ltrarapid iron polymaltose infusion for treatment of iron deficiency anaemia in a general hospital population at a single centre safety study

Phase 4

Completed

• Conditions: Iron deficiency; Iron deficiency anaemia; Anaemia of chronic kidney disease; Anaemia of chronic heart failure; Blood - Anaemia; Cardiovascular - Other cardiovascular diseases; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12619000272190
• Lead Sponsor: Iouri Banakh

Brief Summary

ltrarapid iron polymaltose infusions have similar safety to 1 hour and 4 hours infusions, and that of ferric carboxymaltose. The delayed reaction rate was 12..5% with mostly mild side effects reported by study participants. Over 95% of participants indicated that they would have iron polymaltose infusions at the ultrarapid rates again if offered for their treatment.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Study Completion: 2021-08-12
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Frankston Hospital patients diagnosed with iron deficiency anaemia of any cause requiring replacement with iron polymaltose doses of up to 1500 mg.
Treating team provided consent for their patient to be approached to participate.
Patients able to provide informed consent.

Exclusion Criteria

Patients requiring doses greater than 1500 mg of iron polymaltose.
Patients unable to give informed consent.
Patients unable to read English.
Treating team declining for their patient to be approached to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the overall adverse event rate during the iron polymaltose infusions. Nursing staff will assess for any adverse events and these will be classified as mild reactions which are defined as those that do not require a change in the infusion rate, treatment or prolongation of hospital stay; moderate reactions are defined as those that require an interruption or change to infusion rate, minor treatment such as analgesia or additional monitoring; and severe reactions are defined as those that require the iron infusion to be stopped without intention to restart and where patients require urgent medical attention with administration of resuscitation or severe allergic reaction medications such as adrenaline, hydrocortisone or parenteral antihistamine, or prolongation of hospitalisation (more than 1 day). Examples of reactions include arm pain, chest pain, anaphylaxis, palpitations or unusual sensation in arms.[Adverse events occurring during the 15 minute infusions.]

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes include the adverse event rate during the week post-infusion as well as severity of adverse events, graded as mild, moderate or severe. During the week post infusion, adverse events will be graded as: mild for those not requiring treatment; moderate where minor treatment was required; and severe for those requiring attention of a local doctor or hospital presentation. These will be obtained by directly contacting patients via phone on week after the infusion for selfreporting of any reactions. Examples of reactions include: headache, arthralgia, myalgia, fatigue, dizziness and nausea.[Within 1 week of the iron infusion.]