INTRAVENOUS IRON TO TREAT POSTOPERATIVE ANEMIA IN OLDER CARDIAC SURGERY PATIENTS: A RANDOMIZED CONTROLLED TRIAL

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.

This study has been transitioned to CTIS with ID 2024-515920-35-01 check the CTIS register for the current data.

To determine the effect of treatment of postoperative iron deficiency anemia
(IDA) with intravenous iron (IVI) on disability 90 days after cardiac surgery.

Randomized placebo-controlled double blind multicenter trial.

Postoperative treatment with a single dose IVI (ferric derisomaltose, Monofer®,
N = 155) compared to postoperative treatment with sodium chloride 0.9%
(placebo, N = 155).

Study related benefits:
Anemia after cardiac surgery is very common and causes fatigue and lethargy,
which impairs recovery. Treatment of anemia with oral iron tablets takes
several months to increase RBC counts and is often not well tolerated due to
side effects, such as stomach pain and constipation. IVI has minimal side
effects and treatment consists of a single gift (which takes approximately 60
minutes). IVI has a proven positive effect on Hb values in the postoperative
trajectory, and so it is our expectation that patients who receive IVI will
have a faster recovery and experience less postoperative disability.

Study related risks: Ferric derisomaltose is an IV therapy approved by the
European Medicines Agency (EMA) for treatment of iron deficiency where oral
iron cannot be used or there is a need for rapid delivery of iron. Ferric
derisomaltose was originally approved in the European Union (EU) in 2009, and
it has been available in the Netherlands since 2009 with the trade name
Monofer. All IVI preparations carry a small risk for acute severe
hypersensitivity reactions. Other less severe manifestations of immediate
hypersensitivity, such as urticaria and itching may also occur. In a review of
the safety of IV iron preparations that included ferric derisomaltose, the EMA
concluded that the benefit-risk balance of intravenous iron containing
medicinal products is favorable as the benefits outweigh the risks in the
treatment of iron deficiency when used under their current indications. Ferric
derisomaltose will be used within its approved indication in the study, and
subsequently the risks associated with the treatment are considered low.
Furthermore, for this study an additional blood sample is required. Risks of
venepuncture are minimal and limited to blood loss, fainting, infection and
multiple attempts to locate a vein.

Extent of the burden
Control group: standard preoperative care, additional assessment of
questionnaires for disability (12-item WHODAS 2.0), HRQL (TOPICS-SF) and
cardiac symptoms (RDS), standard ICU admission after cardiac surgery, screening
for postoperative IDA on POD1 (i.e. assessment of iron status), intravenous
treatment with placebo on POD1 in the ICU (total duration of administration and
monitoring approximately 90 minutes. Note: this will not prolong routine ICU
admission), standard hospital follow-up for complications, venepuncture for
study related blood sample at hospital discharge, additional follow-up with
questionnaires for disability (12-item WHODAS 2.0), HRQL (TOPICS-SF) and
cardiac symptoms (RDS) at POD 90. At 90 days, the results from the functional
tests (e.g. steep ramp test or 6-minute walk test) that are routinely performed
during standardized cardiac rehabilitation programs in both hospitals are
requested through the treating physical therapist. Furthermore, laboratory
results (i.e. Hb values) will be requested (if available) from treating
cardiologists when patients have visited the out-patient clinic for follow-up.
Intervention group: standard preoperative care, additional assessment of
questionnaires for disability (12-item WHODAS 2.0), HRQL (TOPICS-SF) and
cardiac symptoms (RDS), standard ICU admission after cardiac surgery, screening
for postoperative IDA on POD1 (i.e. assessment of iron status), intravenous
treatment with IVI (ferric derisomaltose) on POD1 in the ICU (total duration
of administration and monitoring approximately 90 minutes. Note: this will not
prolong routine ICU admission), standard hospital follow-up for complications,
venepuncture for study related blood sample at hospital discharge, additional
follow-up with questionnaires for disability (12-item WHODAS 2.0), HRQL
(TOPICS-SF) and cardiacsymptoms (RDS) at POD 90. At 90 days, the results from
the functional tests (e.g. steep ramp test or 6-minute walk test) that are
routinely performed during standardized cardiac rehabilitation programs in both
hospitals are requested through the treating physical therapist. Furthermore,
laboratory results (i.e. Hb values) will be requested (if available) from
treating cardiologists when patients have visited the out-patient clinic for
follow-up