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

Primary Purpose

Anaemia

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
IV trivalent saccharose hydroxide ferrous
Oral ferrous fumarate
Oral and intravenous Placebo
Sponsored by
Fundación Canaria Rafael Clavijo para la Investigación Biomédica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaemia focused on measuring Cardiac surgery, Extracorporeal circulation, Anaemia, Intravenous iron, Oral Iron

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario de Canarias

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

IV trivalent saccharose hydroxide ferrous

Oral ferrous fumarate

Oral and intravenous Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 1, 2010
Last Updated
March 2, 2010
Sponsor
Fundación Canaria Rafael Clavijo para la Investigación Biomédica
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1. Study Identification

Unique Protocol Identification Number
NCT01078818
Brief Title
Oral and Intravenous Iron in Patients Postoperative Cardiovascular Surgery Under Extracorporeal Circulation
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fundación Canaria Rafael Clavijo para la Investigación Biomédica

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaemia
Keywords
Cardiac surgery, Extracorporeal circulation, Anaemia, Intravenous iron, Oral Iron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV trivalent saccharose hydroxide ferrous
Arm Type
Experimental
Arm Title
Oral ferrous fumarate
Arm Type
Active Comparator
Arm Title
Oral and intravenous Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
IV trivalent saccharose hydroxide ferrous
Other Intervention Name(s)
Venofer
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Oral ferrous fumarate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Oral and intravenous Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Haemoglobin and Hematocrit values
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
need for hemoderived blood transfusions, postoperative stay and hospital costs
Description
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
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar Garrido, MD
Organizational Affiliation
Hospital Universitario de Canarias
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario de Canarias
City
Tenerife
State/Province
Santa Cruz de Tenerife
ZIP/Postal Code
38320
Country
Spain

12. IPD Sharing Statement

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

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