Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-15 @ 3:03 AM
Study NCT ID:
NCT02652520
Status:
COMPLETED
Last Update Posted:
2018-03-19
First Post:
2015-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation (OXYOP)
Sponsor:
University Hospital, Brest
Organization:
Study Overview
Official Title:
Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation
Status:
COMPLETED
Status Verified Date:
2018-03
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:
None
Brief Summary:
Kidney transplantation is the treatment of choice for end stage renal diseases, increasing life expectancy and quality of life. Improvement in organ preservation is a critical issue in this context.
This is a safety study evaluating the use of an oxygen carrier HEMO2Life® as an additive in organ preservation solution in kidney transplantation.
This is a safety study evaluating the use of an oxygen carrier HEMO2Life® as an additive in organ preservation solution in kidney transplantation.
Detailed Description:
Security of the use of HEMO2Life® will be analyzed by collecting all events within the first 3 months in terms of :
1. HEMO2Life® adverse effects
2. graft safety
3. recipient safety (any adverse event) Accountability search will be achieved for each of these events.
1. HEMO2Life® adverse effects
2. graft safety
3. recipient safety (any adverse event) Accountability search will be achieved for each of these events.
Study Oversight
Has Oversight DMC:
True
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?: