The Perioperative Value of Platelet Counts in Predicting Outcome After Liver Transplantation

October 23, 2012 updated by: Dimitri Aristotle Raptis, University of Zurich

Recent experimental and clinical studies have shown that platelets play a critical role in liver ischemia and regeneration. Thrombocytopenia, a frequent and potentially serious condition in liver transplantation (LT) recipients, was shown to be associated with postoperative morbidity and mortality after partial hepatectomy.

The investigators aim at evaluating whether postoperative low platelet counts are indicators of short- and long-term outcomes after liver transplantation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich, Department of Visceral Surgery and Transplantation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with end stage liver disease and/or primary liver tumor undergoing liver transplantation

Description

Inclusion Criteria:

  • Age >18 years old
  • End stage liver disease
  • Cadaveric-donor liver transplantation

Exclusion Criteria:

  • Age <18 years old
  • Pregnancy
  • Living-related liver transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Liver disease and liver transplantation
Patient with end stage liver disease and/or primary liver tumor undergoing liver transplantation
Procedure: Liver transplantation
Standardized technique of liver transplantation Organ procurement follow the rules of the Swiss transplant society
Other Names:
  • Orthotopic liver transplantation (OLT)
  • Cadaveric-donor liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe complication after liver transplantation
Time Frame: 90 days
The severity of complications will be graded according to the Clavien-Dindo classification by outcome. Grade III to V complications will be considered as severe.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary graft non-function
Time Frame: first postoperative week
Defined as death or retransplantation within the first postoperative week after exclusion of technical, immunological, and infectious causes
first postoperative week
Delayed graft function
Time Frame: 7 days after liver transplantation
Defined as the presence of at least one of the following parameter at 7 days after LT: serum bilirubin > 10 mg/dL and International Normalized Ratio (INR) >1.6 or Alanine aminotransferase serum level (ALT) >2000UI/L
7 days after liver transplantation

Other Outcome Measures

Outcome Measure
Time Frame
Patient survival
Time Frame: 3-year
3-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Study Director: Mickael Lesurtel, M.D., PhD, University of Zurich
  • Study Chair: Pierre-Alain Clavien, M.D., PhD, University of Zurich
  • Principal Investigator: Dimitri A. Raptis, M.D., MSc, University of Zurich
  • Principal Investigator: Emmanuel Melloul, M.D., University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

October 18, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (Estimate)

October 23, 2012

Study Record Updates

Last Update Posted (Estimate)

October 24, 2012

Last Update Submitted That Met QC Criteria

October 23, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-1487

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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