Anaemia Clinical Trial
Official title:
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.
Prospective double dummy triple blind study of 159 patients undergoing CPB; randomised in 3
groups treated with iron intravenously (iv) (group I), with iron orally (group II)
controlled with placebo (group III). Patients from group I were treated with iv Iron sucrose
, three doses of 100 mg of iv iron every 24 hours during postoperative hospitalization and 1
pill/24 h of oral placebo during the first month after discharge. Group II was programmed to
receive 1 iron pill orally every 24 hours pre and postoperatively and up to one month after
discharge and a placebo while hospitalized. Group III was programmed to receive an oral and
iv placebo pre and postoperatively.
Variables were collected preoperatively, at operation room and at Intensive Care Unit
admission and discharge, at postoperative floor discharge and at one month after surgical
discharge.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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