Effects of Platelet Mimicking Nanoparticles in Patients With Cirrhosis

NCT06050993 | Completed

• 2 other identifiers: APHP2302492023 -A00064-41
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cirrhosis

Keywords

Hemostatics; Blood Coagulation Disorders; Liver Cirrhosis; Platelet Adhesiveness

Outcome Measures

Primary Outcomes (1)

• Area under the curve at 10 min of the T-TAS® 01 perfusion in PL chips

  One day

Secondary Outcomes (3)

• Time to reach a pressure of 10 kPa above baseline

  One day

• Time to reach a pressure of 60 kPa above baseline

  One day

• Correlations between laboratory results and perfusions' characteristics

  Through study completion, an average of 6 months

Study Arms (2)

Cirrhotic patients

Patients known to have a cirrhosis, with an invasive procedure scheduled at the Paul Brousse hospital

Other: 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

Other: Additional blood sampling at the same time and in addition of samplings already done for the patient's standard of care.

Interventions

Additional blood sampling at the same time and in addition of samplings already done for the patient's standard of care. OTHER

During the preoperative procedure scheduled at the Paul Brousse hospital, 3 additional blood tubes (total volume 12 ml) will be withdrawn in addition of samplings already done for the patient's standard of care.

Cirrhotic patients; Non-cirrhotic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients coming to the Paul Brousse hospital for a scheduled preoperative procedure.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Société Française d'Anesthésie et de Réanimation: collaborator
• CSL Behring: collaborator
• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Anaesthesia unit of the Hepatobiliary Center - Paul Brousse Hospital

Villejuif, 94800, France

Location

Related Publications (1)

• Abdoul J, Luc N, Joly BS, Jehl A, Blandinieres A, Adam F, Duhaut L, Aljhni R, Grimaldi L, Lenting PJ, Sen Gupta A, Denis CV, Roullet S. Total thrombus formation system exploration of primary hemostasis in cirrhotic patients. Res Pract Thromb Haemost. 2026 Jan 29;10(1):103370. doi: 10.1016/j.rpth.2026.103370. eCollection 2026 Jan.

  PMID: 41756538 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 additional citrate tubes (total volume : 9 ml) and 1 Benzylsulfonyl-D-Arg-Pro-4-amidinobenzylamide (BAPA) tube (total volume : 3 ml) will be withdrawn at the same time and in addition of those already withdrawn for the patient's standard of care. Plasma aliquots will be done from citrate tubes and frozen. Whole blood tube will be used on the same day of sampling.

MeSH Terms

Conditions

Liver Cirrhosis; Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: September 22, 2023
• Study Start: April 25, 2024
• Primary Completion: January 28, 2025
• Study Completion: January 28, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)