NCT07234630尚未招募不适用
Role of Fibrinolytic Activity in Neoplastic Pathologies Complicated by Coagulopathy
University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Plasminogen measurement at D1 in hematologic malignancy, solid tumor and septic shock groups.
研究概览
简要总结
The aim of this research is to measure fibrinolytic activity in neoplastic pathologies in order to provide preliminary data on which to base a future, larger-scale study to determine predictive markers of complication in order to improve patient management.
Primary purpose: measure plasminogen concentration on day 1 in subjects diagnosed with malignant hematological disease, solid tumors, or septic shock, with coagulopathy.
Secondary purpose:
- Estimate the difference in plasminogen concentration at D1 in patients with coagulopathy between subjects with a diagnosis of haematological malignancy and those with solid tumor
- Estimate the difference in plasminogen concentration at D1 in patients with coagulopathy between subjects with a diagnosis of haematological malignancy and those with septic shock
- Estimate the difference in plasminogen concentration on Day 1 in patients with coagulopathy between subjects with a diagnosis of solid tumor and those with septic shock.
In the 3 groups, subjects with a diagnosis of haematological malignancy, solid tumor, septic shock, presenting with coagulopathy:
- Evaluate the correlation between the concentration of circulating plasminogen active on Day 1 and the occurrence of a bleeding complication within 28 days of admission to critical care.
- Evaluate the correlation between the concentration of circulating plasminogen active on Day 1 and the occurrence of a thrombotic complication, within 28 days of admission to critical care.
- Evaluate the predictive performance of circulating active plasminogen concentration on Day 1 in the need for extra renal purification within 28 days of admission to critical care.
- Estimate the differences at each time point (D1, D3, D7) in haemostasis markers and markers of fibrinolytic activity and its regulation.
Assess the link between fibrinolytic activity and :
- The diagnosis of disseminated intravascular coagulation (DIC),
- The risk of haemorrhage
- Risk of organ failures
- Thrombotic risk
- Risk of organ failure
- Neutrophile activation and circulating NETs levels
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For all groups:
- •Age > 18 years
- •Patient hospitalized in Emergency Medicine, Intensive Care Medicine or Hematology/Oncology Intensive Care, Hematology/Oncology Service or Hepatobiliary and Digestive Surgery Service
- •Coagulopathy defined by the combination of thrombocytopenia (< 100 G/L) and increased INR (>1.2)
- •Group 1: Malignant hemopathies with large tumor masses:
- •Acute myeloblastic or lymphoblastic leukemia with leukocyte count (or blasts) >50G/L in peripheral blood, or
- •Lymphoma documented by tissue biopsy, with biological tumor lysis syndrome, diagnosed according to Cairo and Bishop criteria (3).
- •Group 2: Locally advanced or metastatic solid tumors with DIC:
- •Prostatic adenocarcinoma
- •Malignant pancreatic or biliary tract tumor (cholangiocarcinoma),
- •Scheduled complex hepatobiliary carcinological surgery,
- •Metastatic adenocarcinoma of the digestive tract.
- •Group 3: Control group (free of neoplastic pathology, with well-studied coagulopathy): Septic shock
排除标准
- •Patient under protective supervision (guardianship or curatorship)
- •Pregnant women
- •Patients weighing less than 50 kg
- •Patient already included in the study
- •Congenital hemostasis disorders
- •Active bleeding at the time of inclusion
- •Patient with cirrhosis
- •Patients receiving curative anticoagulation therapy
- •Patients with a spontaneous INR > 1.2 in a previous blood test in a context of fibrinolytic insufficiency
- •Each group is exclusive of the other, for example :
- •For Group 1 (Neoplastic pathologies): Presence of documented sepsis at the time of inclusion
研究组 & 干预措施
Group 1: Hematological malignancies with large tumor masses
- Acute myeloblastic or lymphoblastic leukemia with leukocyte count (or blasts) >50G/L in peripheral blood, or
- Lymphoma documented by tissue biopsy, with biological tumor lysis syndrome, diagnosed according to Cairo and Bishop criteria.
干预措施: An additional volume of blood will be drawn as part of routine follow-up care (Biological)
Group 2: Locally advanced or metastatic solid tumors with DIC
- Prostatic adenocarcinoma
- Malignant pancreatic or biliary tract tumor (cholangiocarcinoma),
- Scheduled complex hepatobiliary carcinological surgery,
- Metastatic adenocarcinoma of the digestive tract.
干预措施: An additional volume of blood will be drawn as part of routine follow-up care (Biological)
Group 3: Control group (free of neoplastic pathology, with well-studied coagulopathy)
Defined according to Sepsis-criteria
干预措施: An additional volume of blood will be drawn as part of routine follow-up care (Biological)
结局指标
主要结局
Plasminogen measurement at D1 in hematologic malignancy, solid tumor and septic shock groups.
时间窗: Day 1
The biological samples collected correspond to blood samples taken from venous or arterial catheters inserted at the time of admission as part of routine care.
次要结局
- Measurement of various haemostasis markers(Day 1, 3 and 7)
- Measurement of markers of fibrinolytic activity and its regulation(Day 1, 3 and 7)
- Analysis of parameters closely associated with serum NET assays(Day 1, 3 and 7)
研究者
研究点 (1)
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