NCT02761109

Brief Summary

Incidence and risk factors for renal, cardiovascular and pulmonary complications after liver transplantation are not well defined. Blood products requirement is an important aspect of orthotropic liver transplantation (OLTx) management and has a great impact on patient's outcome. Transfusions of blood products increase perioperative complications and reduce graft and patients survival. The primary endpoint of the study is to evaluate the incidence of renal complication during ICU stay after liver transplantation using RIFLE criteria; secondary endpoint is to evaluate the incidence of cardiovascular and pulmonary complications. In addition patients' survival and the relationship between blood components use with the development of post-operative complications are evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

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, 2011

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

9 years

First QC Date

April 21, 2016

Last Update Submit

January 9, 2020

Conditions

Liver TransplantationPostoperative Renal ComplicationPostoperative Pulmonary ComplicationPostoperative Cardiovascular ComplicationBlood Components Transfusion

Outcome Measures

Primary Outcomes (1)

  • Incidence of renal complication after liver transplantation

    The primary endpoint of the study is to evaluate the incidence of renal complication during ICU stay after liver transplantation using RIFLE criteria

    At 72 post operative hours

Secondary Outcomes (3)

  • Incidence of cardiovascular complication after liver transplantation

    During ICU length of stay, an average of 4 days.

  • Incidence of pulmonary complication after liver transplantation

    During ICU length of stay, an average of 4 days.

  • Number of patients alive after liver transplantation that required blood components transfusion

    At 1 year and at 3 years after liver transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients 18 years old or more undergoing liver transplantation

You may qualify if:

  • years old or more

You may not qualify if:

  • Age less than 18 years;
  • Liver transplantation living related donor;
  • Retransplantation;
  • combined transplantation;
  • fulminant hepatic failure;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica di Anestesia, rianimazione e terapia intensiva

Udine, 33100, Italy

Location

Related Publications (5)

  • Watt KD, Pedersen RA, Kremers WK, Heimbach JK, Charlton MR. Evolution of causes and risk factors for mortality post-liver transplant: results of the NIDDK long-term follow-up study. Am J Transplant. 2010 Jun;10(6):1420-7. doi: 10.1111/j.1600-6143.2010.03126.x. Epub 2010 May 10.

    PMID: 20486907RESULT

  • Barri YM, Sanchez EQ, Jennings LW, Melton LB, Hays S, Levy MF, Klintmalm GB. Acute kidney injury following liver transplantation: definition and outcome. Liver Transpl. 2009 May;15(5):475-83. doi: 10.1002/lt.21682.

    PMID: 19399734RESULT

  • Fouad TR, Abdel-Razek WM, Burak KW, Bain VG, Lee SS. Prediction of cardiac complications after liver transplantation. Transplantation. 2009 Mar 15;87(5):763-70. doi: 10.1097/TP.0b013e318198d734.

    PMID: 19295324RESULT

  • Levesque E, Hoti E, Azoulay D, Honore I, Guignard B, Vibert E, Ichai P, Antoun F, Saliba F, Samuel D. Pulmonary complications after elective liver transplantation-incidence, risk factors, and outcome. Transplantation. 2012 Sep 15;94(5):532-8. doi: 10.1097/TP.0b013e31825c1d41.

    PMID: 22885879RESULT

  • Ramos E, Dalmau A, Sabate A, Lama C, Llado L, Figueras J, Jaurrieta E. Intraoperative red blood cell transfusion in liver transplantation: influence on patient outcome, prediction of requirements, and measures to reduce them. Liver Transpl. 2003 Dec;9(12):1320-7. doi: 10.1016/jlts.2003.50204.

    PMID: 14625833RESULT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

April 21, 2016

First Posted

May 4, 2016

Study Start

January 1, 2011

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)