- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06345417
Outcomes of Patient Blood Management in Severely Anemic Patients
Impact of Transfusions and Patient Blood Management on Morbidity and Mortality in Severe Anemia
The goal of this observational cohort study is to compare patients with very low red blood counts who receive different therapy. Its main question[s] 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 1.6.2008 and 31.12.2020 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 g/dL.
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Petra Seeber
- Phone Number: +49-3621-2200
- Email: petra.seeber@helios-gesundheit.de
Study Locations
-
-
Thuringia
-
Erfurt, Thuringia, Germany
- Helios Klinikum
-
Contact:
- Achim Spenner
- Phone Number: +49-361-7810
- Email: Achim.Spenner@helios-gesundheit.de
-
Gotha, Thuringia, Germany, 99867
- Helios Klinikum
-
Contact:
- Petra See
- Phone Number: +49-3621-220 0
- Email: petra.seeber@helios-gesundheit.de
-
Contact:
- Kai D
- Phone Number: 5058 +49-3621-220
- Email: Kai-uwe.doebel@helios-gesundheit.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult
- nadir hemoglobin < 8 g/dL
Exclusion Criteria:
- treatment in a non-comparable specialty
- transfer from hospital in the first 6 h after arrival
- requesting PBM / transfusion-free therapy but not offered
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PBM only
Participants in study group 1 receive full PBM while they opted not to receive transfusions. Full PBM included an individualized, structured approach to detection and management of anemia, bleeding and coagulopathy. PBM is provided in a timely manner. |
PBM is a strategy to manage the participant's own blood.
Its focus is on anemia, bleeding and coagulation management.
|
PBM with transfusion
Participants in the study group 2 receive partial PBM together with transfusions when deemed necessary.
Transfusions are given by physicians encouraged to use a restrictive transfusion strategy.
PBM is delivered to patients at a convenient time, resorting to a set of standard PBM measures rather than individualized care.
|
PBM is a strategy to manage the participant's own blood.
Its focus is on anemia, bleeding and coagulation management.
Anemia is treated by administering donor red cells, and bleeding or coagulopathy by plasma, platelets or other donor blood products.
|
Transfusion only
The control group is treated in an environment where PBM is not implemented and transfusion is the standard therapy for severe anemia.
|
Anemia is treated by administering donor red cells, and bleeding or coagulopathy by plasma, platelets or other donor blood products.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of dead participants at the end of hospitalization (inhospital mortality)
Time Frame: From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Death at discharge from hospital
|
From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with surgical wound complications
Time Frame: From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Number of participants with a documented presence of surgical wound complications (according to pre-specified ICD list)
|
From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Number of participants with a documented acute myocardial infarction
Time Frame: From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Acute myocardial infarction (as documented by increase in troponin in conjunction with AMI diagnose)
|
From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Number of participants suffering renal injury
Time Frame: From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Renal injury (according to RIFLE criteria)
|
From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Number of days spent in hospital (Length of stay in hospital)
Time Frame: From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Length of stay in hospital, calculated in days
|
From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Number of participants readmitted to the studied hospital
Time Frame: From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Readmission within 30 days
|
From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Number of participants with a documented transfusion reaction
Time Frame: From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Transfusion reactions (according to ICD codes T80.3 and T80.4)
|
From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Number of participants receiving an allogeneic transfusion
Time Frame: From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Transfusion rates per admission, calculated for red blood cells, platelets, plasma
|
From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Number of participants treated in an intensive care ward
Time Frame: From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Indicator whether or not the participant was treated in an intensive care unit
|
From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Number of participants with documented respiratory complications
Time Frame: From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Respiratory complications as documented by ventilation support rate (per admission)
|
From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Petra Seeber, HELIOS Klinikum Gotha
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- O-PBM1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Severe Anemia
-
University of UtahNovartisCompletedSevere Aplastic Anemia | Moderate Aplastic Anemia | Very Severe Aplastic AnemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingRecurrent Severe Aplastic Anemia | Refractory Severe Aplastic AnemiaUnited States
-
Helios Klinik Gotha/OhrdrufMarisa EichnerNot yet recruitingSevere Anemia
-
Jonathan H. WatersHbO2 Therapeutics LLCAvailableAnemia SevereUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedSevere Aplastic Anemia, Refractory | Severe Aplastic Anemia, RelapseUnited States
-
Peking University People's HospitalRecruiting
-
Boston Children's HospitalNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health... and other collaboratorsRecruitingSevere Aplastic AnemiaUnited States
-
Shanghai General Hospital, Shanghai Jiao Tong University...Ruijin Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine and other collaboratorsCompleted
-
Navy General Hospital, BeijingPeking Union Medical College Hospital; Cancer Institute and Hospital, Chinese... and other collaboratorsUnknownSevere Aplastic AnemiaChina
-
Institute of Hematology & Blood Diseases HospitalRecruiting
Clinical Trials on Patient Blood Management (PBM)
-
Helios Klinik Gotha/OhrdrufMarisa EichnerNot yet recruitingSevere Anemia
-
Prof. Serdar GunaydinRecruiting
-
Hospices Civils de LyonCompletedSevere Heart FailureFrance
-
Hospital Universitari de BellvitgeCompletedGastric Cancer | Surgery--Complications | Anemia, Iron Deficiency | Transfusion Related Complication
-
Schulthess KlinikNot yet recruitingPatient Blood Management
-
Northwestern UniversityNational Cancer Institute (NCI); Northwestern MedicineActive, not recruiting
-
University of Mississippi Medical CenterWithdrawn
-
Trakya UniversityCompletedPain | Pain Management | Fear of Pain | Patient EducationTurkey
-
Denver Health and Hospital AuthorityMicrosoft Corporation; EMC ConsultingCompletedDiabetes MellitusUnited States
-
Revmatismesykehuset ASCompleted