An observational study in Hematologic Neoplasms, Solid Tumor Metastatic Cancer Advanced Cancer and Disseminated Intravascular Coagulation, sponsored by University Hospital, Strasbourg, France. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by University Hospital, Strasbourg, France · Observational
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 :
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's planned enrollment of 150 is below the median of 186 across 326 observational studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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
* 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
* 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
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.
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
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
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
Analysis of parameters closely associated with serum NET assays
Measurement of neutrophil fluorescence, circulating nucleosomes
Time frame: Day 1, 3 and 7
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Strasbourg, France