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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Erythropoietin
  * 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
• Процедура blood transfusion
  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.

Первичные конечные точки

• Mean number of units of Red Blood Cells (RBC) [Срок оценки: Until perioperative day 3]

Вторичные конечные точки (12)

• Length of ICU stay [Срок оценки: 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.]
• Length of hospital stay [Срок оценки: From time of ICU medical discharge until time of Hospital discharge (Up to 14 days).]
• Length of mechanical ventilation [Срок оценки: From time of intubation by anesthesia team until time of extubation by ICU team (Up to 240 hours).]
• Need of Dyalisis (Acute Kidney Disease) [Срок оценки: 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).]
• Perioperative infection [Срок оценки: Until perioperative day 3]
• Bleeding [Срок оценки: From time of admission on ICU until hour 24th after admission (accountable amount from how many chest tubes the patient was admitted).]
• Epigenetics alterations [Срок оценки: Until perioperative day 3]
• Inflammatory response [Срок оценки: Until perioperative day 3]
• Perioperative myocardial infarction [Срок оценки: Until perioperative day 3]
• Stroke [Срок оценки: Until perioperative day 3]
• Hemoglobin levels [Срок оценки: Until perioperative day 3 and at discharge]
• All-cause mortality [Срок оценки: 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).]

Критерии участия

Критерии включения

• Eletive surgery;
• Only CABG as procedure;
• Off pump CABG candidate.

Критерии исключения

• 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%.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Leonardo Ohashi — São Paulo

Публикации

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• Althoff FC, Neb H, Herrmann E, Trentino KM, Vernich L, Fullenbach C, Freedman J, Waters JH, Farmer S, Leahy MF, Zacharowski K, Meybohm P, Choorapoikayil S. Multimodal Patient Blood Management Program Based on a Three-pillar Strategy: A Systematic Review and Meta-analysis. Ann Surg. 2019 May;269(5):794-804. doi: 10.1097/SLA.0000000000003095. PMID 30418206
• Anthes E. Evidence-based medicine: Save blood, save lives. Nature. 2015 Apr 2;520(7545):24-6. doi: 10.1038/520024a. No abstract available. PMID 25832389
• Bian XX, Yuan XS, Qi CP. Effect of recombinant human erythropoietin on serum S100B protein and interleukin-6 levels after traumatic brain injury in the rat. Neurol Med Chir (Tokyo). 2010;50(5):361-6. doi: 10.2176/nmc.50.361. PMID 20505289
• Avni T, Bieber A, Grossman A, Green H, Leibovici L, Gafter-Gvili A. The safety of intravenous iron preparations: systematic review and meta-analysis. Mayo Clin Proc. 2015 Jan;90(1):12-23. doi: 10.1016/j.mayocp.2014.10.007. Epub 2014 Oct 30. PMID 25572192
• Bogoyevitch MA. An update on the cardiac effects of erythropoietin cardioprotection by erythropoietin and the lessons learnt from studies in neuroprotection. Cardiovasc Res. 2004 Aug 1;63(2):208-16. doi: 10.1016/j.cardiores.2004.03.017. PMID 15249178
• Cho BC, Serini J, Zorrilla-Vaca A, Scott MJ, Gehrie EA, Frank SM, Grant MC. Impact of Preoperative Erythropoietin on Allogeneic Blood Transfusions in Surgical Patients: Results From a Systematic Review and Meta-analysis. Anesth Analg. 2019 May;128(5):981-992. doi: 10.1213/ANE.0000000000004005. PMID 30649068
• Engoren MC, Habib RH, Zacharias A, Schwann TA, Riordan CJ, Durham SJ. Effect of blood transfusion on long-term survival after cardiac operation. Ann Thorac Surg. 2002 Oct;74(4):1180-6. doi: 10.1016/s0003-4975(02)03766-9. PMID 12400765

Идентификаторы

NCT: NCT06542393 · 0009/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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