Leonardo Ohashi
São Paulo, 04024-002, Brazil
Location status: Recruiting
Location contact
ISABEL CESPEDES, PhD
CONTACT
LEONARDO OHASHI, MD
CONTACT
NCT Number: NCT06542393
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 2
São Paulo, 04024-002, Brazil
Location status: Recruiting
ISABEL CESPEDES, PhD
CONTACT
LEONARDO OHASHI, MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Until perioperative day 3
Compare the need of blood transfusion in the perioperative period
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.
Hours
Time frame: From time of ICU medical discharge until time of Hospital discharge (Up to 14 days).
Days
Time frame: From time of intubation by anesthesia team until time of extubation by ICU team (Up to 240 hours).
Hours
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).
Needing of dyalisis in peoperative period
Time frame: Until perioperative day 3
Anytype
Time frame: From time of admission on ICU until hour 24th after admission (accountable amount from how many chest tubes the patient was admitted).
Thorax drain tubes bleeding (ml)
Time frame: Until perioperative day 3
. Differentially methylated regions (DMRs) and differentially methylated loci (DMLs) will be considered to determine if these regions are hypermethylated or hypomethylated in the comparison between groups.
Time frame: Until perioperative day 3
A total of 25 μl of serum per patient will be used for the detection of the following analytes: IL-1β, IL-6, IL-10, TNF-α, CRP, and NT-ProBNP.
Time frame: Until perioperative day 3
According to type 5 Myocardial ischemia
Time frame: Until perioperative day 3
Any level of neurological deficit
Time frame: Until perioperative day 3 and at discharge
Accountable in g/dl
Time frame: 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).
Death from any cause accountable as in-hospital mortality
Time frame: 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).)
any cardiovascular reason as main cause of death accountable as in-hospital mortality
Federal University of São Paulo
Other
Patient Blood Manegement (PBM) as Perioperative Strategy to Anemic Patients Who Will be Submitted to Coronary Artery Bypass Graft (CABG).
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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