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Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement

Information source: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anemia; Aortic Stenosis

Intervention: Erythropoietin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Official(s) and/or principal investigator(s):
Josep Rodes Cabau, MD, Principal Investigator, Affiliation: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Summary

The objective of the study is to evaluate the efficacy of Erythropoietin (EPO) (+ iron) in reducing the rate of red blood cell transfusion requirements in patients with aortic stenosis undergoing transcatheter aortic valve replacement.

Clinical Details

Official title: Combined ErythroPoietin and Iron Therapy for AnemiC Patients With Severe Symptomatic Aortic Stenosis Undergoing Transcatheter Aortic Valve REplacement- The EPICURE Trial A Prospective Double Blind Randomized Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Rate of red blood cell transfusion

Secondary outcome:

Number of packets of red cells

Hemoglobin value

Hemoglobin value

Peak of troponin and creatinine kinase

Incidence of acute kidney injury

Need of hemodialysis

Rate of new onset atrial fibrillation

Days of hospital stay

Days of intensive unit care stay

Mortality

Quality of life

Cost-effectiveness analysis of Erythropoietin-therapy

Stroke rate

Detailed description: STUDY DESIGN Prospective randomized double blind study including patients diagnosed with severe symptomatic aortic stenosis and anemia undergoing aortic valve replacement. The patients will be identified in the cardiac surgery / aortic stenosis outpatient clinic or in the hospitalization department of the Institut Universitaire de Cardiologie et de Pneumologie de Quebec. SAMPLE SIZE 100 patients (50 patients per group).

Eligibility

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients ≥60-year old 2. Symptomatic aortic stenosis with a clinical indication for transcatheter aortic valve replacement, regardless of simultaneous percutaneous coronary intervention 3. Anemia defined according to the World Health Organization (WHO) definition 69: 1. Men: Hemoglobin<130 g/L 2. Women: <120 g/L Exclusion Criteria: 1. Contraindication for transcatheter aortic valve replacement. 2. Erythropoietin treatment within last 30 days before Aortic Valve Replacement 3. Known anemia due to aplasia, other hemoglobinopathy or active bleeding requiring blood transfusion within last 30 days before Aortic Valve Replacement 4. Ferritin>800 µg/L 5. Uncontrolled hypertension (Blood pressure>175/95 ) 6. Platelet count>450,000/L 7. Recent myocardial infarction requiring percutaneous coronary intervention or disabling stroke (within the last 30 days) 8. Dialysis patients 9. Hemodynamic instability as defined as the need of hemodynamic support with inotropic drugs, intraortic balloon pump counter-pulsation or left ventricular assist device before index procedure 10. Active cancer or very high risk of thromboembolic events 11. Known allergy or hypersensitivity to intravenous iron or Erythropoietin therapy 12. No written consent

Locations and Contacts

Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Quebec G1V 4G5, Canada; Recruiting
Melanie Cote, MSc, Phone: 418-656-8711, Ext: 2646, Email: melanie.cote@criucpq.ulaval.ca
Marina Urena, MD, Phone: 418-656-8711, Ext: 3484, Email: marinaua@hotmail.com
Josep Rodes Cabau, MD, Principal Investigator
Additional Information

Related publications:

Karkouti K, Wijeysundera DN, Beattie WS; Reducing Bleeding in Cardiac Surgery (RBC) Investigators. Risk associated with preoperative anemia in cardiac surgery: a multicenter cohort study. Circulation. 2008 Jan 29;117(4):478-84. doi: 10.1161/CIRCULATIONAHA.107.718353. Epub 2008 Jan 2.

Kulier A, Levin J, Moser R, Rumpold-Seitlinger G, Tudor IC, Snyder-Ramos SA, Moehnle P, Mangano DT; Investigators of the Multicenter Study of Perioperative Ischemia Research Group; Ischemia Research and Education Foundation. Impact of preoperative anemia on outcome in patients undergoing coronary artery bypass graft surgery. Circulation. 2007 Jul 31;116(5):471-9. Epub 2007 Jul 9.

Karkouti K, Djaiani G, Borger MA, Beattie WS, Fedorko L, Wijeysundera D, Ivanov J, Karski J. Low hematocrit during cardiopulmonary bypass is associated with increased risk of perioperative stroke in cardiac surgery. Ann Thorac Surg. 2005 Oct;80(4):1381-7.

Van Mieghem NM, Nuis RJ, Tzikas A, Piazza N, Schultz C, Serruys PW, de Jaegere PP. Prevalence and prognostic implications of baseline anaemia in patients undergoing transcatheter aortic valve implantation. EuroIntervention. 2011 Jun;7(2):184-91. doi: 10.4244/EIJV7I2A32.

van Straten AH, Hamad MA, van Zundert AJ, Martens EJ, Schönberger JP, de Wolf AM. Preoperative hemoglobin level as a predictor of survival after coronary artery bypass grafting: a comparison with the matched general population. Circulation. 2009 Jul 14;120(2):118-25. doi: 10.1161/CIRCULATIONAHA.109.854216. Epub 2009 Jun 29.

Society of Thoracic Surgeons Blood Conservation Guideline Task Force, Ferraris VA, Brown JR, Despotis GJ, Hammon JW, Reece TB, Saha SP, Song HK, Clough ER; Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion, Shore-Lesserson LJ, Goodnough LT, Mazer CD, Shander A, Stafford-Smith M, Waters J; International Consortium for Evidence Based Perfusion, Baker RA, Dickinson TA, FitzGerald DJ, Likosky DS, Shann KG. 2011 update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists blood conservation clinical practice guidelines. Ann Thorac Surg. 2011 Mar;91(3):944-82. doi: 10.1016/j.athoracsur.2010.11.078. Review.

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Surgenor SD, DeFoe GR, Fillinger MP, Likosky DS, Groom RC, Clark C, Helm RE, Kramer RS, Leavitt BJ, Klemperer JD, Krumholz CF, Westbrook BM, Galatis DJ, Frumiento C, Ross CS, Olmstead EM, O'Connor GT. Intraoperative red blood cell transfusion during coronary artery bypass graft surgery increases the risk of postoperative low-output heart failure. Circulation. 2006 Jul 4;114(1 Suppl):I43-8.

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Yoo YC, Shim JK, Kim JC, Jo YY, Lee JH, Kwak YL. Effect of single recombinant human erythropoietin injection on transfusion requirements in preoperatively anemic patients undergoing valvular heart surgery. Anesthesiology. 2011 Nov;115(5):929-37. doi: 10.1097/ALN.0b013e318232004b.

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Starting date: June 2012
Last updated: March 16, 2015

Page last updated: August 23, 2015

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