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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Canaria Rafael Clavijo para la Investigación Biomédica
• Treatments: Ferrous fumarate; Iron

Criteria

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