Assessment of Hemostatic Profile in Liver Cirrhosis

February 10, 2020 updated by: Elisabeth H. Adam, Goethe University

Assessment of Hemostatic Profile in Patients With Mild to Advanced Liver Cirrhosis

Our study included both in- and outpatients suffering from liver cirrhosis attending the out- and inpatient care of the department of hepatology. Demographic and biochemical data as well as medical history including cause of liver cirrhosis, end stage kidney failure and medication with anticoagulants were recorded. To assess the hemostatic profile, platelet function was analyzed by multiple electrode aggregometry (MEA) using Multiplate (ADP-, ASPI- and TRAP-test) and thrombelastometry using ROTEM (EXTEM, INTEM, FIBTEM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Deutschland
      • Frankfurt am Main, Deutschland, Germany, 60529
        • Universital Hospital Frankfurt / Main

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients attending the in- and outpatient care of the department of hepatology between 12/2017 and 05/2018 meeting the inclusion criteria were offered to participate in the present study. Inclusion criteria were liver cirrhosis and age of ≥ 18 years. Furthermore, a platelet count of at least 70 x103/µL was mandatory to ensure adequate measurement of MEA using the Multiplate analyzer. Patients were excluded when given a platelet concentrate three weeks prior to inclusion or in case of pregnancy.

Description

Inclusion Criteria:

  • liver cirrhosis
  • age of ≥ 18 years
  • platelet count of at least 70 / nl

Exclusion Criteria:

  • transfusion of platelet concentrate three weeks prior to inclusion
  • pregnancy
  • age < 18 years
  • missing informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low MELD score
MELD score of 6 - 11
Other: Assessment of hemostatic profile
To assess the hemostatic profile, platelet function was analyzed by multiple electrode aggregometry (MEA) using Multiplate (ADP-, ASPI- and TRAP-test) and thrombelastometry using ROTEM (EXTEM, INTEM, FIBTEM)
Other Names:
  • Thrombelastometry; impedance aggregometry
High MELD score
MELD score of ≥ 17
Other: Assessment of hemostatic profile
To assess the hemostatic profile, platelet function was analyzed by multiple electrode aggregometry (MEA) using Multiplate (ADP-, ASPI- and TRAP-test) and thrombelastometry using ROTEM (EXTEM, INTEM, FIBTEM)
Other Names:
  • Thrombelastometry; impedance aggregometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aggregation of platelets
Time Frame: Venous blood was collected via a cannula inserted into a cubital vein. Platelet function was measured by MEA using the Multiplate analyzer 15min after blood draw and after activation with commercially available standard reagents
AUC of impedance aggregometry using multiple electrode aggregometry
Venous blood was collected via a cannula inserted into a cubital vein. Platelet function was measured by MEA using the Multiplate analyzer 15min after blood draw and after activation with commercially available standard reagents

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viscoelastic measurements
Time Frame: Venous blood was collected via a cannula inserted into a cubital vein. Thrombelastometric assays were performed 15min after blood draw.
Viscoelastic measurements of ROTEM assays (EXTEM, INTEM, FIBTEM)
Venous blood was collected via a cannula inserted into a cubital vein. Thrombelastometric assays were performed 15min after blood draw.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goethe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

February 8, 2020

First Submitted That Met QC Criteria

February 8, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 195/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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