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AnemiaPhase 2NCT06542393

PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG)

A Phase 2 study testing Erythropoietin and blood transfusion in people with Anemia and Coronary Disease, run by Federal University of São Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Anemia poses risks during coronary artery bypass grafting (CABG), increasing complications and mortality rates. Blood transfusions in cardiac surgery have negative outcomes, prompting the use of erythropoietin in Patient Blood Management (PBM) to limit transfusion needs and enhance postoperative recovery. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Anemia, Coronary Disease, Coronary Artery Disease
What is being tested?
Erythropoietin and blood transfusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteBrazil
Study dates
1 Jun 2024to 1 Jun 2026
Phase
Phase 2
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 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Eletive surgery;
  • Only CABG as procedure;
  • Off pump CABG candidate.

Who cannot join

  • Age > 80 years;
  • Chronic dialytic kidney disease;
  • Chronic rheumatologic disease;
  • Men with Hb levels > 13 g/dl and < 8g/dl;
  • Women with Hb levels > 12 g/dl and < 8g/dl;
  • Presence of another heart disease requiring surgical intervention;
Show all 14Show fewer
  • Presence of hepatic insufficiency;
  • Presence of any implantable electronic cardiac device in any cardiac chambers;
  • Pregnancy;
  • Diagnosis of malignant neoplasia;
  • Thrombophilias;
  • Need for Erythropoietin treatment due to any other disease.
  • Recent ischemic event (< 3 months).
  • Ejection fraction <30%.

Trial locations and contacts

1 site in 1 country.

Brazil1 site, 1 recruiting

  • Leonardo Ohashi

    São Paulo, São Paulo, 04024-002

    ISABEL CESPEDES, PhD, 05511996895763, isabel.cespedes@unifesp.br

    LEONARDO OHASHI, MD, 05511970531919, leonardo.ohashi@unifesp.br

    Recruiting

Other trials in Brazil

About this study

Official title: Patient Blood Manegement (PBM) as Perioperative Strategy to Anemic Patients Who Will be Submitted to Coronary Artery Bypass Graft (CABG).

Anemia poses risks during coronary artery bypass grafting (CABG), increasing complications and mortality rates. Blood transfusions in cardiac surgery have negative outcomes, prompting the use of erythropoietin in Patient Blood Management (PBM) to limit transfusion needs and enhance postoperative recovery. EPO can reduce blood component requirements, adverse events, and inflammation in anemic CABG patients. A study aims to minimize transfusions through a PBM anemia treatment protocol for CABG patients, comparing outcomes in three groups: a Control Group (CG), a Non-PBM Group (NPBMG) treated with blood components, and a PBM Group (GPBM) treated with EPO. Parameters include post-op stay, mortality, cardiovascular events, non-cardiovascular events, ICU time, mechanical ventilation duration, vasoactive drug use, inflammatory responses, and cardiac cell death. Analysis will consider demographic and clinical factors, with expectations that GPBM will yield superior results compared to NPBMG and similar or better outcomes than CG.

Read the detailed description

Anemia increases the risk of postoperative complications and mortality in patients undergoing coronary artery bypass grafting (CABG). In addition, the use of blood transfusions during cardiac surgery is associated with adverse effects and unfavorable outcomes. To reduce the need for transfusions and improve post-operative results, erythropoietin is used as part of Patient Blood Management (PBM). In anemic patients undergoing CABG, the use of Erythropoietin (EPO) can eliminate the need for blood components during and after surgery, as well as reduce adverse events and inflammation. The objectives of the proposed study are to reduce or eliminate the number of transfusions in the intraoperative and postoperative context by means of a Patient Blood Management (PBM) anemia treatment protocol for anemic patients who will undergo Coronary Artery Bypass Graft Surgery (CABG). The proposed study is a prospective, non-controlled interventional study to be carried out with anemic patients awaiting CABG surgery at Hospital São Paulo. There will be three groups of 40 participants each: Control Group (CG) of non-anemic individuals preoperatively; Non- PBM Group (NPBMG) of anemic individuals preoperatively and treated with blood components according to need; PBM Group (GPBM) of anemic individuals preoperatively and treated with EPO. The following parameters will be compared: length of postoperative hospital stay; mortality; postoperative cardiovascular events: clinical stroke, perioperative infarction, surgical reoperation due to bleeding; non- cardiovascular events: surgical site-associated infection and acute renal dysfunction; time in postoperative intensive care; time on mechanical ventilation; need for vasoactive drug use; inflammatory process and intra- and postoperative cardiac cell death. Confounding factors such as demographic and clinical parameters will be included in the analysis. It is expected that the GPBM will obtain the best results in relation to the GNPBM, similar to or better than the CG.

Being tested
Erythropoietin, blood transfusion
Medical subject headings
Anemia, Coronary Disease, Coronary Artery Disease, Coronary Stenosis, Coronary Occlusion, Hemorrhage

What participants receive

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

  • ErythropoietinDrug

    • Treatment regimen for hospitalized patients awaiting non-urgent surgeries: Administer EPO 600 IU/kg/week via subcutaneous (SC) or intravenous (IV) route, followed by 300 IU/kg/day via SC or IV 10 days before surgery. If ferritin < 100 ng/dL, supplement with IV iron (Iron hydroxide up to 600 mg/week or Ferric carboxymaltose up to 1000 mg/week).
    • Treatment regimen for hospitalized patients awaiting non-urgent surgeries with less than 5 days until surgery: Administer 40000 UI of EPO intravenous (IV) attack and supplement with IV iron (Iron hydroxide up to 600 mg/week or Ferric carboxymaltose up to 2000 mg/week), then 300UI/Kg/day IV or SC of EPO until day of surgery.

  • blood transfusionProcedure or surgery

    After surgery, this group will receive one unit of RBC at the moment of ICU admission.

    Hb > 8 g/dl: 1 unit of RBC. HB < 8 g/dl: 2 units of RBC.

Study groups in NCT06542393
Study groupRoleWhat they receive
Randomized Anemia Group for non-PBM protocol (GNPBM)ExperimentalPatients > 18 years admitted to Hospital São Paulo for Coronary Artery Bypass Grafting (CABG) surgery who are hospitalized in the Cardiovascular Surgery department or another specialty unit and are anemic (Hemoglobin - Hb < 12g/dl in women and < 13g/dl in men)
Receives: Procedure: blood transfusion
Randomized Anemia Group for PBM protocol (GPBM)ExperimentalPatients >18 years admitted to Hospital São Paulo for Coronary Artery Bypass Grafting (CABG) surgery who are hospitalized in the Cardiovascular Surgery department or another specialty unit and are anemic (Hb < 12g/dl in women and < 13g/dl in men)
Receives: Drug: Erythropoietin
Control Group (GC)No interventionPatients > 18 years admitted to Hospital SãoPaulo for Coronary Artery Bypass Grafting (CABG) surgery who arehospitalized in the Cardiovascular Surgery department or another specialty unit and do not have anemia (Hb > 13g/dl in men and > 12g/dl in women)

What is being measured

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

  1. Mean number of units of Red Blood Cells (RBC)

    Compare the need of blood transfusion in the perioperative period

    Measured: Until perioperative day 3

Secondary outcomes (13)

  1. Length of ICU stay

    Hours

    Measured: From time of admission after surgery to time of clinical conditions of discharge (time of ICU medical discharge, not time of ICU room exit). Up to 240 hours.

  2. Length of hospital stay

    Days

    Measured: From time of ICU medical discharge until time of Hospital discharge (Up to 14 days).

  3. Length of mechanical ventilation

    Hours

    Measured: From time of intubation by anesthesia team until time of extubation by ICU team (Up to 240 hours).

  4. Need of Dyalisis (Acute Kidney Disease)

    Needing of dyalisis in peoperative period

    Measured: Based on KDIGO classification of Acute Kdney Injury, level III of the classification. (Up to 120 hours from ICU admission, accountable from the time Dyalisis is indicated).

  5. Perioperative infection

    Anytype

    Measured: Until perioperative day 3

  6. Bleeding

    Thorax drain tubes bleeding (ml)

    Measured: From time of admission on ICU until hour 24th after admission (accountable amount from how many chest tubes the patient was admitted).

  7. Epigenetics alterations

    . Differentially methylated regions (DMRs) and differentially methylated loci (DMLs) will be considered to determine if these regions are hypermethylated or hypomethylated in the comparison between groups.

    Measured: Until perioperative day 3

  8. Inflammatory response

    A total of 25 μl of serum per patient will be used for the detection of the following analytes: IL-1β, IL-6, IL-10, TNF-α, CRP, and NT-ProBNP.

    Measured: Until perioperative day 3

  9. Perioperative myocardial infarction

    According to type 5 Myocardial ischemia

    Measured: Until perioperative day 3

  10. Stroke

    Any level of neurological deficit

    Measured: Until perioperative day 3

  11. Hemoglobin levels

    Accountable in g/dl

    Measured: Until perioperative day 3 and at discharge

  12. All-cause mortality

    Death from any cause accountable as in-hospital mortality

    Measured: From day of the intervention (if intervention group) or from the moment of surgery (if control group) until day of hospital discharge (death from any cause accountable as in-hospital mortality).

  13. Cardiovascular mortality

    any cardiovascular reason as main cause of death accountable as in-hospital mortality

    Measured: From day of the intervention (if intervention group) or from the moment of surgery (if control group) until day of hospital discharge (any cardiovascular reason as main cause of death accountable as in-hospital mortality).)

Timeline

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

  1. First posted7 Aug 2024
  2. Study start1 Jun 2024
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2026 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized (intervention group) for anemic patients Non-randomized (control group) for non-anemic patients
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06542393
Sponsor's protocol ID
0009/2023
Status last verified
Aug 2024
First submitted
9 Jul 2024
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alghamdi AA, Albanna MJ, Guru V, Brister SJ. Does the use of erythropoietin reduce the risk of exposure to allogeneic blood transfusion in cardiac surgery? A systematic review and meta-analysis. J Card Surg. 2006 May-Jun;21(3):320-6. doi: 10.1111/j.1540-8191.2006.00241.x.

    PubMed 16684074

  • Althoff FC, Neb H, Herrmann E, Trentino KM, Vernich L, Fullenbach C, Freedman J, Waters JH, Farmer S, Leahy MF, Zacharowski K, Meybohm P, Choorapoikayil S. Multimodal Patient Blood Management Program Based on a Three-pillar Strategy: A Systematic Review and Meta-analysis. Ann Surg. 2019 May;269(5):794-804. doi: 10.1097/SLA.0000000000003095.

    PubMed 30418206

  • Anthes E. Evidence-based medicine: Save blood, save lives. Nature. 2015 Apr 2;520(7545):24-6. doi: 10.1038/520024a. No abstract available.

    PubMed 25832389

  • Bian XX, Yuan XS, Qi CP. Effect of recombinant human erythropoietin on serum S100B protein and interleukin-6 levels after traumatic brain injury in the rat. Neurol Med Chir (Tokyo). 2010;50(5):361-6. doi: 10.2176/nmc.50.361.

    PubMed 20505289

  • Avni T, Bieber A, Grossman A, Green H, Leibovici L, Gafter-Gvili A. The safety of intravenous iron preparations: systematic review and meta-analysis. Mayo Clin Proc. 2015 Jan;90(1):12-23. doi: 10.1016/j.mayocp.2014.10.007. Epub 2014 Oct 30.

    PubMed 25572192

  • Bogoyevitch MA. An update on the cardiac effects of erythropoietin cardioprotection by erythropoietin and the lessons learnt from studies in neuroprotection. Cardiovasc Res. 2004 Aug 1;63(2):208-16. doi: 10.1016/j.cardiores.2004.03.017.

    PubMed 15249178

  • Cho BC, Serini J, Zorrilla-Vaca A, Scott MJ, Gehrie EA, Frank SM, Grant MC. Impact of Preoperative Erythropoietin on Allogeneic Blood Transfusions in Surgical Patients: Results From a Systematic Review and Meta-analysis. Anesth Analg. 2019 May;128(5):981-992. doi: 10.1213/ANE.0000000000004005.

    PubMed 30649068

  • Engoren MC, Habib RH, Zacharias A, Schwann TA, Riordan CJ, Durham SJ. Effect of blood transfusion on long-term survival after cardiac operation. Ann Thorac Surg. 2002 Oct;74(4):1180-6. doi: 10.1016/s0003-4975(02)03766-9.

    PubMed 12400765

  • Farmer SL, Towler SC, Leahy MF, Hofmann A. Drivers for change: Western Australia Patient Blood Management Program (WA PBMP), World Health Assembly (WHA) and Advisory Committee on Blood Safety and Availability (ACBSA). Best Pract Res Clin Anaesthesiol. 2013 Mar;27(1):43-58. doi: 10.1016/j.bpa.2012.12.007.

    PubMed 23590915

  • Ferrario M, Arbustini E, Massa M, Rosti V, Marziliano N, Raineri C, Campanelli R, Bertoletti A, De Ferrari GM, Klersy C, Angoli L, Bramucci E, Marinoni B, Ferlini M, Moretti E, Raisaro A, Repetto A, Schwartz PJ, Tavazzi L. High-dose erythropoietin in patients with acute myocardial infarction: a pilot, randomised, placebo-controlled study. Int J Cardiol. 2011 Feb 17;147(1):124-31. doi: 10.1016/j.ijcard.2009.10.028. Epub 2009 Nov 10.

    PubMed 19906454

  • Haljan G, Maitland A, Buchan A, Arora RC, King M, Haigh J, Culleton B, Faris P, Zygun D. The erythropoietin neuroprotective effect: assessment in CABG surgery (TENPEAKS): a randomized, double-blind, placebo controlled, proof-of-concept clinical trial. Stroke. 2009 Aug;40(8):2769-75. doi: 10.1161/STROKEAHA.109.549436. Epub 2009 Jun 25.

    PubMed 19556536

  • Hayden SJ, Albert TJ, Watkins TR, Swenson ER. Anemia in critical illness: insights into etiology, consequences, and management. Am J Respir Crit Care Med. 2012 May 15;185(10):1049-57. doi: 10.1164/rccm.201110-1915CI. Epub 2012 Jan 26.

    PubMed 22281832

  • Hogan M, Klein AA, Richards T. The impact of anaemia and intravenous iron replacement therapy on outcomes in cardiac surgery. Eur J Cardiothorac Surg. 2015 Feb;47(2):218-26. doi: 10.1093/ejcts/ezu200. Epub 2014 May 13.

    PubMed 24824650

  • Jadwin DF, Fenderson PG, Friedman MT, Jenkins I, Shander A, Waters JH, Friedman A, Tesoriero E, Refaai MA, Shih AW, Awan T, Ngo AL, Perez JA, Reynolds JD. Determination of Unnecessary Blood Transfusion by Comprehensive 15-Hospital Record Review. Jt Comm J Qual Patient Saf. 2023 Jan;49(1):42-52. doi: 10.1016/j.jcjq.2022.10.006. Epub 2022 Nov 8.

    PubMed 36494267

  • Lin DM, Lin ES, Tran MH. Efficacy and safety of erythropoietin and intravenous iron in perioperative blood management: a systematic review. Transfus Med Rev. 2013 Oct;27(4):221-34. doi: 10.1016/j.tmrv.2013.09.001. Epub 2013 Oct 15.

    PubMed 24135037

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erythropoietin and blood transfusion in people with Anemia and Coronary Disease, run by Federal University of São Paulo at 1 site in Brazil.

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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 7 Aug 2024. 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 Brazil. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean number of units of Red Blood Cells (RBC) (time frame: Until perioperative day 3). 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 NCT06542393, which also lists 42 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 7 Aug 2024.

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