Clinical trial NCT01078818: Oral and Intravenous Iron in Patients Postoperative Cardiovascular Surgery Under Extracorporeal Circulation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anaemia
Keywords: Cardiac surgery
Extracorporeal circulation
Anaemia
Intravenous iron
Oral Iron
Lead sponsor: Fundación Canaria Rafael Clavijo para la Investigación Biomédica
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Haemoglobin and Hematocrit values
timeFrame: 2 years
Secondary outcomes:
measure: need for hemoderived blood transfusions, postoperative stay and hospital costs
timeFrame: 2 years
Other outcomes:
Locations:
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz de Tenerife
Study officials:
affiliation: Hospital Universitario de Canarias
name: Pilar Garrido, MD
role: STUDY_DIRECTOR
References:
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