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Effects of Platelet Mimicking Nanoparticles in Patients With Cirrhosis

NCT06050993 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-04-23

No results posted yet for this study

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

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preoperative procedure scheduled at the Paul Brousse hospital, 3 additional blood tubes (total volume 12 ml) will be withdrawn in addition of samplings already done for the patient's standard of care.

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Société Française d'Anesthésie et de Réanimation

    collaborator OTHER

  • CSL Behring

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-25
Primary Completion
2025-01-28
Completion
2025-01-28

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06050993 on ClinicalTrials.gov