Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345417
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-02-28
Brief Title:
Outcomes of Patient Blood Management in Severely Anemic Patients
Sponsor:
Helios Klinik GothaOhrdruf
Organization:
Helios Klinik GothaOhrdruf
Study Overview
Official Title:
Impact of Transfusions and Patient Blood Management on Morbidity and Mortality in Severe Anemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational cohort study is to compare patients with very low red blood counts who receive different therapy Its main questions it aims to answer are
Which group of patients dies more frequent Patients who receive patient blood management only patients who receive patient blood management and transfusions or patients who receive only transfusions
Among these groups which group of patients has more complications during hospital stay Patients will either receive patient 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 frequent Patients who receive patient blood management only patients who receive patient blood management and transfusions or patients who receive only transfusions
Among these groups which group of patients has more complications during hospital stay Patients will either receive patient 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 hematopoesis and homeostasis
Objective
The objectives of the present study is to investigate the effects of 2 different management strategies of severe anemia namely PBM exclusively or PBM with transfusion therapy and compare them to standard transfusion therapy as regards inhospital mortality and morbidity
Hypothesis It is hypothesized that severely anemic participants who received 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 not being transfused at all will have increased 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 adult patients treated between 162008 and 31122020 in HKG and HKE will be eligible for enrollment when they were treated by a specialty that both hospitals offer and suffer from severe anemia defined as a nadir hemoglobin of 8 gdL
Interventions
Study group 1 Participants in this group received full PBM measures as clinically appropriate but were not transfused at all
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 for severely anemic patients
Outcome
Primary outcome is inhospital mortality Secondary outcomes are morbidity measures such as acute myocardial infarction blood stream infection cerebrovascular accident transfusion complications readmission rates etc
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
The study will be guided by a study protocol with an attached statistical analysis plan
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 hematopoesis and homeostasis
Objective
The objectives of the present study is to investigate the effects of 2 different management strategies of severe anemia namely PBM exclusively or PBM with transfusion therapy and compare them to standard transfusion therapy as regards inhospital mortality and morbidity
Hypothesis It is hypothesized that severely anemic participants who received 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 not being transfused at all will have increased 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 adult patients treated between 162008 and 31122020 in HKG and HKE will be eligible for enrollment when they were treated by a specialty that both hospitals offer and suffer from severe anemia defined as a nadir hemoglobin of 8 gdL
Interventions
Study group 1 Participants in this group received full PBM measures as clinically appropriate but were not transfused at all
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 for severely anemic patients
Outcome
Primary outcome is inhospital mortality Secondary outcomes are morbidity measures such as acute myocardial infarction blood stream infection cerebrovascular accident transfusion complications readmission rates etc
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
The study will be guided by a study protocol with an attached statistical analysis plan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None