Clinical trial NCT06287619: Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery
Official title: Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery: A Pilot, Multi-centre, Placebo-controlled Randomized Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Iron Deficiency Anaemia
Cardiac Surgery
Keywords: Ferric derisomaltose (Monoferric)
Intravenous Iron
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Kingston Health Sciences Centre
name: Sunnybrook Health Sciences Centre
name: Heart and Stroke Foundation of Canada
First posted: 2024-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 ≤ 300 μg/L and transferrin saturation ≤ 20%; or
   2. 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

Primary outcomes:
measure: Feasibility Outcome 1: Percentage of major protocol deviations
timeFrame: through study completion, an average of 1 year.
measure: Feasibility Outcome 2: Adequate patient enrollment
timeFrame: through study completion, an average of 1 year.
measure: Feasibility Outcome 3: Percentage of patients lost to follow-up at 90 days
timeFrame: through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital - University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Justyna Bartoszko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kingston Health Sciences Centre
name: Jeannie Callum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Yulia Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: