Title
Oral and Intravenous Iron in Patients Postoperative Cardiovascular Surgery Under Extracorporeal Circulation
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
Phase
Phase 4Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
AnaemiaIntervention/Treatment
ferrous fumarate iron sucrose ...Study Participants
159Anaemia 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.
Preoperative Period 5-10 days 200 mg Iron iv (Venofer® )in 200cc physiologic solution /24-48h x 3 dosis +1 oral placebo /24h Postoperative Period 1-3weeks 200 mg Iron iv (Venofer® )in 200cc physiologic solution/24-48h x 3 dosis + 1 oral placebo /24h One month Follow-up 1 month 1 oral placebo /24h
200cc physiologic solution iv placebo /24-48h x 3 dosis + 1 oral iron tablet/24h (Ferogradumet®) Postoperative Period: 200cc physiologic solution iv placebo /24-48h x 3 dosis + 1 oral iron tablet/24h (Ferogradumet®) One month Follow-up: 1 oral iron tablet/24h Ferogradumet
Preoperative Period:1oral placebo/24h Postoperative Period:200cc physiologic solution iv placebo /24-48h x 3 dosis + 1oral placebo/24h One month Follow-up:1 oral placebo/24h
Inclusion Criteria: Men and women ≥ 18 years of age Patients subject to elective cardiac surgery under extracorporeal circulation Patients without previous anaemia, susceptible of treatment Patients without need of blood transfusion preoperative Patients providing written informed consent Patients who are able to complete all study visits per protocol Exclusion Criteria: Patients subject to elective cardiac surgery, but without extracorporeal circulation Patients who were treated with fibrinolytic therapy 48 hours before the surgery Patients with history of impaired renal function, (e.g., calculated creatinine clearance <50 mL/min/1.73 m2) Patients operated of active endocarditis Redo-surgery patients Women who are pregnant or lactating Patients with clinical of digestive bleeding Patients with vitamin B12 deficit Patients with ferropenic anaemia Patients with clinical history of asthma or allergy Patients with active infection Patients who are included in another clinical study Patients with hepatic disease Patients with history of allergy to iron Patients unlikely to adhere to protocol follow-up
