Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06542393

Patient Blood Management as a Perioperative Strategy for Anemic Patients Undergoing Coronary Artery Bypass Graft (CABG)

Led by Federal University of São Paulo · Updated on 2024-08-07

120

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

F

Federal University of São Paulo

Lead Sponsor

F

Fundação de Amparo à Pesquisa do Estado de São Paulo

Collaborating Sponsor

AI-Summary

What this Trial Is About

Anemia increases risks during coronary artery bypass grafting (CABG), leading to more complications and higher mortality. Blood transfusions during cardiac surgery can cause negative outcomes, so erythropoietin (EPO) is studied as part of Patient Blood Management (PBM) to reduce transfusion needs and improve recovery. This Phase 2 study compares three groups: non-anemic controls, anemic patients treated with blood transfusions, and anemic patients treated with EPO, to assess various clinical and inflammatory outcomes. Participants are assigned to one of three groups: a Control Group of non-anemic patients, a Non-PBM Group receiving blood transfusions as needed, and a PBM Group treated with EPO before surgery. EPO is given via subcutaneous or intravenous routes with specific dosing schedules depending on time before surgery and iron supplementation if needed. The Non-PBM group receives red blood cell transfusions after surgery based on hemoglobin levels. The study focuses on reducing or eliminating transfusions in the perioperative period. During the study, researchers will measure the average number of red blood cell units given until three days after surgery, length of ICU and hospital stays, mechanical ventilation time, need for dialysis, bleeding, infections, inflammatory and epigenetic changes, cardiac events like stroke and myocardial infarction, hemoglobin levels, and mortality. The study also considers demographic and clinical factors. Participants are followed from surgery until hospital discharge to evaluate these outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled for elective surgery
  • Only undergoing coronary artery bypass grafting (CABG)
  • Candidate for off-pump CABG
  • Aged between 18 and 80 years
Not Eligible

You will not qualify if you...

  • Age over 80 years
  • Chronic dialytic kidney disease
  • Chronic rheumatologic disease
  • Men with hemoglobin levels above 13 g/dl or below 8 g/dl
  • Women with hemoglobin levels above 12 g/dl or below 8 g/dl
  • Presence of other heart diseases requiring surgery
  • Hepatic insufficiency
  • Presence of any implantable electronic cardiac device
  • Pregnancy
  • Diagnosis of malignant neoplasia
  • Thrombophilias
  • Need for erythropoietin treatment due to other diseases
  • Recent ischemic event within the last 3 months
  • Ejection fraction below 30%

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 10 days before surgery and perioperative period

Participants receive erythropoietin and iron supplementation as part of Patient Blood Management prior to surgery and undergo coronary artery bypass graft (CABG) surgery. Some participants receive blood transfusions after surgery as needed.

Multiple visits during preoperative treatment and hospital stay for surgery and postoperative care

Follow-up

Duration - Up to 14 days after surgery

Participants are monitored postoperatively for up to 14 days to assess outcomes such as length of ICU and hospital stay, need for mechanical ventilation, infections, bleeding, and mortality.

Daily monitoring visits during hospital stay

Trial Site Locations

Total: 1 location

1

Leonardo Ohashi

São Paulo, São Paulo, Brazil, 04024-002

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Does the use of erythropoietin reduce the risk of exposure to allogeneic blood transfusion in cardiac surgery? A systematic review and meta-analysis.

Abdullah A Alghamdi, Mohammad J Albanna, Veena Guru...

https://pubmed.ncbi.nlm.nih.gov/16684074

Multimodal Patient Blood Management Program Based on a Three-pillar Strategy: A Systematic Review and Meta-analysis.

Friederike C Althoff, Holger Neb, Eva Herrmann...

https://pubmed.ncbi.nlm.nih.gov/30418206

Effect of recombinant human erythropoietin on serum S100B protein and interleukin-6 levels after traumatic brain injury in the rat.

Xiao-xing Bian, Xue-song Yuan, Chuan-ping Qi

https://pubmed.ncbi.nlm.nih.gov/20505289

An update on the cardiac effects of erythropoietin cardioprotection by erythropoietin and the lessons learnt from studies in neuroprotection.

Marie A Bogoyevitch

https://pubmed.ncbi.nlm.nih.gov/15249178

Impact of Preoperative Erythropoietin on Allogeneic Blood Transfusions in Surgical Patients: Results From a Systematic Review and Meta-analysis.

Brian C Cho, Jessica Serini, Andres Zorrilla-Vaca...

https://pubmed.ncbi.nlm.nih.gov/30649068

Drivers for change: Western Australia Patient Blood Management Program (WA PBMP), World Health Assembly (WHA) and Advisory Committee on Blood Safety and Availability (ACBSA).

Shannon L Farmer, Simon C Towler, Michael F Leahy...

https://pubmed.ncbi.nlm.nih.gov/23590915

High-dose erythropoietin in patients with acute myocardial infarction: a pilot, randomised, placebo-controlled study.

Maurizio Ferrario, Eloisa Arbustini, Margherita Massa...

https://pubmed.ncbi.nlm.nih.gov/19906454