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

Phase 2

Not yet recruiting

• Conditions: Chronic Iron Deficiency Anaemia; Cardiac Surgery
• Interventions: Drug: Monoferric Injectable Product; Other: 0.9% sodium chloride solution

• Registration Number: NCT06287619
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-03-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29
• Study Start: 2024-09
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Monoferric Injectable Product	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.
Control group	0.9% sodium chloride solution	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.

Primary Outcome Measures

Name	Time	Method
Feasibility Outcome 2: Adequate patient enrollment	through study completion, an average of 1 year.	Adequate patient enrollment defined as ≥20% of eligible patients enrolled.
Feasibility Outcome 3: Percentage of patients lost to follow-up at 90 days	through study completion, an average of 1 year.	Percentage of patients lost to follow-up at 90 days with a feasibility threshold of ≤ 5%.
Feasibility Outcome 1: Percentage of major protocol deviations	through study completion, an average of 1 year.	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)

Trial Locations

Locations (3)

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada

Toronto General Hospital - University Health Network; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada