protocolSection identificationModule nctId: NCT06287619, orgStudyIdInfo id: 22-5685, briefTitle: Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery, acronym: POAM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, collaborators name: Queen's University, collaborators name: Sunnybrook Health Sciences Centre, collaborators name: Heart and Stroke Foundation of Canada, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Iron Deficiency Anaemia, conditions: Cardiac Surgery, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: This is a blinded study, with patients randomized to receive ferric derisomaltose (Monoferric) or placebo. Given that the products have different physical appearances, an unblinded research pharmacist will prepare the IMP then blind the appearance of the IMP for both the intervention group and control group by covering the IV bag and tubing with opaque plastic. All other clinicians, research coordinators, outcome assessors, and patients will remain blinded by using a generic product label in the patient chart and/or the electronic product name (i.e., POAM study drug dose 1 and dose 2, rather than specifying type of product used)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Monoferric Injectable Product, interventions name: 0.9% sodium chloride solution, outcomesModule primaryOutcomes measure: Feasibility Outcome 1: Percentage of major protocol deviations, primaryOutcomes measure: Feasibility Outcome 2: Adequate patient enrollment, primaryOutcomes measure: Feasibility Outcome 3: Percentage of patients lost to follow-up at 90 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kingston Health Sciences Centre, city: Kingston, state: Ontario, zip: K7L 3N6, country: Canada, geoPoint lat: 44.22976, lon: -76.48101, locations facility: Sunnybrook Health Sciences Centre, city: Toronto, state: Ontario, zip: M4N 3M5, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Toronto General Hospital - University Health Network, city: Toronto, state: Ontario, zip: M5G 2C4, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False