drugset / Trial / NCT06287619
Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery
Phase 2
Recruiting
60 enrolled
University Health Network, Toronto
Heart and Stroke Foundation of Canada · collabKingston Health Sciences Centre · collabSunnybrook Health Sciences Centre · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-04-03
- Primary completion
- 2026-12
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferric Derisomaltose | Unknown | 1000 mg | Intravenous |