Severe AnemiaNCT06345417
Outcomes of Patient Blood Management in Severely Anemic Patients
An observational study of Severe Anemia, run by Helios Klinik Gotha/Ohrdruf at 2 sites in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Anemia
- What is being tested?
- Patient Blood Management (PBM) and Allogeneic transfusion
- How many people
- 20,000 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Apr 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all hospitalized participants admitted to Helios Klinikum Gotha and Erfurt between 2008 and 2020
Who may be able to join
- adult
- nadir hemoglobin < 8 g/dL
Who cannot join
- treatment in a non-comparable specialty
- transfer from hospital in the first 6 h after arrival
- requesting PBM / transfusion-free therapy but not offered
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Helios Klinikum
Erfurt, Thuringia
Achim Spenner, +49-361-7810, Achim.Spenner@helios-gesundheit.de
Helios Klinikum
Gotha, Thuringia, 99867
Petra See, +49-3621-220 0, petra.seeber@helios-gesundheit.de
Kai D, +49-3621-220 ext. 5058, Kai-uwe.doebel@helios-gesundheit.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Severe Anemia
- Being tested
- Patient Blood Management (PBM), Allogeneic transfusion
- Keywords
- patient blood management, blood transfusion
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Blood Management (PBM)Other
PBM is a strategy to manage the participant's own blood. Its focus is on anemia, bleeding and coagulation management.
Allogeneic transfusionBiological
Anemia is treated by administering donor red cells, and bleeding or coagulopathy by plasma, platelets or other donor blood products.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient Blood Management (PBM) | |
| 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. Receives: Other: Patient Blood Management (PBM); Biological: Allogeneic transfusion | |
| Transfusion only | The control group is treated in an environment where PBM is not implemented and transfusion is the standard therapy for severe anemia. Receives: Biological: Allogeneic transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dead participants at the end of hospitalization (inhospital mortality)
Death at discharge from hospital
Measured: 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 outcomes (9)
Number of participants with surgical wound complications
Number of participants with a documented presence of surgical wound complications (according to pre-specified ICD list)
Measured: 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
Acute myocardial infarction (as documented by increase in troponin in conjunction with AMI diagnose)
Measured: 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
Renal injury (according to RIFLE criteria)
Measured: 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)
Length of stay in hospital, calculated in days
Measured: 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
Readmission within 30 days
Measured: 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
Transfusion reactions (according to ICD codes T80.3 and T80.4)
Measured: 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
Transfusion rates per admission, calculated for red blood cells, platelets, plasma
Measured: 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
Indicator whether or not the participant was treated in an intensive care unit
Measured: 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
Respiratory complications as documented by ventilation support rate (per admission)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helios Klinik Gotha/Ohrdruf
- Sponsor type
- University, hospital or other
- Collaborators
- HELIOS Hospital, Erfurt, Germany
- Responsible party
- Principal investigator, Petra Seeber, Helios Klinik Gotha/Ohrdruf
- Investigators
- Petra Seeber, Principal investigator, HELIOS Klinikum Gotha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345417
- Sponsor's protocol ID
- O-PBM1
- Status last verified
- Apr 2024
- First submitted
- 28 Feb 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transfusions and Patient Blood Management on Morbidity and Mortality in Severe Anemia
- ClinicalTrials.gov ID
- NCT06345417
- Acronym / sponsor ID
- O-PBM1
- Conditions
- Severe Anemia
- Keywords
- patient blood management, blood transfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Helios Klinik Gotha/OhrdrufUniversity, hospital or other
- Collaborators
- HELIOS Hospital, Erfurt, Germany
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PBM only | – | Other: Patient Blood Management (PBM)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 with transfusion | – | Other: Patient Blood Management (PBM), Biological: Allogeneic transfusionParticipants 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. |
| Transfusion only | – | Biological: Allogeneic transfusionThe control group is treated in an environment where PBM is not implemented and transfusion is the standard therapy for severe anemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all hospitalized participants admitted to Helios Klinikum Gotha and Erfurt between 2008 and 2020
Key inclusion criteria (2 listed)
- adult
- nadir hemoglobin < 8 g/dL
Key exclusion criteria (3 listed)
- treatment in a non-comparable specialty
- transfer from hospital in the first 6 h after arrival
- requesting PBM / transfusion-free therapy but not offered
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Blood Management (PBM)PBM is a strategy to manage the participant's own blood. Its focus is on anemia, bleeding and coagulation management. | Other | PBM only, PBM with transfusion |
| Allogeneic transfusionAnemia is treated by administering donor red cells, and bleeding or coagulopathy by plasma, platelets or other donor blood products. | Biological | PBM with transfusion, Transfusion only |
Primary outcome
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
9 secondary outcomes
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 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
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Severe Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 2
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
Severe Aplastic Anemia, MDS (Myelodysplastic Syndrome)
RecruitingPhase 1/2
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Dibotatug (DR-01) in Adults With Bone Marrow Failure Syndromes
Bone Marrow Failure Syndromes, Aplastic Anemias
Active, not recruitingPhase 2
Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia
Aplastic Anemia, TPO Receptor Agonists
RecruitingObservational study
Natural History of Acquired and Inherited Bone Marrow Failure Syndromes
Severe Aplastic Anemia, Telomere Biology Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Seeber principal investigator
HELIOS Klinikum Gotha
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Anemia, run by Helios Klinik Gotha/Ohrdruf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petra Seeber (+49-3621-2200, petra.seeber@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.