drugset / Trial / NCT02031289
Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.
RandomizedParallel-groupQuadruple-blindTreatment
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
Timeline
- Start
- 2013-12
- Primary completion
- 2017-12
- Completion
- 2018-05
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Erythropoietin alpha | Protein / enzyme biologic | 40000 iu | Subcutaneous |
| Comparator | Ferric carboxymaltose | Other / unclassified | 1000 mg | Intravenous |
| Comparator | Vitamin B12 | Other / unclassified | 1 mg | Subcutaneous |
| Comparator | folic acid | Other / unclassified | 5 mg | Oral |