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
  Purpose

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
Heparin-induced Thrombocytopenia
Liver Transplantation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by CHIR-Net:

Enrollment: 39
Study Start Date: January 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
orthotopic Liver Transplantation
consecutive inclusion of all recipients

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654848

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

No publications provided

Responsible Party: CHIR-Net
ClinicalTrials.gov Identifier: NCT01654848     History of Changes
Other Study ID Numbers: TransplanTUM-1, HITafterOLT
Study First Received: March 30, 2012
Last Updated: July 31, 2012
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014