Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients (HITOLT)

This study has been completed.

Sponsor:

Collaborator:

University Medicine Greifswald

Information provided by (Responsible Party):

CHIR-Net

ClinicalTrials.gov Identifier:

NCT01654848

First received: March 30, 2012

Last updated: July 31, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 30, 2012

Last Updated Date

July 31, 2012

Start Date ^ICMJE

January 2010

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT01654848 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients

Official Title ^ICMJE

Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients: a Prospective Multivariate Analysis of Prognostic Factors and Haemostaseological Findings

Brief Summary

In a prospective observational study the incidence of Heparin-induced Thrombocytopenia (HIT) Type 2 after orthotopic liver transplantation, associated factors, and hemostaseological findings in thrombocytes and anti-body patterns is going to be investigated.

Detailed Description

The investigators examined the frequency of anti-PF4/heparin antibodies (IgG/M/A; EIA) and their functional activity (HIPA) in 38 whole organ deceased donor liver transplant recipients. Additionally, demographic, clinical, donor- and recipient-specific parameters and laboratory findings (ALAT, ASAT, cholinesterase) were investigated.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Biospecimen

Sampling Method

Non-Probability Sample

Study Population

consecutive livertransplant recipients of our transplant center, organ allocation via Eurotransplant Foundation, Leiden, The Netherlands; Laboratory investigations performed at the Abteilung für Transfusionsmedizin am Institut für Immunologie und Transfusionsmedizin der Universitätsmedizin Greifswald, Greifswald, Germany

Condition ^ICMJE

Heparin-induced Thrombocytopenia
Liver Transplantation

Intervention ^ICMJE

Study Group/Cohort (s)

orthotopic Liver Transplantation

consecutive inclusion of all recipients

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

all consecutive liver transplant recipients between 01/2010 and 08/2011 who
were transplanted at our center after allocation of a liver graft via Eurotransplant

Exclusion Criteria:

patient's refusal to participate in prospective observation

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01654848

Other Study ID Numbers ^ICMJE

TransplanTUM-1, HITafterOLT

Has Data Monitoring Committee

Responsible Party

CHIR-Net

Study Sponsor ^ICMJE

CHIR-Net

Collaborators ^ICMJE

University Medicine Greifswald

Investigators ^ICMJE

Principal Investigator:

Volker Assfalg, MD

Klinikum rechts der Isar, Dept. of Surgery

Information Provided By

CHIR-Net

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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