Assessment of Hemostatic Profile in Liver Cirrhosis

Completed

• Conditions: Coagulation Disorder
• Interventions: Other: Assessment of hemostatic profile

• Registration Number: NCT04265508
• Lead Sponsor: Goethe University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-11-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-08
• Study First Submitted QC: 2020-02-08
• Last Update Submitted: 2020-02-10
• Study First Posted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low MELD score	Assessment of hemostatic profile	MELD score of 6 - 11
High MELD score	Assessment of hemostatic profile	MELD score of ≥ 17

Primary Outcome Measures

Name	Time	Method
Aggregation of platelets	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 Outcome Measures

Name	Time	Method
Viscoelastic measurements	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)

Trial Locations

Locations (1)

Universital Hospital Frankfurt / Main; 🇩🇪 Frankfurt am Main, Deutschland, Germany