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

NCT01711957 | Unknown DMC

• 1 other identifier: EK-1487
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complication; Death

Keywords

Complications; Mortality; Liver transplantation; Platelet count; Survival

Outcome Measures

Primary Outcomes (1)

• Severe complication after liver transplantation

  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 Outcomes (2)

• Primary graft non-function

  first postoperative week

• Delayed graft function

  7 days after liver transplantation

Other Outcomes (1)

• Patient survival

  3-year

Study Arms (1)

Liver disease and liver transplantation

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

Procedure: Liver transplantation

Interventions

Liver transplantation PROCEDURE

Standardized technique of liver transplantation Organ procurement follow the rules of the Swiss transplant society

Also known as: Orthotopic liver transplantation (OLT), Cadaveric-donor liver transplantation

Liver disease and liver transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Department of Visceral Surgery and Transplantation

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

• Lesurtel M, Raptis DA, Melloul E, Schlegel A, Oberkofler C, El-Badry AM, Weber A, Mueller N, Dutkowski P, Clavien PA. Low platelet counts after liver transplantation predict early posttransplant survival: the 60-5 criterion. Liver Transpl. 2014 Feb;20(2):147-55. doi: 10.1002/lt.23759. Epub 2013 Nov 21.

  PMID: 24123804 DERIVED

MeSH Terms

Conditions

Death

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Mickael Lesurtel, M.D., PhD

  University of Zurich

  STUDY DIRECTOR

• Pierre-Alain Clavien, M.D., PhD

  University of Zurich

  STUDY CHAIR

• Dimitri A. Raptis, M.D., MSc

  University of Zurich

  PRINCIPAL INVESTIGATOR

• Emmanuel Melloul, M.D.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 23, 2012
• Study Start: January 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

CH (1)