About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Acute myeloblastic or lymphoblastic leukemia with leukocyte count (or blasts) >50G/L in peripheral blood, or
Disqualifiers
Patient under protective supervision (guardianship or curatorship)
Pregnant women
Patients weighing less than 50 kg
Patient already included in the study
Trial 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.
Trial design
Case-control
Prospective
Treatments tested in this trial
An additional volume of blood will be drawn as part of routine follow-up care
Biological/VaccineThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Measurement of various haemostasis markers
Measurement of platelet count, PT/INR, aPTT, fibrinogen, factor V, D-dimers, antithrombin III, factor VIII
Measurement of markers of fibrinolytic activity and its regulation
Assay of t-PA, u-PA, PAI-1, u-PAR, plasmin activity
Analysis of parameters closely associated with serum NET assays
Measurement of neutrophil fluorescence, circulating nucleosomes
Sponsors and contacts
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