Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.

NCT02031289 | Completed Phase 4 DMC

• 1 other identifier: IFA2012/IDCS
• Study Type: interventional
• Target: 1,003
• Locations: 1 country
• Sites: 1

Brief Summary

We are performing the above prospective randomized trial in 1'000 patients undergoing cardiac surgery. The study will answer the question of whether preoperative treatment of anemia or iron deficiency indeed improves transfusion needs (primary outcome) and important clinical outcomes (secondary outcome) in a large group of cardiac surgical patients. The list of inclusion and exclusion criteria was deliberately chosen short so that this patient group largely reflects today's clinical practice .

• Trial with medical product

Conditions

Anemia; Iron Deficiency

Keywords

Anemia; Iron deficiency; Cardiac surgery; Perioperative Care

Outcome Measures

Primary Outcomes (1)

• Red blood cell (RBC) units transfused

  7 days

Secondary Outcomes (18)

• Percentage of patients without any RBC transfusions

  90 days

• Combined allogeneic transfusions (RBC, FFP( fresh frozen plasma), platelets)

  90 days

• Length of stay in the intensive care unit (ICU)

  90 days

• Duration of mechanical ventilation

  90 days

• Acute kidney failure

  7 days

Study Arms (3)

Anemia

ACTIVE COMPARATOR

Hb \< 120 g/L in women, Hb \< 130 g/L in men Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid

Drug: Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid

Iron deficiency

ACTIVE COMPARATOR

ferritin \< 100 µg/l Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid

Drug: Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid

Natural comparison group

NO INTERVENTION

Patients without anemia or iron deficiency will be observed and the same postoperative measurements performed

Interventions

Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid DRUG

Treatment ) will be given the day before the operation (day -1) or a maximum of 2 days prior to the operation (day -2) in iron deficiency patients and a maximum of 3 days prior to the operation in anemic patients (day -3). Erythropoietin alpha (Eprex, Janssen-Cilag AG, Baar) 40'000 U sc. Ferric carboxymaltose (Ferinject, Vifor (International) AG, St. Gallen) 1000 mg in 100 ml NaCl over 30 min. Vitamin B12 (Vitarubin®-superconc., Streuli Pharma AG, Uznach) 1 mg sc. Folic acid (Acidum folicum, Streuli Pharma AG, Uznach) 5 mg po.

Also known as: Eprex, Ferinject, Vitarubin®-superconc, Acidum folicum

Anemia; Iron deficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing valve- and/or coronary bypass surgery
• Signed patient informed consent
• Only patients will be enrolled who won't have an emergency surgery on the same day

You may not qualify if:

• Participation in another clinical trial within the last 4 weeks prior to enrollment
• Addiction or other disease that did not allow the patient to assess the nature, scope and possible consequences of the clinical tial
• Patients who do not sign the consent form or may not fully understand from inadequate knowledge of German.
• Patients who have not reached the age of legal majority
• Pregnant or lactating women
• Jehovah's Witnesses
• Patients with endocarditis
• Existing allergy or intolerance to ferric carboxymaltose or mannitol

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Institute of Anaesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

• Rossler J, Schoenrath F, Seifert B, Kaserer A, Spahn GH, Falk V, Spahn DR. Iron deficiency is associated with higher mortality in patients undergoing cardiac surgery: a prospective study. Br J Anaesth. 2020 Jan;124(1):25-34. doi: 10.1016/j.bja.2019.09.016. Epub 2019 Oct 24.

  PMID: 31668348 DERIVED

• Spahn DR, Schoenrath F, Spahn GH, Seifert B, Stein P, Theusinger OM, Kaserer A, Hegemann I, Hofmann A, Maisano F, Falk V. Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial. Lancet. 2019 Jun 1;393(10187):2201-2212. doi: 10.1016/S0140-6736(18)32555-8. Epub 2019 Apr 26.

  PMID: 31036337 DERIVED

MeSH Terms

Conditions

Anemia; Iron Deficiencies

Interventions

Erythropoietin; Epoetin Alfa; ferric carboxymaltose; Leucovorin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Officials

• Donat R Spahn, Prof MD

  University Hospital Zurich, Institute of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: January 9, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

CH (1)