International Prospective Registry for the Diagnosis and Management of Disseminated Intravascular Coagulation in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- disseminated intravascular coagulation
研究概览
简要总结
Objectives: to evaluate the current diagnostic and therapeutic approaches for sepis-associated disseminated intravascular coagulation (DIC) in a large prospective registry.
Design: prospective, multicenter, international registry. Study population: patients 18 years or older with severe infection to be potentially associated with DIC will be eligible for the study. The clinical visits and monitoring of the patients will follow local routine practices. No specific imaging tests or laboratory evaluations will be required and patients will be evaluated and treated according to local policy. All the involved centers will be asked to update information on included patients at 2, 4, 6, 8, 10 and 28 days after severe infection diagnosis.
Study outcomes: The primary outcome of the study is the development of DIC. Secondary outcomes are thrombotic (arterial and venous) and bleeding events, overall mortality at 28 days.
Study sample, feasibility, and analysis plan: We plan to enroll a minimum of 1000 patients.
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
- 否
入选标准
- •admission to the intensive care unit
- •18 years or older
- •AND one of the following conditions:
- •sepsis/severe infection
- •solid tumor
- •hematological malignancy
- •obstetric complications
- •acute pancreatitis
排除标准
- •<18 years
结局指标
主要结局
disseminated intravascular coagulation
时间窗: 28 days
occurence of disseminated intravascular coagulation: Japanese Association for Acute Medicine DIC score \>3 points (range 0-8)points items scored: inflammatory response, platelet count, prothrombin time, fibrinogen degradation products
次要结局
- Arterial thromboembolic events(28 days)
- mortality(28 days)
- venous thromboembolic events(28 days)
- Major and clinically-relevant non-major bleeding(28 days)
研究者
Marcella Muller
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)