Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-03 @ 5:10 PM
Study NCT ID:
NCT06542393
Status:
RECRUITING
Last Update Posted:
2024-08-07
First Post:
2024-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}, {'id': 'D054059', 'term': 'Coronary Occlusion'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D001803', 'term': 'Blood Transfusion'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized (intervention group) for anemic patients Non-randomized (control group) for non-anemic patients'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-04', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-08-04', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean number of units of Red Blood Cells (RBC)', 'timeFrame': 'Until perioperative day 3', 'description': 'Compare the need of blood transfusion in the perioperative period'}], 'secondaryOutcomes': [{'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.', 'description': 'Hours'}, {'measure': 'Length of hospital stay', 'timeFrame': 'From time of ICU medical discharge until time of Hospital discharge (Up to 14 days).', 'description': '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).', 'description': '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).', 'description': 'Needing of dyalisis in peoperative period'}, {'measure': 'Perioperative infection', 'timeFrame': 'Until perioperative day 3', 'description': 'Anytype'}, {'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).', 'description': 'Thorax drain tubes bleeding (ml)'}, {'measure': 'Epigenetics alterations', 'timeFrame': 'Until perioperative day 3', 'description': '. 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.'}, {'measure': 'Inflammatory response', 'timeFrame': 'Until perioperative day 3', 'description': '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.'}, {'measure': 'Perioperative myocardial infarction', 'timeFrame': 'Until perioperative day 3', 'description': 'According to type 5 Myocardial ischemia'}, {'measure': 'Stroke', 'timeFrame': 'Until perioperative day 3', 'description': 'Any level of neurological deficit'}, {'measure': 'Hemoglobin levels', 'timeFrame': 'Until perioperative day 3 and at discharge', 'description': 'Accountable in g/dl'}, {'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).', 'description': '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).)', 'description': 'any cardiovascular reason as main cause of death accountable as in-hospital mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia', 'Coronary Disease', 'Coronary Artery Disease', 'Coronary Stenosis', 'Coronary Occlusion', 'Systemic Inflammatory Response', 'Bleeding', 'Epigenetic Disorder']}, 'referencesModule': {'references': [{'pmid': '16684074', 'type': 'BACKGROUND', 'citation': 'Alghamdi AA, Albanna MJ, Guru V, Brister SJ. 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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': '12400765', 'type': 'BACKGROUND', 'citation': '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': '23590915', 'type': 'BACKGROUND', 'citation': 'Farmer SL, Towler SC, Leahy MF, Hofmann A. Drivers for change: Western Australia Patient Blood Management Program (WA PBMP), World Health Assembly (WHA) and Advisory Committee on Blood Safety and Availability (ACBSA). 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Layer-specific strain for assessing the effect of naringin on systolic myocardial dysfunction induced by sepsis and its underlying mechanisms. J Int Med Res. 2021 Jan;49(1):300060520986369. doi: 10.1177/0300060520986369.'}, {'pmid': '24263581', 'type': 'BACKGROUND', 'citation': 'Wademan BH, Galvin SD. Desmopressin for reducing postoperative blood loss and transfusion requirements following cardiac surgery in adults. Interact Cardiovasc Thorac Surg. 2014 Mar;18(3):360-70. doi: 10.1093/icvts/ivt491. Epub 2013 Nov 21.'}, {'pmid': '34559371', 'type': 'BACKGROUND', 'citation': 'Yang SS, Al Kharusi L, Gosselin A, Chirico A, Baradari PG, Cameron MJ. Iron supplementation for patients undergoing cardiac surgery: a systematic review and meta-analysis of randomized controlled trials. Can J Anaesth. 2022 Jan;69(1):129-139. doi: 10.1007/s12630-021-02113-z. Epub 2021 Sep 24.'}, {'pmid': '24644377', 'type': 'BACKGROUND', 'citation': 'Ziabakhsh-Tabary S, Jalalian R, Mokhtari-Esbuie F, Habibi MR. Echocardiographic Evaluation of the Effects of a Single Bolus of Erythropoietin on Reducing Ischemia-Reperfusion Injuries during Coronary Artery Bypass Graft Surgery; A Randomized, Double-Blind, Placebo-Control Study. Iran J Med Sci. 2014 Mar;39(2):94-101.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eletive surgery;\n* Only CABG as procedure;\n* Off pump CABG candidate.\n\nExclusion Criteria:\n\n* Age \\> 80 years;\n* Chronic dialytic kidney disease;\n* Chronic rheumatologic disease;\n* Men with Hb levels \\> 13 g/dl and \\< 8g/dl;\n* Women with Hb levels \\> 12 g/dl and \\< 8g/dl;\n* Presence of another heart disease requiring surgical intervention;\n* Presence of hepatic insufficiency;\n* Presence of any implantable electronic cardiac device in any cardiac chambers;\n* Pregnancy;\n* Diagnosis of malignant neoplasia;\n* Thrombophilias;\n* Need for Erythropoietin treatment due to any other disease.\n* Recent ischemic event (\\< 3 months).\n* Ejection fraction \\<30%.'}, 'identificationModule': {'nctId': 'NCT06542393', 'briefTitle': 'PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG)', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Patient Blood Manegement (PBM) as Perioperative Strategy to Anemic Patients Who Will be Submitted to Coronary Artery Bypass Graft (CABG).', 'orgStudyIdInfo': {'id': '0009/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Randomized Anemia Group for non-PBM protocol (GNPBM)', 'description': 'Patients \\> 18 years admitted to Hospital São Paulo for Coronary Artery Bypass Grafting (CABG) surgery who are hospitalized in the Cardiovascular Surgery department or another specialty unit and are anemic (Hemoglobin - Hb \\< 12g/dl in women and \\< 13g/dl in men)', 'interventionNames': ['Procedure: blood transfusion']}, {'type': 'EXPERIMENTAL', 'label': 'Randomized Anemia Group for PBM protocol (GPBM)', 'description': 'Patients \\>18 years admitted to Hospital São Paulo for Coronary Artery Bypass Grafting (CABG) surgery who are hospitalized in the Cardiovascular Surgery department or another specialty unit and are anemic (Hb \\< 12g/dl in women and \\< 13g/dl in men)', 'interventionNames': ['Drug: Erythropoietin']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group (GC)', 'description': 'Patients \\> 18 years admitted to Hospital SãoPaulo for Coronary Artery Bypass Grafting (CABG) surgery who arehospitalized in the Cardiovascular Surgery department or another specialty unit and do not have anemia (Hb \\> 13g/dl in men and \\> 12g/dl in women)'}], 'interventions': [{'name': 'Erythropoietin', 'type': 'DRUG', 'description': '* 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).\n* 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.', 'armGroupLabels': ['Randomized Anemia Group for PBM protocol (GPBM)']}, {'name': 'blood transfusion', 'type': 'PROCEDURE', 'description': 'After surgery, this group will receive one unit of RBC at the moment of ICU admission.\n\nHb \\> 8 g/dl: 1 unit of RBC. HB \\< 8 g/dl: 2 units of RBC.', 'armGroupLabels': ['Randomized Anemia Group for non-PBM protocol (GNPBM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04024-002', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'ISABEL CESPEDES, PhD', 'role': 'CONTACT', 'email': 'isabel.cespedes@unifesp.br', 'phone': '05511996895763'}, {'name': 'LEONARDO OHASHI, MD', 'role': 'CONTACT', 'email': 'leonardo.ohashi@unifesp.br', 'phone': '05511970531919'}], 'facility': 'Leonardo Ohashi', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'LEONARDO OHASHI', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}