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

Last updated: August 4, 2024
Sponsor: Federal University of São Paulo
Overall Status: Active - Recruiting

Phase

2

Condition

Coronary Artery Disease

Anemia

Chest Pain

Treatment

blood transfusion

Erythropoietin

Clinical Study ID

NCT06542393
0009/2023
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Eletive surgery;

  • Only CABG as procedure;

  • Off pump CABG candidate.

Exclusion

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%.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: blood transfusion
Phase: 2
Study Start date:
June 01, 2024
Estimated Completion Date:
June 01, 2026

Study 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.

Connect with a study center

  • Leonardo Ohashi

    São Paulo, SAO Paulo 04024-002
    Brazil

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.