Clinical trial NCT06542393: PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG)
Official title: Patient Blood Manegement (PBM) as Perioperative Strategy to Anemic Patients Who Will be Submitted to Coronary Artery Bypass Graft (CABG).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Anemia
Coronary Disease
Coronary Artery Disease
Coronary Stenosis
Coronary Occlusion
Systemic Inflammatory Response
Bleeding
Epigenetic Disorder
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2024-08-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized (intervention group) for anemic patients Non-randomized (control group) for non-anemic patients
Primary purpose: TREATMENT

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.

Detailed 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.

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%.

Primary outcomes:
measure: Mean number of units of Red Blood Cells (RBC)
timeFrame: Until perioperative day 3
Secondary outcomes:
measure: Length of ICU stay
timeFrame: 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.
measure: Length of hospital stay
timeFrame: From time of ICU medical discharge until time of Hospital discharge (Up to 14 days).
measure: Length of mechanical ventilation
timeFrame: From time of intubation by anesthesia team until time of extubation by ICU team (Up to 240 hours).
measure: Need of Dyalisis (Acute Kidney Disease)
timeFrame: 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).
measure: Perioperative infection
timeFrame: Until perioperative day 3
measure: Bleeding
timeFrame: From time of admission on ICU until hour 24th after admission (accountable amount from how many chest tubes the patient was admitted).
measure: Epigenetics alterations
timeFrame: Until perioperative day 3
measure: Inflammatory response
timeFrame: Until perioperative day 3
measure: Perioperative myocardial infarction
timeFrame: Until perioperative day 3
measure: Stroke
timeFrame: Until perioperative day 3
measure: Hemoglobin levels
timeFrame: Until perioperative day 3 and at discharge
measure: All-cause mortality
timeFrame: From day of the intervention (if intervention group) or from the moment of surgery (if control group) until day of hospital discharge (death from any cause accountable as in-hospital mortality).
measure: Cardiovascular mortality
timeFrame: From day of the intervention (if intervention group) or from the moment of surgery (if control group) until day of hospital discharge (any cardiovascular reason as main cause of death accountable as in-hospital mortality).)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Leonardo Ohashi
state: SAO Paulo
Study officials:
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