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

Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery: A Pilot, Multi-centre, Placebo-controlled Randomized Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Surgery; Chronic Iron Deficiency Anaemia
• Intervention / Treatment: Drug: Monoferric Injectable Product; Other: 0.9% sodium chloride solution

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Keyvan Karkouti, MD; Phone Number: 8597 416-340-4800; Email: Keyvan.Karkouti@uhn.ca
• Study Contact Backup: Name: Deep Grewal; Phone Number: 4221 416-340-4800; Email: Deep.Grewal@uhn.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 3N6
      • Kingston Health Sciences Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital - University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients who are undergoing any non-emergency cardiac surgery with cardiopulmonary bypass (CPB) and who meet all following criteria:

1. Age greater than 18 years old

2. Preoperative iron-deficiency anemia, defined as Hb <130 g/L with any one of:

   1. ferritin < 30 μg/L; or
   2. ferritin 30-100 μg/L and transferrin saturation <20%; or
   3. reticulocyte Hb content < 29 pg, where available

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for the study:

1. specialized procedures (e.g., ventricular assist device insertion, thoracoabdominal aneurysm, complex adult congenital surgery and heart transplant)

2. established contraindications to IV iron:

   1. hypersensitivity to the iron product
   2. history of >2 food and/or drug allergic reactions (excluding drug intolerance)
   3. non-iron deficiency anemias such as myelodysplastic syndrome
   4. history of iron overload or disturbances in use of iron such as hemochromatosis or hemosiderosis
   5. decompensated liver cirrhosis (MELD ≥ 19) or active hepatitis
   6. active infection
3. 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)
4. refusal of blood products for religious or other reasons
5. known pregnancy
6. already enrolled in this trial
7. enrolment in another interventional trial which may impact anemia or transfusion management (for example, a trial of hemostatic therapies, such as tranexamic acid)
8. receipt of intravenous iron at any point in the 6 weeks prior to randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; Ferric derisomaltose will be prepared by an unblinded research pharmacist 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.; Other Names: Ferric derisomaltose
Placebo Comparator: Control group; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Sunnybrook Health Sciences Centre; Queen's University; Heart and Stroke Foundation of Canada
• Investigators: Principal Investigator: Justyna Bartoszko, MD, University Health Network, Toronto; Principal Investigator: Jeannie Callum, MD, Queen's University; Principal Investigator: Yulia Lin, MD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Intravenous Iron; Ferric derisomaltose (Monoferric)
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases; Iron Deficiencies
• Other Study ID Numbers: 22-5685

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No