Ferric Carboxymaltose for Anemia

Inclusion criteria

• {"criterion_text":"- Provision of written informed consent"}
• {"criterion_text":"- Male and female participants"}
• {"criterion_text":"- Weight > 50 kg"}
• {"criterion_text":"- > 18 years of age"}
• {"criterion_text":"- Scheduled for complex aortic surgery, liver resection or pancreatic resection"}

Exclusion criteria

• {"criterion_text":"- Short expected survival (less than six months)"}
• {"criterion_text":"- Unsuitable for inclusion according to the investigator"}
• {"criterion_text":"- Pregnancy or breastfeeding"}
• {"criterion_text":"- Intra-venous iron therapy within one month prior to surgery"}
• {"criterion_text":"- Severe anaemia (B-Hb <80 mg/L) prior to surgery"}
• {"criterion_text":"- Contraindication to Ferric Carboxymaltose according to SmPC"}
• {"criterion_text":"- Iron overloading disorder, i.e. hemochromatosis"}
• {"criterion_text":"- Risk of small for size future liver remnant"}
• {"criterion_text":"- Pre-operative renal replacement therapy"}
• {"criterion_text":"- Enrolled in another drug or medical device study within 30 days prior to enrolment of the current study"}
• {"criterion_text":"- Another planned major surgical procedure before the five week follow up"}

Primary endpoints

• {"endpoint_text":"- To examine if 1000 mg iv Ferric Carboxymaltose administered immediately following hepatic or pancreatic resection or complex aortic surgery with 400 – 4000 ml perioperative blood loss affect a composite of death, number of red blood cells transfusions, post-operative severe anaemia (Hb < 80 g/L) and change in FACT-An QoL compared to pre-operative baseline at five weeks after surgery. The composite endpoint is assessed by win ratio in the order given above.","definition_or_measurement_approach":"Composite of (in order): death, number of red blood cells transfusions, post-operative severe anaemia (Hb < 80 g/L), and change in FACT-An QoL compared to pre-operative baseline at five weeks after surgery; assessed by win ratio in the order given."}

Secondary endpoints

• {"endpoint_text":"- If the intervention affects levels of post operative Hb, and if this is linked to the primary outcome and affects early post operative recovery and performance status five weeks after surgery.","definition_or_measurement_approach":"Post-operative haemoglobin (Hb) levels and linkage to primary outcome; assessed at five weeks after surgery."}
• {"endpoint_text":"- If the intervention affects complication rate after surgery, re-admissions to hospital after discharge and re-interventions after primary surgery. Analysed 1 year after surgery.","definition_or_measurement_approach":"Complication rates, re-admissions and re-interventions assessed at 1 year after surgery."}
• {"endpoint_text":"- If the intervention affects chance of receiving systemic oncological therapy in case of malignant disease. Follow-up 1 year after surgery.","definition_or_measurement_approach":"Proportion receiving systemic oncological therapy in patients with malignant disease; follow-up at 1 year."}
• {"endpoint_text":"- If the intervention affects rate of spinal ischemia after complex aortic repair. Follow-up 1 year after surgery.","definition_or_measurement_approach":"Incidence of spinal ischemia after complex aortic repair; follow-up at 1 year."}
• {"endpoint_text":"- Effects of Ferric Carboxymaltose between 5 weeks to 5 years after surgery in different subgroups.","definition_or_measurement_approach":"Longitudinal assessment of effects between 5 weeks and 5 years post-surgery across predefined subgroups (Sex, Comorbidity, Type of surgery, Peri-operative blood loss, Pre-operative anaemia and iron deficiency)."}
• {"endpoint_text":"- Number of adverse events reported during administration of Ferric Carboxymaltose iv and during the 5-week follow-up after surgery.","definition_or_measurement_approach":"Safety: count of adverse events during administration and during 5-week post-operative follow-up."}
• {"endpoint_text":"- Morbidity, mortality and recurrence of oncological disease reported during the 5-year follow-up.","definition_or_measurement_approach":"Morbidity, mortality and cancer recurrence assessed over 5-year follow-up."}

Sweden

Earliest CTIS Part Ii Submission Date

19-12-2023

Latest Decision Or Authorization Date

13-03-2024

Processing Time Days

85

Number Of Sites

5

Number Of Participants

338

Primary sponsor

Full Name

Region Uppsala

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"","full_name":"Vifor Pharma","duties_or_roles":"Monetary support","organisation_type":""}