Chronic Iron Deficiency AnaemiaPhase 2POAMNCT06287619
Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery
A Phase 2 study testing Monoferric Injectable Product and 0.9% sodium chloride solution in people with Chronic Iron Deficiency Anaemia and Cardiac Surgery, run by University Health Network, Toronto at 3 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Iron Deficiency Anaemia, Cardiac Surgery
- What is being tested?
- Monoferric Injectable Product and 0.9% sodium chloride solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesCanada
- Study dates
- 3 Apr 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are undergoing any non-emergency open cardiac surgery and who meet all following criteria:
- Age greater than 18 years old
- Preoperative iron-deficiency with or without anemia (defined as Hb <130 g/L) with any one of:
- ferritin ≤100 μg/l; or
- ferritin ≤ 300 μg/L and transferrin saturation ≤ 20%; or
- reticulocyte Hb content < 29 pg, where available
Who cannot join
- Patients who meet any of the following criteria are not eligible for the study:
- specialized procedures (e.g., ventricular assist device insertion, thoracoabdominal aneurysm, complex adult congenital surgery and heart transplant)
- established contraindications to IV iron:
- hypersensitivity to the iron product
- history of >2 food and/or drug allergic reactions (excluding drug intolerance)
- non-iron deficiency anemias such as myelodysplastic syndrome
Show all 15Show fewer
- history of iron overload or disturbances in use of iron such as hemochromatosis or hemosiderosis
- decompensated liver cirrhosis (MELD ≥ 19) or active hepatitis
- active infection
- 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)
- refusal of blood products for religious or other reasons
- known pregnancy
- already enrolled in this trial
- enrolment in another interventional trial which may impact anemia or transfusion management (for example, a trial of hemostatic therapies, such as tranexamic acid)
- receipt of intravenous iron at any point in the 6 weeks prior to randomization
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 3N6
Jeannie Callum, MD BA FRCPC, 613-533-6000 ext. 74897, Jeannie.Callum@kingstonhsc.ca
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Yulia Lin, MD FRCPC, (416) 480-4042, Yulia.Lin@sunnybrook.ca
- Recruiting
Toronto General Hospital - University Health Network
Toronto, Ontario, M5G 2C4
Justyna Bartoszko, MD MSc FRCPC, 416-340-4800 ext. 3243, justyna.bartoszko@uhn.ca
About this study
Official title: 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.
- Conditions
- Chronic Iron Deficiency Anaemia, Cardiac Surgery
- Being tested
- Monoferric Injectable Product, 0.9% sodium chloride solution
- Keywords
- Ferric derisomaltose (Monoferric), Intravenous Iron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monoferric Injectable ProductDrug
Also called Ferric derisomaltose
Ferric derisomaltose will be prepared by an unblinded research pharmacist/delegated staff 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.
0.9% sodium chloride solutionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Drug: Monoferric Injectable Product |
| Control group | Placebo comparator | 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. Receives: Other: 0.9% sodium chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 1 year.
Feasibility Outcome 2: Adequate patient enrollment
Adequate patient enrollment defined as ≥20% of eligible patients enrolled.
Measured: 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%.
Measured: through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start3 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Iron Deficiency AnaemiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Sunnybrook Health Sciences Centre, Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Justyna Bartoszko, MD, Principal investigator, University Health Network, TorontoJeannie Callum, MD, Principal investigator, Kingston Health Sciences CentreYulia Lin, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287619
- Sponsor's protocol ID
- 22-5685
- Acronym
- POAM
- Status last verified
- Jun 2025
- First submitted
- 23 Feb 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bartoszko J, Miles S, Ansari S, Grewal D, Li M, Callum J, McCluskey SA, Lin Y, Karkouti K. Postoperative intravenous iron to treat iron-deficiency anaemia in patients undergoing cardiac surgery: a protocol for a pilot, multicentre, placebo-controlled randomized trial (the POAM trial). BJA Open. 2024 Jul 27;11:100303. doi: 10.1016/j.bjao.2024.100303. eCollection 2024 Sep.
PubMed 39161801
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery: A Pilot, Multi-centre, Placebo-controlled Randomized Trial.
- ClinicalTrials.gov ID
- NCT06287619
- Acronym / sponsor ID
- POAM / 22-5685
- Conditions
- Chronic Iron Deficiency Anaemia, Cardiac Surgery
- Keywords
- Ferric derisomaltose (Monoferric), Intravenous Iron
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Sunnybrook Health Sciences Centre, Heart and Stroke Foundation of Canada
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Monoferric Injectable ProductPatients 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 | Placebo comparator | Other: 0.9% sodium chloride solutionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are undergoing any non-emergency open cardiac surgery and who meet all following criteria:
- Age greater than 18 years old
- Preoperative iron-deficiency with or without anemia (defined as Hb <130 g/L) with any one of:
Key exclusion criteria (15 listed)
- specialized procedures (e.g., ventricular assist device insertion, thoracoabdominal aneurysm, complex adult congenital surgery and heart transplant)
- established contraindications to IV iron:
- 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)
- refusal of blood products for religious or other reasons
- known pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monoferric Injectable ProductAlso: Ferric derisomaltoseFerric derisomaltose will be prepared by an unblinded research pharmacist/delegated staff 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. | Drug | Intervention Group |
| 0.9% sodium chloride solutionPatients 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). | Other | Control group |
Primary outcome
Feasibility Outcome 1: Percentage of major protocol deviations
Time frame: 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)
Feasibility Outcome 2: Adequate patient enrollment
Time frame: 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
Time frame: through study completion, an average of 1 year.
Percentage of patients lost to follow-up at 90 days with a feasibility threshold of ≤ 5%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Derived from this study: PubMed 39161801Bartoszko J, Miles S, Ansari S, Grewal D, Li M, Callum J, McCluskey SA, Lin Y, Karkouti K. Postoperative intravenous iron to treat iron-deficiency anaemia in patients undergoing cardiac surgery: a protocol for a pilot, multicentre, placebo-controlled randomized trial (the POAM trial). BJA Open. 2024 Jul 27;11:100303. doi: 10.1016/j.bjao.2024.100303. eCollection 2024 Sep.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justyna Bartoszko, MD principal investigator
University Health Network, Toronto
Jeannie Callum, MD principal investigator
Kingston Health Sciences Centre
Yulia Lin, MD principal investigator
Sunnybrook Health Sciences Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Monoferric Injectable Product and 0.9% sodium chloride solution in people with Chronic Iron Deficiency Anaemia and Cardiac Surgery, run by University Health Network, Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keyvan Karkouti, MD (416-340-4800 ext. 8597, Keyvan.Karkouti@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Outcome 1: Percentage of major protocol deviations (time frame: through study completion, an average of 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06287619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.