Outcomes of Patient Blood Management in Patients Undergoing Major Surgery

NCT06553833 | Completed

• 1 other identifier: O-PBM3
• Study Type: observational
• Target: 25,979
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to compare patients who underwent major surgery and who were eligible to receive different management of their red blood count, namely, allogeneic transfusions with or without patient blood management, or blood management alone. Its main questions it aims to answer are: Which group of patients dies more frequently: Patients who receive patient blood management only, patients who receive patient blood management and transfusions where indicated, or patients who are eligible to receive transfusions only. Among these groups: which group of patients has more complications during hospital stay? Patients will either receive patients 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

Major Surgery

Keywords

major surgery; anemia; transfusion; patient blood management

Outcome Measures

Primary Outcomes (1)

• Inhospital Mortality

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

  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 (8)

• Local surgical complications

  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

• 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

• 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

• 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 1000 months

• Readmission

  From date of admission to hospital until 30 days thereafter

Study Arms (3)

Study group 1: PBM only

Participants in study group 1 receive full PBM while they opted not to receive transfusions.

Other: Patient Blood Management

Study group 2: PBM with transfusions

Participants in study group 2 receive partial PBM while they opted to receive transfusions. Transfusions are given by physicians encouraged to use a restrictive transfusion strategy. PBM is delivered to participants at a convenient time, resorting to a set of standard PBM measures rather than individualized care.

Biological: Allogeneic transfusion; Other: Patient Blood Management

Control group: Transfusions only

The control group is treated in an environment where PBM is not implemented and transfusion is the standard therapy for anemia, major bleeding, thrombopenia and coagulopathy beyond the transfusion trigger.

Biological: Allogeneic transfusion

Interventions

Allogeneic transfusion BIOLOGICAL

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

Control group: Transfusions only; Study group 2: PBM with transfusions

Patient Blood Management OTHER

PBM is a strategy to manage the participants own blood. Its focus is on anemia, bleeding and coagulation management (using predominantly pharmaceutical and technological means).

Study group 1: PBM only; Study group 2: PBM with transfusions

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 June 1, 2008 and December 31, 2020

You may qualify if:

• adult
• undergoing major surgery

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Helios Klinikum

Gotha, 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

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: May 5, 2024
• First Posted: August 14, 2024
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)