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NCT Number: NCT01078818

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

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.

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Key information

Conditions

Anaemia Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, 38320, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV trivalent saccharose hydroxide ferrous

Drug

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

Oral ferrous fumarate

Drug

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

Oral and intravenous Placebo

Drug

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 outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 2, 2010
Registry last updated
Mar 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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