Oral and Intravenous Iron in Patients Postoperative Cardiovascular Surgery Under Extracorporeal Circulation

Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Status and phase

Completed

Phase 4

Conditions

Anaemia

Treatments

Drug: Oral and intravenous Placebo

Drug: Oral ferrous fumarate

Drug: IV trivalent saccharose hydroxide ferrous

Study type

Interventional

Funder types

Other

Identifiers

NCT01078818

Tratamiento con hierro/2007

Details and patient eligibility

About

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.

Full description

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.

Enrollment

159 patients

Sex

All

Ages

18 to 78 years old

Volunteers

No Healthy Volunteers

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