NCT01654848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

1.6 years

First QC Date

March 30, 2012

Last Update Submit

July 31, 2012

Conditions

Heparin-induced ThrombocytopeniaLiver Transplantation

Keywords

liver transplantationthrombocytesheparin-induced thrombocytopeniamultivariate analysis of associated factors of HIT 2 after OLTlaboratory investigations of HIT-antibodies

Study Arms (1)

orthotopic Liver Transplantation

consecutive inclusion of all recipients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • patient's refusal to participate in prospective observation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar der TU München

Munich, D-81675, Germany

Location

Study Officials

  • Volker Assfalg, MD

    Klinikum rechts der Isar, Dept. of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2012

First Posted

August 1, 2012

Study Start

January 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

DE(1)