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

NCT01078818 | Completed Phase 4

• 1 other identifier: Tratamiento con hierro/2007
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaemia

Keywords

Cardiac surgery; Extracorporeal circulation; Anaemia; Intravenous iron; Oral Iron

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (1)

• need for hemoderived blood transfusions, postoperative stay and hospital costs

  2 years

Study Arms (3)

IV trivalent saccharose hydroxide ferrous

EXPERIMENTAL

Drug: IV trivalent saccharose hydroxide ferrous

Oral ferrous fumarate

ACTIVE COMPARATOR

Drug: Oral ferrous fumarate

Oral and intravenous Placebo

PLACEBO COMPARATOR

Drug: Oral and intravenous Placebo

Interventions

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

Also known as: Venofer

IV trivalent saccharose hydroxide ferrous

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 ferrous fumarate

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

Oral and intravenous Placebo

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Canaria Rafael Clavijo para la Investigación Biomédica: lead

Study Sites (1)

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320, Spain

Location

Related Publications (15)

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  PMID: 358883 BACKGROUND

• 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.

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• 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. doi: 10.1056/NEJM198102263040901.

  PMID: 7453783 BACKGROUND

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  PMID: 8431082 BACKGROUND

• 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. doi: 10.1097/00001721-199202000-00014.

  PMID: 1377956 BACKGROUND

• 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. doi: 10.1016/s0003-4975(97)00057-x.

  PMID: 9066432 BACKGROUND

• Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. N Engl J Med. 1987 Jul 23;317(4):249-51. doi: 10.1056/NEJM198707233170416. No abstract available.

  PMID: 3600716 BACKGROUND

• 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. doi: 10.1046/j.1537-2995.1999.39101070.x.

  PMID: 10532600 BACKGROUND

• 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. doi: 10.1046/j.1525-139x.2000.00104.x.

  PMID: 11130261 BACKGROUND

• 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. doi: 10.1089/152581600419161.

  PMID: 10982248 BACKGROUND

• 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. doi: 10.1053/j.jvca.2003.10.012.

  PMID: 14973801 BACKGROUND

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

  PMID: 10910892 BACKGROUND

• Andrews NC. Disorders of iron metabolism. N Engl J Med. 1999 Dec 23;341(26):1986-95. doi: 10.1056/NEJM199912233412607. No abstract available.

  PMID: 10607817 BACKGROUND

• Garrido-Martin P, Nassar-Mansur MI, de la Llana-Ducros R, Virgos-Aller TM, Rodriguez Fortunez PM, Avalos-Pinto R, Jimenez-Sosa A, Martinez-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.

  PMID: 22940889 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Ferric Oxide, Saccharated; ferrous fumarate

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Pilar Garrido, MD

  Hospital Universitario de Canarias

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: May 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 3, 2010

Record last verified: 2007-05

Locations

ES (1)