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

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Epoetin Alfa; Ferric Compounds; Folic Acid; Hydroxocobalamin; Iron; Vitamin B 12; Vitamin B Complex; Vitamins

Criteria

Inclusion criteria:

• 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

Exclusion criteria:

• 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