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

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ClinicalTrials.gov Identifier: NCT01078818
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : March 3, 2010
Sponsor:
Information provided by:
Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Tracking Information
First Submitted Date  ICMJE March 1, 2010
First Posted Date  ICMJE March 2, 2010
Last Update Posted Date March 3, 2010
Study Start Date  ICMJE May 2007
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2010)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral and Intravenous Iron in Patients Postoperative Cardiovascular Surgery Under Extracorporeal Circulation
Official Title  ICMJE 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
Brief Summary 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

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anaemia
Intervention  ICMJE
  • 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

  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2010)
159
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 78 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01078818
Other Study ID Numbers  ICMJE Tratamiento con hierro/2007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pilar Garrido Martin MD, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
Study Sponsor  ICMJE Fundación Canaria Rafael Clavijo para la Investigación Biomédica
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pilar Garrido, MD Hospital Universitario de Canarias
PRS Account Fundación Canaria Rafael Clavijo para la Investigación Biomédica
Verification Date May 2007

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