Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542393
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
PBM as Strategy to CABG Anemic Patients Bypass Graft CABG
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Patient Blood Manegement PBM as Perioperative Strategy to Anemic Patients Who Will be Submitted to Coronary Artery Bypass Graft CABG
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None