(Inclusion + 3 months)
- Hemostatic efficacy rate(Hour 24)
- Specific mortality rate related to haemorrhage(Inclusion + 3 months)
- Changes in haemostasis values(Hour 6)
- Deadlines for implementing a reversion(Hour 24)
- Thromboembolic events(Inclusion + 3 months)
- Mortality rate all causes(Inclusion + 3 months)
- Duration of hospital stay(Inclusion + 3 months)
- Rate of avoided and avoidable reversions(Hour 24)