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Intravenous Iron for Iron-Deficiency Anemia (POAM Trial)

Phase 2

Waitlist Available

Led By Justyna Bartoszko, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year.

Summary

This trial is being conducted at three cardiac surgery centers in Canada to see if giving intravenous iron therapy to patients with chronic iron-deficiency anemia after cardiac surgery can improve their outcomes compared to a placebo

Who is the study for?

This trial is for patients with chronic iron-deficiency anemia who are undergoing cardiac surgery. They should be at one of the three participating Canadian centers. The study excludes those who don't meet the specific health criteria set by the researchers, but these aren't detailed here.

What is being tested?

The POAM trial is testing if giving IV iron therapy after cardiac surgery can help patients recover better compared to a saltwater placebo. It's done in two groups: one gets iron and the other gets placebo, chosen randomly.

What are the potential side effects?

Possible side effects of IV iron include allergic reactions, infections at injection site, headaches, dizziness or high blood pressure. The saltwater placebo generally has fewer risks but may cause vein irritation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility Outcome 1: Percentage of major protocol deviations

Feasibility Outcome 2: Adequate patient enrollment

Feasibility Outcome 3: Percentage of patients lost to follow-up at 90 days

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention GroupExperimental Treatment1 Intervention

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.

Group II: Control groupPlacebo Group1 Intervention

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.

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