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AnemiaPhase 3EPICURENCT02390102

Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement

A Phase 3 study testing Erythropoietin in people with Anemia and Aortic Stenosis, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Anemia, Aortic Stenosis
What is being tested?
Erythropoietin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
117 participants
Where
1 siteCanada
Study dates
Jun 2012to Jun 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients ≥60-year old
  • Symptomatic aortic stenosis with a clinical indication for transcatheter aortic valve replacement, regardless of simultaneous percutaneous coronary intervention
  • Anemia defined according to the World Health Organization (WHO) definition 69:
  • Men: Hemoglobin<130 g/L
  • Women: <120 g/L

Who cannot join

  • Contraindication for transcatheter aortic valve replacement.
  • Erythropoietin treatment within last 30 days before Aortic Valve Replacement
  • Known anemia due to aplasia, other hemoglobinopathy or active bleeding requiring blood transfusion within last 30 days before Aortic Valve Replacement
  • Ferritin>800 µg/L
  • Uncontrolled hypertension (Blood pressure>175/95 )
  • Platelet count>450,000/L
Show all 12Show fewer
  • Recent myocardial infarction requiring percutaneous coronary intervention or disabling stroke (within the last 30 days)
  • Dialysis patients
  • 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
  • Active cancer or very high risk of thromboembolic events
  • Known allergy or hypersensitivity to intravenous iron or Erythropoietin therapy
  • No written consent

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    Québec, G1V 4G5

Other trials in Canada

About this study

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

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.

Read the 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).

Being tested
Erythropoietin, Placebo
Keywords
Anemia, Severe aortic stenosis, Red blood cell transfusion, Erythropoietin
Medical subject headings
Anemia, Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErythropoietinDrug

    Also called Darboepoetin

    Combinaison drug of darboepoetin 0.75µg/Kg + 200mg intravenous iron sucrose

  • PlaceboDrug

    Also called Saline solution

    Saline solution 0.9%

Study groups in NCT02390102
Study groupRoleWhat they receive
ErythropoietinActive comparatorDose: darboepoetin 0.75µg/Kg + 200mg intravenous iron sucrose Administered at days 10 (±4) and 1 (±1) before the index procedure.
Receives: Drug: Erythropoietin
PlaceboPlacebo comparatorDosage: Saline solution 0.9% Administered at days 10 (±4) and 1 (±1) before the index procedure.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of red blood cell transfusion

    Measured: 30 days

Secondary outcomes (13)

  1. Number of packets of red cells

    Measured: 30 days

  2. Hemoglobin value

    Analysis g/L

    Measured: One day before index procedure

  3. Hemoglobin value

    Measured: For the duration of hospital stay, an expected average of 1 week

  4. Peak of troponin and creatinine kinase

    Measured: For the duration of hospital stay, an expected average of 1 week

  5. Incidence of acute kidney injury

    Acute kidney injury defined as >25% decrease of estimated glomerular filtration rate (eGFR)

    Measured: At 48 hours following procedure

  6. Need of hemodialysis

    Measured: For the duration of hospital stay, an expected average of 1 week

  7. Rate of new onset atrial fibrillation

    Measured: For the duration of hospital stay, an expected average of 1 week

  8. Days of hospital stay

    Measured: For the duration of hospital stay, an expected average of 1 week

  9. Days of intensive unit care stay

    Measured: For the duration of hospital stay, an expected average of 1 week

  10. Mortality

    Measured: At 30-day, 1-year

  11. Quality of life

    Questionnaire, Visual scale

    Measured: At 30-day, 6-month, 1-year

  12. Cost-effectiveness analysis of Erythropoietin-therapy

    Measured: For the duration of hospital stay, an expected average of 1 week

  13. Stroke rate

    Measured: At 30-day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2015 (estimated)
  2. Study startJun 2012
  3. Primary completionJun 2015
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02390102
Sponsor's protocol ID
EPICURE
Other IDs
CER-20809
Acronym
EPICURE
Status last verified
Jul 2018
First submitted
21 Jan 2013
Last updated
17 Jul 2018
Results posted
No
Data monitoring committee
No

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.

    PubMed 18172032

  • 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. doi: 10.1161/CIRCULATIONAHA.106.653501. Epub 2007 Jul 9.

    PubMed 17620512

  • 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. doi: 10.1016/j.athoracsur.2005.03.137.

    PubMed 16181875

  • 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.

    PubMed 21646060

  • van Straten AH, Hamad MA, van Zundert AJ, Martens EJ, Schonberger 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.

    PubMed 19564556

  • 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.

    PubMed 21353044

  • Murphy GJ, Reeves BC, Rogers CA, Rizvi SI, Culliford L, Angelini GD. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007 Nov 27;116(22):2544-52. doi: 10.1161/CIRCULATIONAHA.107.698977. Epub 2007 Nov 12.

    PubMed 17998460

  • Bucerius J, Gummert JF, Borger MA, Walther T, Doll N, Onnasch JF, Metz S, Falk V, Mohr FW. Stroke after cardiac surgery: a risk factor analysis of 16,184 consecutive adult patients. Ann Thorac Surg. 2003 Feb;75(2):472-8. doi: 10.1016/s0003-4975(02)04370-9.

    PubMed 12607656

  • Paone G, Brewer R, Theurer PF, Bell GF, Cogan CM, Prager RL; Michigan Society of Thoracic and Cardiovascular Surgeons. Preoperative predicted risk does not fully explain the association between red blood cell transfusion and mortality in coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2012 Jan;143(1):178-85. doi: 10.1016/j.jtcvs.2011.09.015. Epub 2011 Oct 19.

    PubMed 22014719

  • Koch CG, Li L, Van Wagoner DR, Duncan AI, Gillinov AM, Blackstone EH. Red cell transfusion is associated with an increased risk for postoperative atrial fibrillation. Ann Thorac Surg. 2006 Nov;82(5):1747-56. doi: 10.1016/j.athoracsur.2006.05.045.

    PubMed 17062241

  • 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. doi: 10.1161/CIRCULATIONAHA.105.001271.

    PubMed 16820613

  • Bagur R, Webb JG, Nietlispach F, Dumont E, De Larochelliere R, Doyle D, Masson JB, Gutierrez MJ, Clavel MA, Bertrand OF, Pibarot P, Rodes-Cabau J. Acute kidney injury following transcatheter aortic valve implantation: predictive factors, prognostic value, and comparison with surgical aortic valve replacement. Eur Heart J. 2010 Apr;31(7):865-74. doi: 10.1093/eurheartj/ehp552. Epub 2009 Dec 27.

    PubMed 20037180

  • 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.

    PubMed 22027622

  • Kiyama H, Ohshima N, Imazeki T, Yamada T. Autologous blood donation with recombinant human erythropoietin in anemic patients. Ann Thorac Surg. 1999 Nov;68(5):1652-6. doi: 10.1016/s0003-4975(99)00755-9.

    PubMed 10585037

  • Sowade O, Warnke H, Scigalla P, Sowade B, Franke W, Messinger D, Gross J. Avoidance of allogeneic blood transfusions by treatment with epoetin beta (recombinant human erythropoietin) in patients undergoing open-heart surgery. Blood. 1997 Jan 15;89(2):411-8.

    PubMed 9002942

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erythropoietin in people with Anemia and Aortic Stenosis, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of red blood cell transfusion (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02390102, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.

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