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A Phase IV, Unicenter, Randomized, Double-Blind, Parallel-Group, Comparaty Study of Intravenous and Oral Iron vs Placebo in Patient Under Extracorporeal Circulation in Cardiovascular Surgery
Anaemia is a common postoperative problem of cardiovascular surgery after cardiopulmonary bypass (CPB). Because of this the need for hemoderived blood transfusions is high. The purpose of this study was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact of the iron on the transfusion rate in postoperative cardiovascular surgery under extracorporeal circulation.
Details
| Lead sponsor | Fundación Canaria Rafael Clavijo para la Investigación Biomédica |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 159 |
| Start date | 2007-05 |
| Completion | 2009-05 |
Conditions
- Anaemia
Interventions
- IV trivalent saccharose hydroxide ferrous
- Oral ferrous fumarate
- Oral and intravenous Placebo
Primary outcomes
- Haemoglobin and Hematocrit values — 2 years
The objective was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact on the transfusion rate needing in Cardiovascular surgery under cardiopulmonary bypass
Countries
Spain