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

Liver Transplantation Clinical Trial

— HITOLT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654848
• Other study ID #: TransplanTUM-1
• Secondary ID: HITafterOLT
• Status: Completed
• Phase: N/A
• First received: March 30, 2012
• Last updated: July 31, 2012
• Start date: January 2010
• Est. completion date: August 2011

Study information

• Verified date: July 2012
• Source: CHIR-Net
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heparin-induced Thrombocytopenia
• Liver Transplantation
• Thrombocytopenia
• Thrombocytosis

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar der TU München	Munich

Sponsors (2)

Lead Sponsor	Collaborator
CHIR-Net	University Medicine Greifswald

Country where clinical trial is conducted

Germany,