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

Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01711957
• Other study ID #: EK-1487
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 18, 2012
• Last updated: October 23, 2012
• Start date: January 2008
• Est. completion date: January 2013

Study information

• Verified date: October 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complication
• Death

Intervention

Procedure:
• Liver transplantation
Standardized technique of liver transplantation Organ procurement follow the rules of the Swiss transplant society

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Department of Visceral Surgery and Transplantation	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient survival		3-year	No
Primary	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	No
Secondary	Primary graft non-function	Defined as death or retransplantation within the first postoperative week after exclusion of technical, immunological, and infectious causes	first postoperative week	No
Secondary	Delayed graft function	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	No