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

Cardiac Surgery Clinical Trial

— POAM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06287619
• Other study ID #: 22-5685
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: Keyvan Karkouti, MD
• Phone: 416-340-4800
• Email: Keyvan.Karkouti[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Cardiac Surgery
• Deficiency Diseases

Intervention

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:
• 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).

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto General Hospital - University Health Network	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	Heart and Stroke Foundation of Canada, Queen's University, Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Feasibility Outcome 2: Adequate patient enrollment	Adequate patient enrollment defined as =20% of eligible patients enrolled.	through study completion, an average of 1 year.
Primary	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.