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

Fundación Canaria Rafael Clavijo para la Investigación Biomédica159 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

159

Conditions

Anaemia

Interventions

IV trivalent saccharose hydroxide ferrousDRUG

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

Oral ferrous fumarateDRUG

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

Oral and intravenous PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

Outcomes

Primary Outcomes

Haemoglobin and Hematocrit values

The objective was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact on the transfusion rate needing in Cardiovascular surgery under cardiopulmonary bypass

Time frame: 2 years

Secondary Outcomes

need for hemoderived blood transfusions, postoperative stay and hospital costs

The objective was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact on the transfusion rate needing in Cardiovascular surgery under cardiopulmonary bypass

Time frame: 2 years

Data from ClinicalTrials.gov

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