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

University Health Network, Toronto

Status and phase: Enrolling; Phase 2

Conditions: Cardiac Surgery; Chronic Iron Deficiency Anaemia

Treatments: Drug: Monoferric Injectable Product; Other: 0.9% sodium chloride solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06287619

22-5685

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 with or without anemia (defined as Hb <130 g/L) with any one of:

   1. ferritin ≤100 μg/l; or
   2. ferritin ≤ 300 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

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.

Treatment:

Drug: Monoferric Injectable Product

Control group

Placebo Comparator group

Description:

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.

Treatment:

Other: 0.9% sodium chloride solution