Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553833
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-05
Brief Title:
Outcomes of Patient Blood Management in Patients Undergoing Major Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Transfusions and Patient Blood Management on Outcomes in Patients Undergoing Major Surgery
Status:
NOT_YET_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:
The goal of this observational study is to compare patients who underwent major surgery and who were eligible to receive different management of their red blood count namely allogeneic transfusions with or without patient blood management or blood management alone Its main questions it aims to answer are
Which group of patients dies more frequently Patients who receive patient blood management only patients who receive patient blood management and transfusions where indicated or patients who are eligible to receive transfusions only
Among these groups which group of patients has more complications during hospital stay Patients will either receive patients blood management which is the management of anemia bleeding and coagulation problems will receive transfusions that is blood from other people or a mix of both
Which group of patients dies more frequently Patients who receive patient blood management only patients who receive patient blood management and transfusions where indicated or patients who are eligible to receive transfusions only
Among these groups which group of patients has more complications during hospital stay Patients will either receive patients blood management which is the management of anemia bleeding and coagulation problems will receive transfusions that is blood from other people or a mix of both
Detailed Description:
Background
There seems to be a clear relationship between hemoglobin level and inhospital morbidity and mortality To mitigate negative effects of lower hemoglobin levels that is anemia transfusions are given when the hemoglobin level of the patient reaches a point deemed detrimental by the treating health care personnel Patient Blood Management PBM adds to the armamentarium of anemia therapy starting typically well before transfusions are given and sometimes beyond this point PBM utilizes medical strategies to enhance the patients own red cell mass and to alleviate the ill effects of disease and bleeding on hematopoiesis and hemostasis
Objective
The objectives of this study is to investigate the effects of different blood management strategies in patients undergoing major surgery namely PBM exclusively or PBM with transfusion therapy combined and compare them to standard transfusion therapy as regards inhospital mortality and morbidity
Hypothesis
It is hypothesized that participants who undergo major surgery and who were eligible to receive a combination of PBM and restrictive transfusion regime would have a lower mortality and less complications than participants receiving a liberal transfusion therapy without PBM while participants opting to receive only PBM without transfusion support will have increased inhospital mortality and morbidity
Setting
The study will be performed at HELIOS Klinikum Gotha HKG and HELIOS Klinikum Erfurt HKE which are two neighboring hospitals with overlapping personnel purchasing IT departments and standard operating procedures Both hospitals offer basic advanced and specialist care to their communities HKG offers PBM to their patients while HKE does not
Data sources
Data will be sourced from the hospital information systems of HKG and HKE Diseases are coded with the ICD-10-GM International Code of Diseases Version 10 Germany and procedures using the OPS code Procedure Key analogous to the International Code of Procedures
Participants
All adults undergoing major surgery and being treated between June 01 2008 and December 31 2020 in HKG and HKE will be eligible for enrollment when they were treated by a specialty that both hospitals offer
Interventions
Study group 1 Participants in this group received full PBM measures as clinically appropriate but were not transfused at all no matter how low their hemoglobin dropped
Study group 2
Participants in this group received convenience measures of PBM and were transfused as deemed necessary in an environment where a restrictive transfusion strategy is encouraged
Control
The control group was treated without systematic PBM offered to patients and transfusions were the only standard of care beyond the individual transfusion trigger
Outcome
Primary outcome is inhospital mortality Secondary outcomes are morbidity measures as outlined below
Study design
This is a dual-center retrospective observational cohort study Reporting of results will be performed in line with the REporting of studies Conducted using Observational Routinely-collected health Data RECORD statement extension of the STrengthening the Reporting of Observational studies in Epidemiology STROBE statement
There seems to be a clear relationship between hemoglobin level and inhospital morbidity and mortality To mitigate negative effects of lower hemoglobin levels that is anemia transfusions are given when the hemoglobin level of the patient reaches a point deemed detrimental by the treating health care personnel Patient Blood Management PBM adds to the armamentarium of anemia therapy starting typically well before transfusions are given and sometimes beyond this point PBM utilizes medical strategies to enhance the patients own red cell mass and to alleviate the ill effects of disease and bleeding on hematopoiesis and hemostasis
Objective
The objectives of this study is to investigate the effects of different blood management strategies in patients undergoing major surgery namely PBM exclusively or PBM with transfusion therapy combined and compare them to standard transfusion therapy as regards inhospital mortality and morbidity
Hypothesis
It is hypothesized that participants who undergo major surgery and who were eligible to receive a combination of PBM and restrictive transfusion regime would have a lower mortality and less complications than participants receiving a liberal transfusion therapy without PBM while participants opting to receive only PBM without transfusion support will have increased inhospital mortality and morbidity
Setting
The study will be performed at HELIOS Klinikum Gotha HKG and HELIOS Klinikum Erfurt HKE which are two neighboring hospitals with overlapping personnel purchasing IT departments and standard operating procedures Both hospitals offer basic advanced and specialist care to their communities HKG offers PBM to their patients while HKE does not
Data sources
Data will be sourced from the hospital information systems of HKG and HKE Diseases are coded with the ICD-10-GM International Code of Diseases Version 10 Germany and procedures using the OPS code Procedure Key analogous to the International Code of Procedures
Participants
All adults undergoing major surgery and being treated between June 01 2008 and December 31 2020 in HKG and HKE will be eligible for enrollment when they were treated by a specialty that both hospitals offer
Interventions
Study group 1 Participants in this group received full PBM measures as clinically appropriate but were not transfused at all no matter how low their hemoglobin dropped
Study group 2
Participants in this group received convenience measures of PBM and were transfused as deemed necessary in an environment where a restrictive transfusion strategy is encouraged
Control
The control group was treated without systematic PBM offered to patients and transfusions were the only standard of care beyond the individual transfusion trigger
Outcome
Primary outcome is inhospital mortality Secondary outcomes are morbidity measures as outlined below
Study design
This is a dual-center retrospective observational cohort study Reporting of results will be performed in line with the REporting of studies Conducted using Observational Routinely-collected health Data RECORD statement extension of the STrengthening the Reporting of Observational studies in Epidemiology STROBE statement
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