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

March 1, 2010
March 2, 2010
May 2007
May 2009   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01078818 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Oral and Intravenous Iron in Patients Postoperative Cardiovascular Surgery Under Extracorporeal Circulation
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anaemia
  • 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
  • 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
  • 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
  • Experimental: IV trivalent saccharose hydroxide ferrous
    Intervention: Drug: IV trivalent saccharose hydroxide ferrous
  • Active Comparator: Oral ferrous fumarate
    Intervention: Drug: Oral ferrous fumarate
  • Placebo Comparator: Oral and intravenous Placebo
    Intervention: Drug: Oral and intravenous Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 78 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01078818
Tratamiento con hierro/2007
No
Pilar Garrido Martin MD, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
Fundación Canaria Rafael Clavijo para la Investigación Biomédica
Not Provided
Study Director: Pilar Garrido, MD Hospital Universitario de Canarias
Fundación Canaria Rafael Clavijo para la Investigación Biomédica
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP