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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anaemia

Intervention / Treatment
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* Drug: IV trivalent saccharose hydroxide ferrous
* Drug: Oral ferrous fumarate
* Drug: Oral and intravenous Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV trivalent saccharose hydroxide ferrous<br> | Drug: IV trivalent saccharose hydroxide ferrous<br>* 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<br>* Other names: Venofer;|
| Active Comparator: Oral ferrous fumarate<br> | Drug: Oral ferrous fumarate<br>* 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<br>|
| Placebo Comparator: Oral and intravenous Placebo<br> | Drug: Oral and intravenous Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Extracorporeal circulation, Anaemia, Intravenous iron, Oral Iron