Severe AnemiaNCT06345469
Cost Analysis of Therapies for Severe Anemia
An observational study of Severe Anemia, run by Helios Klinik Gotha/Ohrdruf.
Trial summary
The goal of this observational study is to learn about the costs that occur when participants with severe anemia are treated with blood transfusions or with patient blood management (PBM). 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
- 640 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 May 2026
- 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: Participants admitted to Helios Klinikum Gotha, Germany, between 2008 and 2020
Who may be able to join
- adult (> 18 years at admission)
- hemoglobin nadir of < 8 g/dL
Who cannot join
- participants treated by physicians not related to Helios Klinikum Gotha
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cost Effectiveness Analysis of Transfusion Therapy and Patient Blood Management in Patients With Severe Anemia
The goal of this observational study is to learn about the costs that occur when participants with severe anemia are treated with blood transfusions or with patient blood management (PBM). PBM means that the body of the participant is stimulated to produce new blood by itself rather than receiving it from a blood donor, and to reduce blood losses.
The main question the study aims to answer is: Do participants treated with transfusions incur the same treatment costs than participants treated with PBM? And how much costs are this in relation to the lives saved by the therapy of severe anemia?
Read the detailed description
Background:
Severe anemia is a condition that is associated with increased morbidity and mortality in hospitalized patients. In an effort to treat severe anemia, transfusions and/or Patient Blood Management are provided with the goal to reduce morbidity and mortality. This treatment naturally incurs costs. Several studies already tried to evaluate the costs of transfusions and PBM and to compare them. However, a comparison of the therapy costs of severe anemia and their cost effectiveness is not available.
Objective: It is the objective of this study to assess therapeutic costs of severe anemia and to compare the cost effectiveness of transfusion therapy and PBM in relation to their effect on inhospital mortality.
Hypothesis: It is hypothesized that the therapy of severely anemic participants who received PBM and who receive transfusions is equally cost effective as regards its ability to reduce in-hospital mortality.
Setting: The study will be performed at HELIOS Klinikum Gotha, a hospital with general, advanced and specialized care which offers not only transfusions but also PBM.
Data sources: Data will be sourced from the hospital information system as well as from chart review.
Participants: All adult patients treated between 2008 and 2020 in Helios Klinikum Gotha who had a nadir hemoglobin of less than 8 g/dL and who opted to be treated with PBM, but not with allogeneic transfusions. A control group will be matched from all other severely anemic patients treated in the same time period but who opted to receive transfusions.
Interventions: allogeneic transfusion therapy with red blood cells according to the standards of the Federal Chamber of Physicians in Germany or Patient Blood Management only without transfusion of allogeneic red cells.
Outcome:
The primary outcome is the cost-effectiveness of transfusion therapy and PBM to reduce in-hospital mortality.
Costs will be calculated by the top-down and the bottom-up method and the Incremental Cost Effectiveness Ratio (ICER) will be calculated in relation to mortality reduction.
Study design:
This is a retrospective observational cohort study. Reporting of the results will be performed in line with the CHEERS (Consolidated Health Economic Evaluation Reporting Standards 2022) 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
- anemia, costs, transfusion, patient blood management
- 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 means the medical enhancement of the participants own hematopoietic reserve to treat anemia and to reduce the ill effects of disease and bleeding on hematopoiesis and homeostasis.
Allogeneic transfusionBiological
transfusion of donor red cells
| Study group | Role | What they receive |
|---|---|---|
| PBM only | The Study group received comprehensive Patient Blood Management without allogeneic transfusions to treat their severe anemia. Receives: Other: Patient blood management (PBM) | |
| PBM with transfusion | The Control group opted to be treated with allogeneic transfusions together with convenience measures of PBM. Receives: Other: Patient blood management (PBM); Biological: Allogeneic transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost-effectiveness
The study evaluates costs incurred to treat severe anemia and how these relates to its effect on reduction of inhospital mortality.
Measured: From date of admission to hospital until the date of discharge 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 2026 (estimated)
- Study completion1 May 2026 (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
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helios Klinik Gotha/Ohrdruf
- Sponsor type
- University, hospital or other
- Collaborators
- Marisa Eichner
- Responsible party
- Principal investigator, Petra Seeber, Helios Klinik Gotha/Ohrdruf
- Investigators
- Petra Seeber, MD, Principal investigator, HELIOS Klinikum Gotha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345469
- Sponsor's protocol ID
- O-PBM2
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 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
- Cost Effectiveness Analysis of Transfusion Therapy and Patient Blood Management in Patients With Severe Anemia
- ClinicalTrials.gov ID
- NCT06345469
- Acronym / sponsor ID
- O-PBM2
- Conditions
- Severe Anemia
- Keywords
- anemia, costs, transfusion, patient blood management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Helios Klinik Gotha/OhrdrufUniversity, hospital or other
- Collaborators
- Marisa Eichner
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (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 study is to learn about the costs that occur when participants with severe anemia are treated with blood transfusions or with patient blood management (PBM). PBM means that the body of the participant is stimulated to produce new blood by itself rather than receiving it from a blood donor, and to reduce blood losses.
The main question the study aims to answer is: Do participants treated with transfusions incur the same treatment costs than participants treated with PBM? And how much costs are this in relation to the lives saved by the therapy of severe anemia?
Detailed description
Background:
Severe anemia is a condition that is associated with increased morbidity and mortality in hospitalized patients. In an effort to treat severe anemia, transfusions and/or Patient Blood Management are provided with the goal to reduce morbidity and mortality. This treatment naturally incurs costs. Several studies already tried to evaluate the costs of transfusions and PBM and to compare them. However, a comparison of the therapy costs of severe anemia and their cost effectiveness is not available.
Objective: It is the objective of this study to assess therapeutic costs of severe anemia and to compare the cost effectiveness of transfusion therapy and PBM in relation to their effect on inhospital mortality.
Hypothesis: It is hypothesized that the therapy of severely anemic participants who received PBM and who receive transfusions is equally cost effective as regards its ability to reduce in-hospital mortality.
Setting: The study will be performed at HELIOS Klinikum Gotha, a hospital with general, advanced and specialized care which offers not only transfusions but also PBM.
Data sources: Data will be sourced from the hospital information system as well as from chart review.
Participants: All adult patients treated between 2008 and 2020 in Helios Klinikum Gotha who had a nadir hemoglobin of less than 8 g/dL and who opted to be treated with PBM, but not with allogeneic transfusions. A control group will be matched from all other severely anemic patients treated in the same time period but who opted to receive transfusions.
Interventions: allogeneic transfusion therapy with red blood cells according to the standards of the Federal Chamber of Physicians in Germany or Patient Blood Management only without transfusion of allogeneic red cells.
Outcome:
The primary outcome is the cost-effectiveness of transfusion therapy and PBM to reduce in-hospital mortality.
Costs will be calculated by the top-down and the bottom-up method and the Incremental Cost Effectiveness Ratio (ICER) will be calculated in relation to mortality reduction.
Study design:
This is a retrospective observational cohort study. Reporting of the results will be performed in line with the CHEERS (Consolidated Health Economic Evaluation Reporting Standards 2022) 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
- 2
| Arm | Type | Receives |
|---|---|---|
| PBM only | – | Other: Patient blood management (PBM)The Study group received comprehensive Patient Blood Management without allogeneic transfusions to treat their severe anemia. |
| PBM with transfusion | – | Other: Patient blood management (PBM), Biological: Allogeneic transfusionThe Control group opted to be treated with allogeneic transfusions together with convenience measures of PBM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants admitted to Helios Klinikum Gotha, Germany, between 2008 and 2020
Key inclusion criteria (2 listed)
- adult (> 18 years at admission)
- hemoglobin nadir of < 8 g/dL
Key exclusion criteria (1 listed)
- participants treated by physicians not related to Helios Klinikum Gotha
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 means the medical enhancement of the participants own hematopoietic reserve to treat anemia and to reduce the ill effects of disease and bleeding on hematopoiesis and homeostasis. | Other | PBM only, PBM with transfusion |
| Allogeneic transfusiontransfusion of donor red cells | Biological | PBM with transfusion |
Primary outcome
cost-effectiveness
Time frame: From date of admission to hospital until the date of discharge or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
The study evaluates costs incurred to treat severe anemia and how these relates to its effect on reduction of inhospital mortality.
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
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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, MD principal investigator
HELIOS Klinikum Gotha
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Anemia, run by Helios Klinik Gotha/Ohrdruf.
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 1 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.
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 Marisa Eichner (+49-17672731730, marisaeichner@web.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cost-effectiveness (time frame: From date of admission to hospital until the date of discharge 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.