Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450398
Status:
UNKNOWN
Last Update Posted:
2008-01-29
First Post:
2007-03-20
Brief Title:
YSPSL for Prevention of Delayed Graft Function in Cadaveric Liver Transplantation
Sponsor:
Ys Therapeutics Inc
Organization:
Ys Therapeutics Inc
Study Overview
Official Title:
A Controlled Prospective Blinded Randomized Single-Center Study of YSPSL for Prevention of Ischemic Reperfusion Injury in Patients Undergoing Cadaveric Orthotopic Liver Transplantation
Status:
UNKNOWN
Status Verified Date:
2008-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is designed to assess the feasibility of evaluating YSPSL for the amelioration of ischemia reperfusion injury following liver transplantation by administering YSPSL into the liver graft directly ex vivo via the portal vein and to the recipient intravenously prior to reperfusion Recently P-selectin expression has been associated in liver grafts with prolonged cold storage times and rejection By examining biomarkers of IRI including P-selectin by immunohistochemistry andor quantitative PCR liver histology and hepatic blood flow using established techniques the goal of this study is to evaluate the feasibility of using these modalities for future studies of safety and efficacy
Detailed Description:
This will be a single-center single-dose study The study will be a randomized double-blind placebo-controlled single-dose study Patients who are undergoing cadaveric orthotopic liver transplantation and are at risk for development of DGF based upon known risk factors will be eligible to participate in the study 12 patients will be enrolled in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None