Clinical trial · Observational
Role of Fibrinolytic Activity in Neoplastic Pathologies Complicated by Coagulopathy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disseminated Intravascular Coagulation | — | UNRESOLVED | — |
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Solid Tumor Metastatic Cancer Advanced Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| An additional volume of blood will be drawn as part of routine follow-up care | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- 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.
- interventionNames
- Biological: An additional volume of blood will be drawn as part of routine follow-up care
- label
- 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.
- interventionNames
- Biological: An additional volume of blood will be drawn as part of routine follow-up care
- label
- Group 3: Control group (free of neoplastic pathology, with well-studied coagulopathy)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available