Assessment of Hemostatic Profile in Liver Cirrhosis
1 other identifier
observational
67
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 8, 2020
CompletedFirst Posted
Study publicly available on registry
February 11, 2020
CompletedFebruary 12, 2020
February 1, 2020
5 months
February 8, 2020
February 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Viscoelastic measurements
Venous blood was collected via a cannula inserted into a cubital vein. Thrombelastometric assays were performed 15min after blood draw.
Study Arms (2)
Low MELD score
MELD score of 6 - 11
High MELD score
MELD score of ≥ 17
Interventions
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)
Eligibility Criteria
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.
You may qualify if:
- liver cirrhosis
- age of ≥ 18 years
- platelet count of at least 70 / nl
You may not qualify if:
- pregnancy
- age \< 18 years
- missing informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universital Hospital Frankfurt / Main
Frankfurt am Main, Deutschland, 60529, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division Chief of Critical Care
Study Record Dates
First Submitted
February 8, 2020
First Posted
February 11, 2020
Study Start
December 1, 2017
Primary Completion
May 1, 2018
Study Completion
November 1, 2018
Last Updated
February 12, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share