NCT03625726

Brief Summary

Cirrhosis is a condition in which the liver does not function properly due to long-term damage. This damage is characterized by the replacement of normal liver tissue by scar tissue. The liver carries out several necessary functions, including synthesis of proteins participating in blood coagulation process. Some of these proteins contribute to coagulation and others make blood more fluid. In healthy people there is a balance between the two. In cirrhotic patient, there is an imbalance inducing hypercoagulation (hypercoagulability state). Cirrhotic patients are so known to be at risk of vein thrombosis (for example portal vein thrombosis: clot in hepatic vein). Mechanisms leading to this imbalance are unclear. Studies need to be completed to improve patient's management. The EPCRs (Endothelial Protein C Receptor soluble) takes part in blood coagulation process. Previous studies have shown that blood levels of EPCRs are increased in patients with cirrhosis. The primary purpose of the study is to evaluate if the EPCRs could play a role in cirrhosis-associated hypercoagulability state.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

August 3, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

6 years

First QC Date

July 30, 2018

Last Update Submit

August 29, 2022

Conditions

Cirrhosis

Keywords

cirrhosishypercoagulabilitythrombin generation assaysoluble Endothelial Protein C Receptor

Outcome Measures

Primary Outcomes (1)

  • Thrombin generation assay (area under the curve/ Endogenous Thrombin Potential) with thrombomodulin.

    24 months

Secondary Outcomes (3)

  • Thrombin generation assay parameters : peak height

    24 months

  • Thrombin generation assay parameters : lag time

    24 months

  • Thrombin generation assay parameters : time to peak

    24 months

Study Arms (3)

patients with cirrhosis

EXPERIMENTAL

pathophysiology study, blood sample

Biological: Thrombin generation assay (in vitro)

healthy volunteers

PLACEBO COMPARATOR

pathophysiology study, blood sample

Biological: Thrombin generation assay (in vitro)

patients with hepatocellular carcinoma

PLACEBO COMPARATOR

pathophysiology study, blood sample

Biological: Thrombin generation assay (in vitro)

Interventions

Thrombin generation assay (in vitro)BIOLOGICAL

One blood sample.

healthy volunteerspatients with cirrhosispatients with hepatocellular carcinoma

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male, age 18 or older
  • Cirrhosis, defined by: prothombin time ≤ 70% +/- liver dysmorphism +/- Fibroscan \> 12.5 kPa +/- histology +/- portal hypertension associated with hepatocellular insufficiency
  • Cirrhosis associated with hepatitis B or C, or alcoholic liver disease, or non alcoholic steato hepatitis
  • Measurable portal flow by ultrasound doppler
  • Child Pugh score A,B or C, without acute infection or acute bleeding
  • Signed written informed consent
  • Affiliation to french social security system

You may not qualify if:

  • Known history of vein thrombosis
  • Known family history (in first-degree relative) of spontaneous thrombosis
  • Partial or complete portal system vein thrombosis
  • Uncontrolled infection after 7-day course of antibiotics
  • Anticoagulant intake
  • Hepatocellular carcinoma
  • Protected or deprived of liberty adult
  • Any medical or surgical history that could interfere with the study, as judged by the investigator
  • Blood transfusion within 7 days
  • Participation in a clinical trial for drug
  • Healthy volunteers
  • Male, age 18 or older
  • Body Mass Index between 18 and 30 kg/m2
  • Normal physical examination
  • Willing and able to comply with requirements of the study
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

RECRUITING

MeSH Terms

Conditions

FibrosisThrombophilia

Interventions

In Vitro Techniques

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Armand ABERGEL

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

04 73 75 49 63drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Model Details: Exploratory, cross-sectional, case-control pathophysiology study, based on ex vivo treatment of blood samples.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 10, 2018

Study Start

August 3, 2018

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

August 30, 2022

Record last verified: 2022-08

Locations

FR(1)