Effects of Platelet Mimicking Nanoparticles in Patients With Cirrhosis (NCT06050993) | Clinical Trial Compass
CompletedNot Applicable
Effects of Platelet Mimicking Nanoparticles in Patients With Cirrhosis
France60 participantsStarted 2024-04-25
Plain-language summary
Haemostasis of cirrhotic patients is disturbed at different levels: primary haemostasis, coagulation and fibrinolysis, leading to a new haemostatic balance. Thrombocytopenia and thrombopathy are counterbalanced by elevation of Von Willebrand factor (VWF) and diminution of ADAMTS13 activity. Exploration of primary haemostasis is difficult in the laboratory, and non-interpretable in case of thrombocytopenia. Moreover, these tests are not performed under flow conditions. The T-TAS®01 system analyses the total haemostatic capacity in whole blood under shear stress, with chips coated with type 1 collagen. Platelets transfusion performs poorly in cirrhotic patients and is not recommended before invasive procedure. Platelets mimicking nanoparticles (PMNs) have been developed by Pr Sen Gupta (Case Western Reserve University, Cleveland, Ohio (OH), USA). PMNs have been proven to collaborate with platelets and enhance haemostasis in different shear conditions in vitro and in different models of haemorrhage in vivo. The assumption of this study is that the perfusions characteristics of cirrhotic patients in the T-TAS®01 system will be different from those of non-cirrhotic patients, and that platelets mimicking nanoparticles will improve these characteristics.
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:
* Adult patients who are beneficiaries of a social security scheme or beneficiaries entitled to it
* Patients followed for a cirrhotic pathology at the Paul Brousse hospital and benefiting from a scheduled anaesthesia consultation for a scheduled interventional or surgical procedure
* For non-cirrhotic patients: adult patients who are beneficiaries of a social security scheme or beneficiaries entitled to it, benefiting from a blood test scheduled as part of their usual preoperative care (patients in the hepatology or digestive surgery department operated on at the Paul Brousse hospital)
Exclusion Criteria:
* Patient not wishing to participate in the study
* Patient with a known haemostasis abnormality other than cirrhosis
* Patient on long-term antiplatelet or anticoagulant therapy
* Patient who has taken a non-steroidal anti-inflammatory drug within 5 days prior to the blood test
* Patients with thrombopathy of genetic origin
* Patient on estrogenic therapy
* Patient with cancer under treatment or treated in the last 6 months
* Patient on immunosuppressive or immunomodulatory therapy
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
Area under the curve at 10 min of the T-TAS® 01 perfusion in PL chips