Role of Fibrinolytic Activity in Neoplastic Pathologies Complicated by Coagulopathy

NCT ID: NCT07234630

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-02-29

Brief Summary

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

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: BIOLOGICAL

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. The total volume of blood collected at D1 and D7 was 18.5 mL (3 x 4 mL citrate tubes, 1 x 4 mL EDTA tube and 1 x 2.5 mL Paxgene tube). The volume of blood drawn at D3 was 16 mL (3 x 4 mL citrated tubes, one 4 mL EDTA tube).

Samples are immediately analyzed in the hematology/hemostasis laboratory for NETs and hemostasis, with the remaining portion of the tube centrifuged before plasma is frozen at -80°C for plasma analysis. The Paxgene tube can be used for non-identifying genetic analyses.

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.

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

Intervention Type: BIOLOGICAL

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. The total volume of blood collected at D1 and D7 was 18.5 mL (3 x 4 mL citrate tubes, 1 x 4 mL EDTA tube and 1 x 2.5 mL Paxgene tube). The volume of blood drawn at D3 was 16 mL (3 x 4 mL citrated tubes, one 4 mL EDTA tube).

Samples are immediately analyzed in the hematology/hemostasis laboratory for NETs and hemostasis, with the remaining portion of the tube centrifuged before plasma is frozen at -80°C for plasma analysis. The Paxgene tube can be used for non-identifying genetic analyses.

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

Defined according to Sepsis-criteria

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

Intervention Type: BIOLOGICAL

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. The total volume of blood collected at D1 and D7 was 18.5 mL (3 x 4 mL citrate tubes, 1 x 4 mL EDTA tube and 1 x 2.5 mL Paxgene tube). The volume of blood drawn at D3 was 16 mL (3 x 4 mL citrated tubes, one 4 mL EDTA tube).

Samples are immediately analyzed in the hematology/hemostasis laboratory for NETs and hemostasis, with the remaining portion of the tube centrifuged before plasma is frozen at -80°C for plasma analysis. The Paxgene tube can be used for non-identifying genetic analyses.

Interventions

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

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. The total volume of blood collected at D1 and D7 was 18.5 mL (3 x 4 mL citrate tubes, 1 x 4 mL EDTA tube and 1 x 2.5 mL Paxgene tube). The volume of blood drawn at D3 was 16 mL (3 x 4 mL citrated tubes, one 4 mL EDTA tube).

Samples are immediately analyzed in the hematology/hemostasis laboratory for NETs and hemostasis, with the remaining portion of the tube centrifuged before plasma is frozen at -80°C for plasma analysis. The Paxgene tube can be used for non-identifying genetic analyses.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raphaël Clere-Jehl

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Countries

France

Central Contacts

Raphaël Clere-Jehl

Role: CONTACT

raphael.clere@chru-strasbourg.fr

+33 3 88 12 82 23

Facility Contacts

Raphaël Clere-Jehl

Role: primary

raphael.clere@chru-strasbourg.fr

+33 3 88 12 82 23

Clere-Jehl

Role: backup

raphael.clere@chru-strasbourg.fr

Other Identifiers

9558

Identifier Type: -

Identifier Source: org_study_id