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

This study has been completed.
Sponsor:
Information provided by:
Fundación Canaria Rafael Clavijo para la Investigación Biomédica
ClinicalTrials.gov Identifier:
NCT01078818
First received: March 1, 2010
Last updated: March 2, 2010
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Anaemia
Drug: IV trivalent saccharose hydroxide ferrous
Drug: Oral ferrous fumarate
Drug: Oral and intravenous Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fundación Canaria Rafael Clavijo para la Investigación Biomédica:

Primary Outcome Measures:
  • Haemoglobin and Hematocrit values [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • need for hemoderived blood transfusions, postoperative stay and hospital costs [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Enrollment: 159
Study Start Date: May 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

Other Name: Oral ferrous fumarate
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
Other Name: Oral and intravenous Placebo

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

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01078818

Locations
Spain
Hospital Universitario de Canarias
Tenerife, Santa Cruz de Tenerife, Spain, 38320
Sponsors and Collaborators
Fundación Canaria Rafael Clavijo para la Investigación Biomédica
Investigators
Study Director: Pilar Garrido, MD Hospital Universitario de Canarias
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pilar Garrido Martin MD, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
ClinicalTrials.gov Identifier: NCT01078818     History of Changes
Other Study ID Numbers: Tratamiento con hierro/2007
Study First Received: March 1, 2010
Last Updated: March 2, 2010
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundación Canaria Rafael Clavijo para la Investigación Biomédica:
Cardiac surgery
Extracorporeal circulation
Anaemia
Intravenous iron
Oral Iron

Additional relevant MeSH terms:
Iron
Ferrous fumarate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014