Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06542393

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

Erythropoietin

Drug
  • 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.

Blood Transfusion

Procedure

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.

Primary outcomes

  1. Mean number of units of Red Blood Cells (RBC)

    Time frame: Until perioperative day 3

    Compare the need of blood transfusion in the perioperative period

Secondary outcomes

  1. Length of ICU stay

    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

  2. Length of hospital stay

    Time frame: From time of ICU medical discharge until time of Hospital discharge (Up to 14 days).

    Days

  3. Length of mechanical ventilation

    Time frame: From time of intubation by anesthesia team until time of extubation by ICU team (Up to 240 hours).

    Hours

  4. Need of Dyalisis (Acute Kidney Disease)

    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

  5. Perioperative infection

    Time frame: Until perioperative day 3

    Anytype

  6. Bleeding

    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)

  7. Epigenetics alterations

    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.

  8. Inflammatory response

    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.

  9. Perioperative myocardial infarction

    Time frame: Until perioperative day 3

    According to type 5 Myocardial ischemia

  10. Stroke

    Time frame: Until perioperative day 3

    Any level of neurological deficit

  11. Hemoglobin levels

    Time frame: Until perioperative day 3 and at discharge

    Accountable in g/dl

  12. All-cause 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 (death from any cause accountable as in-hospital mortality).

    Death from any cause accountable as in-hospital mortality

  13. Cardiovascular 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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.