Oral and Intravenous Iron in Patients Postoperative Cardiovascular Surgery Under Extracorporeal Circulation - Full Text View

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:

MedlinePlus related topics: Anemia Blood Transfusion and Donation Iron

Drug Information available for: Sucrose Formic acid Ferrous fumarate

U.S. FDA Resources

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

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:

Reuler JB. Hypothermia: pathophysiology, clinical settings, and management. Ann Intern Med. 1978 Oct;89(4):519-27. Review.

Huyzen RJ, van Oeveren W, Wei F, Stellingwerf P, Boonstra PW, Gu YJ. In vitro effect of hemodilution on activated clotting time and high-dose thrombin time during cardiopulmonary bypass. Ann Thorac Surg. 1996 Aug;62(2):533-7.

Kirklin JW. Open-heart surgery at the Mayo Clinic. The 25th anniversary. Mayo Clin Proc. 1980 May;55(5):339-41. No abstract available.

Chenoweth DE, Cooper SW, Hugli TE, Stewart RW, Blackstone EH, Kirklin JW. Complement activation during cardiopulmonary bypass: evidence for generation of C3a and C5a anaphylatoxins. N Engl J Med. 1981 Feb 26;304(9):497-503.

Butler J, Rocker GM, Westaby S. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 1993 Feb;55(2):552-9. Review.

Fuhrer G, Gallimore MJ, Heller W, Hoffmeister HE. Aprotinin in cardiopulmonary bypass--effects on the Hageman factor (FXII)--Kallikrein system and blood loss. Blood Coagul Fibrinolysis. 1992 Feb;3(1):99-104.

Boyle EM Jr, Lille ST, Allaire E, Clowes AW, Verrier ED. Endothelial cell injury in cardiovascular surgery: atherosclerosis. Ann Thorac Surg. 1997 Mar;63(3):885-94. Review.

[No authors listed] Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. N Engl J Med. 1987 Jul 23;317(4):249-51. No abstract available.

Bracey AW, Radovancevic R, Riggs SA, Houston S, Cozart H, Vaughn WK, Radovancevic B, McAllister HA Jr, Cooley DA. Lowering the hemoglobin threshold for transfusion in coronary artery bypass procedures: effect on patient outcome. Transfusion. 1999 Oct;39(10):1070-7.

Fishbane S, Kowalski EA. The comparative safety of intravenous iron dextran, iron saccharate, and sodium ferric gluconate. Semin Dial. 2000 Nov-Dec;13(6):381-4. Review.

Rohling RG, Zimmermann AP, Breymann C. Intravenous versus oral iron supplementation for preoperative stimulation of hemoglobin synthesis using recombinant human erythropoietin. J Hematother Stem Cell Res. 2000 Aug;9(4):497-500.

Madi-Jebara SN, Sleilaty GS, Achouh PE, Yazigi AG, Haddad FA, Hayek GM, Antakly MC, Jebara VA. Postoperative intravenous iron used alone or in combination with low-dose erythropoietin is not effective for correction of anemia after cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Feb;18(1):59-63.

Goodnough LT, Skikne B, Brugnara C. Erythropoietin, iron, and erythropoiesis. Blood. 2000 Aug 1;96(3):823-33. Review.

Andrews NC. Disorders of iron metabolism. N Engl J Med. 1999 Dec 23;341(26):1986-95. Review. No abstract available. Erratum in: N Engl J Med 2000 Feb 3;342(5):364.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Garrido-Martín P, Nassar-Mansur MI, de la Llana-Ducrós R, Virgos-Aller TM, Fortunez PM, Ávalos-Pinto R, Jimenez-Sosa A, Martínez-Sanz R. The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial. Interact Cardiovasc Thorac Surg. 2012 Dec;15(6):1013-8. doi: 10.1093/icvts/ivs344. Epub 2012 Aug 31.

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:

Anemia
Hematologic Diseases
Ferrous fumarate
Iron
Trace Elements

Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013