Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06345469 |
| Other study ID # |
O-PBM2 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2024 |
| Est. completion date |
May 1, 2026 |
Study information
| Verified date |
April 2024 |
| Source |
Helios Klinik Gotha/Ohrdruf |
| Contact |
Marisa Eichner |
| Phone |
+49-17672731730 |
| Email |
marisaeichner[@]web.de |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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). 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?
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.
