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

March 2, 2010 updated by: Fundación Canaria Rafael Clavijo para la Investigación Biomédica

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Santa Cruz de Tenerife
      • Tenerife, Santa Cruz de Tenerife, Spain, 38320
        • Hospital Universitario de Canarias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV trivalent saccharose hydroxide ferrous
Drug: IV trivalent saccharose hydroxide ferrous

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

Other Names:
  • Venofer
Active Comparator: Oral ferrous fumarate
Drug: Oral ferrous fumarate

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
Placebo Comparator: Oral and intravenous Placebo
Drug: Oral and intravenous Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemoglobin and Hematocrit values
Time Frame: 2 years
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
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Investigators

  • Study Director: Pilar Garrido, MD, Hospital Universitario de Canarias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

March 3, 2010

Last Update Submitted That Met QC Criteria

March 2, 2010

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tratamiento con hierro/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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