NCT06542393 PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG)
| NCT ID | NCT06542393 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Federal University of São Paulo |
| Condition | Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2024-06-01 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Eletive surgery; * Only CABG as procedure; * Off pump CABG candidate. Exclusion Criteria: * 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; * 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%.
Frequently Asked Questions
Who can join the NCT06542393 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06542393 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06542393 currently recruiting?
Yes, NCT06542393 is actively recruiting participants. Visit ClinicalTrials.gov or contact Federal University of São Paulo to inquire about joining.
Where is the NCT06542393 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06542393 clinical trial?
NCT06542393 is sponsored by Federal University of São Paulo. The trial plans to enroll 120 participants.