Assessment of Hemostatic Profile in Liver Cirrhosis

NCT ID: NCT04265508

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-11-01

Brief Summary

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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

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Conditions

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Coagulation Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Low MELD score

MELD score of 6 - 11

Assessment of hemostatic profile

Intervention Type 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)

High MELD score

MELD score of ≥ 17

Assessment of hemostatic profile

Intervention Type 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)

Interventions

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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)

Intervention Type OTHER

Other Intervention Names

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Thrombelastometry; impedance aggregometry

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goethe University

OTHER

Sponsor Role lead

Responsible Party

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Elisabeth H. Adam

Division Chief of Critical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universital Hospital Frankfurt / Main

Frankfurt am Main, Deutschland, Germany

Site Status

Countries

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Germany

Other Identifiers

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195/17

Identifier Type: -

Identifier Source: org_study_id

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