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RECRUITING
NCT06542393
PHASE2

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

Sponsor: Federal University of São Paulo

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-06-01

Completion Date

2026-06-01

Last Updated

2024-08-07

Healthy Volunteers

Yes

Interventions

DRUG

Erythropoietin

* 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.

PROCEDURE

blood transfusion

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.

Locations (1)

Leonardo Ohashi

São Paulo, São Paulo, Brazil