Assessment of Hemostatic Profile in 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).

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Key information

Conditions

Coagulation Disorder Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universital Hospital Frankfurt / Main

Frankfurt am Main, Deutschland, 60529, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of hemostatic profile

Other

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

Primary outcomes

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

Secondary outcomes

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)

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Feb 11, 2020
Registry last updated: Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed