Role of Fibrinolytic Activity in Neoplastic Pathologies Complicated by Coagulopathy (NCT07234630) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Role of Fibrinolytic Activity in Neoplastic Pathologies Complicated by Coagulopathy
France150 participantsStarted 2026-01
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 othe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasminogen measurement at D1 in hematologic malignancy, solid tumor and septic shock groups.