Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 3:55 PM
Study NCT ID:
NCT01211366
Status:
COMPLETED
Last Update Posted:
2012-02-13
First Post:
2010-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Cell Salvage Post-operatively in Infants to Decrease Use of Allogeneic Blood Product Transfusions
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
Post-operative Infusion of Intra-operative Cell Salvage Reduces Allogeneic Blood Product Transfusions and Volume Resuscitation in Pediatric Cardiac Surgery and Improves Clinical Outcomes
Status:
COMPLETED
Status Verified Date:
2012-02
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:
cell salvage
Brief Summary:
Transfusion of washed intra-operative cell salvage post-operatively in the PCICU can be performed safely without increased risk of bleeding or release of inflammatory mediators. This will reduce the need for allogeneic blood products as well as crystalloid and colloid infusions and thus decrease the length of ventilation and intensive care duration for these infants.
Detailed Description:
None
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?: