Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients
ConditionIron Deficiency Anemia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age70+
Sponsordr. P. Noordzij
About this 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. 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 criteria
This trial does not accept healthy volunteersQualifiers
Mentally competent with age ≥ 70 years
Elective AVR or CABG surgery
No inotropic agents or ventilation at time of final inclusion (POD 1)
Expected discharge to general ward at POD 1
Disqualifiers
Medical history of iron overload/haemochromatosis
Medical history of liver cirrhosis or ALT/AST value in blood serum triple of normal value (female patients: ALT >120, AST >105 U/L. Male patients: ALT>150, AST>135 U/L)
Severe renal failure (eGFR<15ml/min/1.73m2)
Recent treatment with IVI (<12 weeks prior)
Trial design
Design model
Parallel
Treatments tested in this trial
Ferric Derisomaltose 100 MG/ML
DrugPostoperative treatment with a single dose IVI (ferric derisomaltose), with a dose of 20mg/kg in approximately 60 minutes.
Sodium chloride
DrugPostoperative treatment with a single dose NaCl 0.9% in approximately 60 minutes.
Treatment groups
310 Participants
are divided into 2 treatment groupsGroup A: Intravenous iron (ferric derisomaltose)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Disability
Disability measured by the 12- item World Health Organization Disability Assessment score 2.0 (WHODAS-12). Based on the answers a disability score can be calculated. 0% is no disability and 100% is fully disabled.
Time frame
90 days after elective cardiac surgerySecondary outcomes
1
Change in patient reported outcome measures (PROMs) related to dyspnea
PROMS related to dyspnea are assessed with the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale scores range from 0 to 4 with higher scores indicating more dyspnea with common activities.
Time frame
90 days after elective cardiac surgery2
Change in patient reported outcome measures (PROMs) related to health related quality of life (HRQL)
HRQL is assessed with The Older Persons and Informal Caregivers-Short Form (TOPICS-SF) questionnaire. The TOPIC-SF is comprised of 22 items in 7 domains of health and well-being. Scores in the different domains ranges from 0 to 5, higher scores indicating diminished quality of life.
Time frame
90 days after elective cardiac surgery3
Red blood cell transfusions
Number of red blood cell transfusions during hospital stay
Time frame
+/- 7 days after elective cardiac surgery4
Change in reticulocyte hemoglobin content
Change in reticulocyte hemoglobin content from randomization to hospital discharge
Time frame
+/- 7 days after elective cardiac surgeryOther outcomes
1
Functional outcome (exploratory endpoint)
As part of routine care, patients are offered a cardiac revalidation program supervised by a physical therapist after hospital discharge (POD 90). To assess whether patients can safely start exercising, a functional test is performed (e.g. steep ramp or 6-minute walk test). For this study, the results of these tests will be requested to assess functional capacity after surgery
Time frame
+/- 90 days after elective cardiac surgery2
Change in Hb level at 90 days (exploratory endpoint)
Laboratory results (i.e. Hb values if available) assessed by the treating cardiologist are requested when patients have visited the hospital during follow-up
Time frame
+/- 90 days after elective cardiac surgerySponsors and contacts
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Source ClinicalTrials.gov