Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05835882
Status:
RECRUITING
Last Update Posted:
2023-09-05
First Post:
2023-04-19
Brief Title:
Blood Salvage From Liver Donors a Feasibility Pilot Study
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Blood Salvage From Liver Donors a Feasibility Pilot Study BLEED Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
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:
BLEED
Brief Summary:
Blood recovery is a common procedure that limits patient exposure to allogeneic blood products Blood recovery is usually performed during different types of surgery including cardiac and vascular surgery or liver transplantation Basically the process utilizes blood cell savers and cell separators and is finalized to auto-transfusion In our hospital the blood recovery is carried out with the CATSmart continuous-flow device Fresenius Kabi AG Bad Homburg Germany that warrants the removal of 95 of heparin potassium free hemoglobin and non-emulsifiable lipids In liver transplantation LT before removing the organ from the donor the blood is usually flushed out of the liver Nonetheless in some circumstances donor blood cells may be transferred to recipients together with the solid organ during graft implantation This is a feasibility study exploring RBC red blood cell concentrates obtained from the blood organ donor to support transfusion requirements in liver recipients Donor RBC units are produced according to the quality standards recommended by the European Directorate for the Quality of Medicines HealthCare of the Council of Europe with equivalent content of Hb and residual leukocytes as standard RBC products
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None