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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:
In the 3 groups, subjects with a diagnosis of haematological malignancy, solid tumor, septic shock, presenting with coagulopathy:
Assess the link between fibrinolytic activity and :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Hematological malignancies with large tumor masses |
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| Group 2: Locally advanced or metastatic solid tumors with DIC |
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| Group 3: Control group (free of neoplastic pathology, with well-studied coagulopathy) | Defined according to Sepsis-criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| An additional volume of blood will be drawn as part of routine follow-up care | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
For all groups:
Group 1: Malignant hemopathies with large tumor masses:
Group 2: Locally advanced or metastatic solid tumors with DIC:
Group 3: Control group (free of neoplastic pathology, with well-studied coagulopathy): Septic shock
Exclusion Criteria:
For Group 1 (Neoplastic pathologies): Presence of documented sepsis at the time of inclusion
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raphaël Clere-Jehl | Contact | +33 3 88 12 82 23 | raphael.clere@chru-strasbourg.fr |
| Name | Affiliation | Role |
|---|---|---|
| Raphaël Clere-Jehl | Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg | Strasbourg | 67000 | France |
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|
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 |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D004211 | Disseminated Intravascular Coagulation |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001778 | Blood Coagulation Disorders |
| D006474 | Hemorrhagic Disorders |
| D019851 | Thrombophilia |
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