Outcomes of Patient Blood Management in Severely Anemic Patients

NCT06345417 | Not Yet Recruiting

• 1 other identifier: O-PBM1
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Severe Anemia

Keywords

patient blood management; blood transfusion

Outcome Measures

Primary Outcomes (1)

• Number of dead participants at the end of hospitalization (inhospital mortality)

  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 Outcomes (9)

• Number of participants with surgical wound complications

  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

  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

  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)

  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

  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

Study Arms (3)

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.

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.

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.

Biological: Allogeneic transfusion

Interventions

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.

PBM only; PBM with transfusion

Allogeneic transfusion BIOLOGICAL

Anemia is treated by administering donor red cells, and bleeding or coagulopathy by plasma, platelets or other donor blood products.

PBM with transfusion; Transfusion only

Eligibility Criteria

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

Study Population

all hospitalized participants admitted to Helios Klinikum Gotha and Erfurt between 2008 and 2020

You may qualify if:

• adult
• nadir hemoglobin \< 8 g/dL

You may not qualify if:

• treatment in a non-comparable specialty
• transfer from hospital in the first 6 h after arrival
• requesting PBM / transfusion-free therapy but not offered

Sponsors & Collaborators

• Helios Klinik Gotha/Ohrdruf: lead
• HELIOS Hospital, Erfurt, Germany: collaborator

Study Sites (2)

Helios Klinikum

Erfurt, Thuringia, Germany

Location

Helios Klinikum

Gotha, Thuringia, 99867, Germany

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Petra Seeber

  HELIOS Klinikum Gotha

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Seeber

CONTACT

+49-3621-2200; petra.seeber@helios-gesundheit.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: February 28, 2024
• First Posted: April 3, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)