Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery

NCT06287619 | Recruiting Phase 2 DMC

• 1 other identifier: 22-5685
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Iron Deficiency Anaemia; Cardiac Surgery

Keywords

Ferric derisomaltose (Monoferric); Intravenous Iron

Outcome Measures

Primary Outcomes (3)

• Feasibility Outcome 1: Percentage of major protocol deviations

  Percentage of major protocol deviations with a feasibility threshold of ≤ 5% (i.e., treatment not according to randomization allocation or dosing schedule; treatment initiated in ineligible patients or outside of allotted periods)

  through study completion, an average of 1 year.

• Feasibility Outcome 2: Adequate patient enrollment

  Adequate patient enrollment defined as ≥20% of eligible patients enrolled.

  through study completion, an average of 1 year.

• Feasibility Outcome 3: Percentage of patients lost to follow-up at 90 days

  Percentage of patients lost to follow-up at 90 days with a feasibility threshold of ≤ 5%.

  through study completion, an average of 1 year.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients randomized to the IV iron group will receive 1000 mg ferric derisomaltose (Monoferric) diluted in 100 mL of 0.9 % sodium chloride solution, via intravenous infusion over 1 hour using an opaque IV bag and tubing for blinding.

Drug: Monoferric Injectable Product

Control group

PLACEBO COMPARATOR

Patients randomized to the placebo group will receive 100 mL of 0.9 % sodium chloride solution via intravenous infusion using an opaque IV bag and tubing for blinding.

Other: 0.9% sodium chloride solution

Interventions

Monoferric Injectable Product DRUG

Ferric derisomaltose will be prepared by an unblinded research pharmacist/delegated staff as per standard of care procedures. Specifically, 10 mL (containing 1000 mg ferric derisomaltose) will be diluted in 100 mL of sterile 0.9% sodium chloride solution and drawn up into blinded syringes and tubing. The 1000 mg doses of ferric derisomaltose will be administered by a bedside nurse over 60 minutes via an infusion pump through a dedicated IV.

Also known as: Ferric derisomaltose

Intervention Group

0.9% sodium chloride solution OTHER

Patients in the control group will receive placebo, which will be 100 mL of sterile 0.9% sodium chloride solution and drawn up into blinded syringes and tubing according to good manufacturing practice (GMP).

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are undergoing any non-emergency open cardiac surgery and who meet all following criteria:
• Age greater than 18 years old
• Preoperative iron-deficiency with or without anemia (defined as Hb \<130 g/L) with any one of:
• ferritin ≤100 μg/l; or
• ferritin ≤ 300 μg/L and transferrin saturation ≤ 20%; or
• reticulocyte Hb content \< 29 pg, where available

You may not qualify if:

• Patients who meet any of the following criteria are not eligible for the study:
• specialized procedures (e.g., ventricular assist device insertion, thoracoabdominal aneurysm, complex adult congenital surgery and heart transplant)
• established contraindications to IV iron:
• hypersensitivity to the iron product
• history of \>2 food and/or drug allergic reactions (excluding drug intolerance)
• non-iron deficiency anemias such as myelodysplastic syndrome
• history of iron overload or disturbances in use of iron such as hemochromatosis or hemosiderosis
• decompensated liver cirrhosis (MELD ≥ 19) or active hepatitis
• active infection
• preoperative unstable hemodynamics defined as the requirement for vasopressors or inotropes, or active bleeding (as noted in the clinical record and/or defined as a requirement for red blood cell transfusion for ongoing clinical bleeding)
• refusal of blood products for religious or other reasons
• known pregnancy
• already enrolled in this trial
• enrolment in another interventional trial which may impact anemia or transfusion management (for example, a trial of hemostatic therapies, such as tranexamic acid)
• receipt of intravenous iron at any point in the 6 weeks prior to randomization

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: collaborator
• Heart and Stroke Foundation of Canada: collaborator
• University Health Network, Toronto: lead
• Kingston Health Sciences Centre: collaborator

Study Sites (3)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 3N6, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Toronto General Hospital - University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Related Publications (1)

• Bartoszko J, Miles S, Ansari S, Grewal D, Li M, Callum J, McCluskey SA, Lin Y, Karkouti K. Postoperative intravenous iron to treat iron-deficiency anaemia in patients undergoing cardiac surgery: a protocol for a pilot, multicentre, placebo-controlled randomized trial (the POAM trial). BJA Open. 2024 Jul 27;11:100303. doi: 10.1016/j.bjao.2024.100303. eCollection 2024 Sep.

  PMID: 39161801 DERIVED

MeSH Terms

Interventions

ferric derisomaltose; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Justyna Bartoszko, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Jeannie Callum, MD

  Kingston Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Yulia Lin, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keyvan Karkouti, MD

CONTACT

416-340-4800; Keyvan.Karkouti@uhn.ca

Deep Grewal

CONTACT

416-340-4800; Deep.Grewal@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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/delegated staff 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada.

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: April 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2025-06

Locations

CA (3)