Assessment of Hemostatic Profile in Liver Cirrhosis

Coagulation Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265508
• Other study ID #: 195/17
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: February 2020
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• Hemostatic Disorders
• Liver Cirrhosis

Intervention

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)

Locations

Country	Name	City	State
Germany	Universital Hospital Frankfurt / Main	Frankfurt am Main	Deutschland

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aggregation of platelets	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	Viscoelastic measurements	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.