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

ConditionsAnemiaCoronary DiseaseCoronary Artery DiseaseCoronary StenosisCoronary OcclusionSystemic Inflammatory ResponseBleedingEpigenetic Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFederal University of São Paulo

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Eletive surgery;

Only CABG as procedure;

Off pump CABG candidate.

Disqualifiers

Age > 80 years;

Chronic dialytic kidney disease;

Chronic rheumatologic disease;

Men with Hb levels > 13 g/dl and < 8g/dl;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erythropoietin

    Drug

    * 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 transfusion

    Procedure/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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Randomized Anemia Group for non-PBM protocol (GNPBM)Experimental treatment 1 intervention
Group B: Randomized Anemia Group for PBM protocol (GPBM)Experimental treatment 1 intervention
Group C: Control Group (GC)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Mean number of units of Red Blood Cells (RBC)

Compare the need of blood transfusion in the perioperative period

Time frame
Until perioperative day 3

Secondary outcomes

1

Length of ICU stay

Hours

Time frame
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

Time frame
From time of ICU medical discharge until time of Hospital discharge (Up to 14 days).
3

Length of mechanical ventilation

Hours

Time frame
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

Time frame
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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Federal University of São Paulo

Lead sponsor

Fundação de Amparo à Pesquisa do Estado de São Paulo

Collaborator

Source ClinicalTrials.gov
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