Role of Fibrinolytic Activity in Neoplastic Pathologies Complicated by Coagulopathy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

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

    Biological/Vaccine

    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.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Group 1: Hematological malignancies with large tumor masses1 intervention
Group B: Group 2: Locally advanced or metastatic solid tumors with DIC1 intervention
Group C: Group 3: Control group (free of neoplastic pathology, with well-studied coagulopathy)1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1

Secondary outcomes

1

Measurement of various haemostasis markers

Measurement of platelet count, PT/INR, aPTT, fibrinogen, factor V, D-dimers, antithrombin III, factor VIII

Time frame
Day 1, 3 and 7
2

Measurement of markers of fibrinolytic activity and its regulation

Assay of t-PA, u-PA, PAI-1, u-PAR, plasmin activity

Time frame
Day 1, 3 and 7
3

Analysis of parameters closely associated with serum NET assays

Measurement of neutrophil fluorescence, circulating nucleosomes

Time frame
Day 1, 3 and 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: