Role of Fibrinolytic Activity in Neoplastic Pathologies Complicated by Coagulopathy (NEO-COAG)

University Hospital, Strasbourg, France

Status: Not yet enrolling

Conditions: Hematologic Neoplasms; Solid Tumor Metastatic Cancer Advanced Cancer; Disseminated Intravascular Coagulation

Treatments: Biological: An additional volume of blood will be drawn as part of routine follow-up care

Study type: Observational

Funder types: Other

Identifiers

NCT07234630

9558

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

150 participants in 3 patient groups

Group 1: Hematological malignancies with large tumor masses

Description:

* 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.

Treatment:

Biological: An additional volume of blood will be drawn as part of routine follow-up care

Group 2: Locally advanced or metastatic solid tumors with DIC

Description:

* Prostatic adenocarcinoma * Malignant pancreatic or biliary tract tumor (cholangiocarcinoma), * Scheduled complex hepatobiliary carcinological surgery, * Metastatic adenocarcinoma of the digestive tract.

Treatment:

Biological: An additional volume of blood will be drawn as part of routine follow-up care

Group 3: Control group (free of neoplastic pathology, with well-studied coagulopathy)

Description:

Defined according to Sepsis-criteria

Treatment:

Biological: An additional volume of blood will be drawn as part of routine follow-up care