Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287619
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-23
Brief Title:
Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery A Pilot Multi-centre Placebo-controlled Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
POAM
Brief Summary:
POAM is a multicenter randomized controlled internal pilot trial using a conventional parallel group two-armed design at 3 cardiac surgery centres in Canada The study is designed to assess the feasibility of a future definitive RCT investigating whether in patients with chronic iron-deficiency anemia undergoing cardiac surgery IV iron therapy in the postoperative period initiated shortly after surgery and repeated at 42 days after surgery if needed improves clinical outcomes days alive and out of hospital at 90 days after surgery DAOH-90 relative to placebo
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