Bleeding of Unknown Cause, Insight Into a Multifactorial Bleeding Disorder: a Swiss Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 7
- 主要终点
- Fibrin clot polymerisation
研究概览
简要总结
The goal of this prospective cohort is to identified specific biological patterns in patients with a bleeding of unknown cause and to study the specific mechanisms of the bleeding disorder for each subset of patients.
详细描述
Patients with bleeding of unknown cause are included. At baseline, blood will be drawn to evaluate the hemostatic profile. Findings are compared to a control group of healthy individuals. Patients and controls are followed for 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Man with ISTH BAT>
- •If the calculated score includes a surgical bleeding, then two other items of the score should be >0
- •Woman with ISTH BAT >5 points. If the calculated score includes a surgical or a postpartum bleeding, then two other items of the score should be >0
排除标准
- •Ongoing pregnancy
- •Intake of antithrombotic treatment or non-steroidal anti-inflammatory drugs for least 10 days at time of blood collection
- •Intake of antifibrinolytic or blood product administration (factor concentrate, frozen fresh plasma, prothrombin complex concentrate) for least 14 days before blood collection
- •Active cancer (defined as cancer diagnosis within the last five years or treatment within the two last years before study inclusion)
- •Active autoimmune disease
- •Active chronic inflammatory disease
- •Severe liver disease (cirrhosis > Child A)
- •Renal insufficiency stage 3
- •Active or recent infection (within the last 30 days)
- •Recent hospitalization (<3 months)
- •Recent surgery (<3 months)
- •Recent trauma requiring medical intervention (<3 months)
结局指标
主要结局
Fibrin clot polymerisation
时间窗: At inclusion
maximal absorption (optical density)
Fibrin clot permeability
时间窗: At inclusion
darcy coefficient (ks, cm2)
Fibrinolysis
时间窗: At inclusion
Clot lysis time (min)
Thrombin generation
时间窗: At inclusion
Endogenous thrombin potential (ETP, nM x min)
Coated platelets
时间窗: At inclusion
Absolute number of coated platelets
次要结局
- Fibrinogen gamma' levels(At inclusion)
- Clot retraction(At inclusion)
- Major bleeding episodes(Three years)
- Scan electron microscopy(At inclusion)
- Non-major bleeding episodes(Three years)
- Health related quality of life(three years)
- International Society Thrombosis Hemostasis Bleeding assessment tool(three years)
- Plasmin generation(At inclusion)
- Fibrin clot formation (thrombodynamics)(At inclusion)
研究者
Casini Alessandro
Principal investigator
University Hospital, Geneva