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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01654848
Recruitment Status : Completed
First Posted : August 1, 2012
Last Update Posted : August 1, 2012
University Medicine Greifswald
Information provided by (Responsible Party):

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.

Condition or disease
Heparin-induced Thrombocytopenia Liver Transplantation

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 : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients: a Prospective Multivariate Analysis of Prognostic Factors and Haemostaseological Findings
Study Start Date : January 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

orthotopic Liver Transplantation
consecutive inclusion of all recipients

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01654848

Klinikum rechts der Isar der TU München
Munich, Germany, D-81675
Sponsors and Collaborators
University Medicine Greifswald
Principal Investigator: Volker Assfalg, MD Klinikum rechts der Isar, Dept. of Surgery

Responsible Party: CHIR-Net Identifier: NCT01654848     History of Changes
Other Study ID Numbers: TransplanTUM-1
HITafterOLT ( Other Identifier: TransplanTUM )
First Posted: August 1, 2012    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by CHIR-Net:
liver transplantation
heparin-induced thrombocytopenia
multivariate analysis of associated factors of HIT 2 after OLT
laboratory investigations of HIT-antibodies

Additional relevant MeSH terms:
Blood Platelet Disorders
Hematologic Diseases
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action