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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hematologic Neoplasms; Disseminated Intravascular Coagulation; Solid Tumor Metastatic Cancer Advanced Cancer
• Intervention / Treatment: Biological: An additional volume of blood will be drawn as part of routine follow-up care

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Raphaël Clere-Jehl; Phone Number: +33 3 88 12 82 23; Email: raphael.clere@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67000
    • Hôpitaux Universitaires de Strasbourg
    • Contact: Raphaël Clere-Jehl; Phone Number: +33 3 88 12 82 23; Email: raphael.clere@chru-strasbourg.fr
    • Contact: Clere-Jehl; Email: raphael.clere@chru-strasbourg.fr
    • Principal Investigator: Raphaël Clere-Jehl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The populations studied are neoplasia carriers with coagulopathy defined by the association of thrombocytopenia (<100G/L) and increased INR (>1.2).

Adult patients hospitalized in Emergency Medicine, Intensive Care Medicine or Hepatobiliary and Digestive Surgery Service.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Biological: 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.
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.	Biological: 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.
Group 3: Control group (free of neoplastic pathology, with well-studied coagulopathy); Defined according to Sepsis-criteria	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasminogen measurement at D1 in hematologic malignancy, solid tumor and septic shock groups.	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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of various haemostasis markers	Measurement of platelet count, PT/INR, aPTT, fibrinogen, factor V, D-dimers, antithrombin III, factor VIII	Day 1, 3 and 7
Measurement of markers of fibrinolytic activity and its regulation	Assay of t-PA, u-PA, PAI-1, u-PAR, plasmin activity	Day 1, 3 and 7
Analysis of parameters closely associated with serum NET assays	Measurement of neutrophil fluorescence, circulating nucleosomes	Day 1, 3 and 7

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Raphaël Clere-Jehl, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Thrombophilia; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Disseminated Intravascular Coagulation
• Other Study ID Numbers: 9558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No