Cost Analysis of Therapies for Severe Anemia

NCT06345469 | Not Yet Recruiting

• 1 other identifier: O-PBM2
• Study Type: observational
• Target: 640
• Locations: 0 countries
• Sites: N/A

Brief 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?

Conditions

Severe Anemia

Keywords

anemia; costs; transfusion; patient blood management

Outcome Measures

Primary Outcomes (1)

• cost-effectiveness

  The study evaluates costs incurred to treat severe anemia and how these relates to its effect on reduction of inhospital mortality.

  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

Study Arms (2)

PBM only

The Study group received comprehensive Patient Blood Management without allogeneic transfusions to treat their severe anemia.

Other: Patient blood management (PBM)

PBM with transfusion

The Control group opted to be treated with allogeneic transfusions together with convenience measures of PBM.

Other: Patient blood management (PBM); Biological: Allogeneic transfusion

Interventions

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.

PBM only; PBM with transfusion

Allogeneic transfusion BIOLOGICAL

transfusion of donor red cells

PBM with transfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants admitted to Helios Klinikum Gotha, Germany, between 2008 and 2020

You may qualify if:

• adult (\> 18 years at admission)
• hemoglobin nadir of \< 8 g/dL

You may not qualify if:

• participants treated by physicians not related to Helios Klinikum Gotha

Sponsors & Collaborators

• Helios Klinik Gotha/Ohrdruf: lead
• Marisa Eichner: collaborator

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Petra Seeber, MD

  HELIOS Klinikum Gotha

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marisa Eichner

CONTACT

+49-17672731730; marisaeichner@web.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 3, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share