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COMPLETED
NCT06050993

Effects of Platelet Mimicking Nanoparticles in Patients With Cirrhosis

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: Exploration of Primary Haemostasis in Cirrhotic Patients With T-TAS System and Effects of Platelets Mimicking Nanoparticles

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2024-04-25

Completion Date

2025-01-28

Last Updated

2026-04-23

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

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

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preoperative procedure scheduled at the Paul Brousse hospital, 3 additional blood tubes (total volume 12 ml) will be withdrawn in addition of samplings already done for the patient's standard of care.

Locations (1)

Anaesthesia unit of the Hepatobiliary Center - Paul Brousse Hospital

Villejuif, France