NCT00698399

Brief Summary

This is an observational study examining serum markers in patients who are undergoing either a cadaveric liver transplant or a living related liver transplant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

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

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2010

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

June 12, 2008

Last Update Submit

February 27, 2018

Conditions

Keywords

livertransplantTMAONGALcystatin-CIschemia Reperfusion InjuryLiver TransplantLTxallantion

Study Arms (2)

1

Live Donor

2

Cadaveric Donor

Eligibility Criteria

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

Subjects will be recruited from those on the list awaiting liver transplantation at Vanderbilt University Medical Center (VUMC). They will be recruited by the investigators prior to the time of their transplantation surgery

You may qualify if:

  • American Society of Anesthesiologists (ASA) Class I-V.
  • Patient is undergoing elective Liver Transplant Surgery.
  • Patient is an adult, 18 years old or older.

You may not qualify if:

  • Patients \< 18 Years of Age
  • Patients who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum of patients who are undergoing liver transplantation surgery

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeffrey M Waldman, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2008

First Posted

June 17, 2008

Study Start

March 1, 2008

Primary Completion

February 2, 2010

Study Completion

February 2, 2010

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations