Effects of Platelet Mimicking Nanoparticles in Patients With Cirrhosis
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 60 people enrolled
- Started
- 25 Apr 2024
- Ended
- 28 Jan 2025
- Type of study
- Observational, 2 groups
- Treatments tested
- Additional blood sampling at the same time and in addition of samplings already done for the patient's standard of care.
- Record updated
- 23 April 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
- Patient on estrogenic therapy
- Patient on immunosuppressive or immunomodulatory therapy
- Patient with cancer under treatment or treated in the last 6 months
- Patient not wishing to participate in the study
- Patient with a known haemostasis abnormality other than cirrhosis
- Patients with thrombopathy of genetic origin
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Cirrhotic patients
Patients known to have a cirrhosis, with an invasive procedure scheduled at the Paul Brousse hospital
Treatment: Additional blood sampling at the same time and in addition of samplings already done for the patient's standard of care.
- Non-cirrhotic patients
Patients without cirrhosis, with an invasive procedure scheduled at the Paul Brousse hospital
Treatment: Additional blood sampling at the same time and in addition of samplings already done for the patient's standard of care.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Exploration of Primary Haemostasis in Cirrhotic Patients With T-TAS System and Effects of Platelets Mimicking Nanoparticles
- Record updated
- 23 April 2026