Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients: a Randomized Controlled Trial'

Who is this study for? Patients undergoing elective AVR or CABG surgery
What treatments are being studied? Ferric Derisomaltose
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Postoperative anemia is common in cardiac surgery with cardiopulmonary bypass. Iron deficiency delays the recovery from postoperative anemia and may negatively affect the postoperative trajectory of cardiac surgery patients. The objective of the study is to determine the effect of treatment of postoperative iron deficiency anemia with intravenous iron on disability 90 days after surgery. This will be evaluated in a randomized placebo-controlled double blind two-center trial in which 310 elective cardiac surgery patients will be included.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• Mentally competent with age ≥ 70 years

• Elective AVR or CABG surgery

• Expected uncomplicated postoperative trajectory, defined as:

• No inotropic agents or ventilation at time of final inclusion (POD 1)

• Expected discharge to general ward at POD 1

• Moderate postoperative IDA, defined as:

• Hb between 85 and 110 g/L and

• Ferritin \<100 µg/L or

• Iron saturation (TSAT) \< 20%

Locations
Other Locations
Netherlands
Amphia Hospital
RECRUITING
Breda
St Antonius Hospital
RECRUITING
Nieuwegein
Contact Information
Primary
Peter Noordzij, MD, PhD
p.noordzij@antoniusziekenhuis.nl
883203000
Backup
Rosa Smoor, MD
r.smoor@antoniusziekenhuis.nl
883203000
Time Frame
Start Date: 2021-09-23
Estimated Completion Date: 2025-12
Participants
Target number of participants: 310
Treatments
Experimental: Intravenous iron (ferric derisomaltose)
The intervention consists of a single dose of ferric derisomaltose (Monofer®) 100 mg/mL solution for infusion (Monofer® is a registered product with a marketing authorization in the Netherlands (RVG number: 103070). Manufacturer: Pharmacosmos A/S, Denmark. Dutch marketing authorization holder: Cablon Medical B.V). The method of administration and dosage of the investigational medication are standard treatment. The ferric derisomaltose dose will calculated for each patient depending on body weight (20mg/kg) and diluted in 250 ml NaCl 0.9%. Treatment takes approximately 60 minutes. Vital signs of the patient will be monitored during administration of the investigational medication and for 30 minutes afterwards
Placebo_comparator: Placebo
Single dose of sodium chloride 0.9% (250ml). Treatment takes approximately 60 minutes. Vital signs of the patient will be monitored during administration of the investigational medication and for 30 minutes afterwards
Authors
Rosa Smoor
Related Therapeutic Areas
Sponsors
Leads: dr. P. Noordzij
Collaborators: Pharmacosmos A/S

This content was sourced from clinicaltrials.gov