Outcomes of Patient Blood Management in Patients Undergoing Major Surgery
NCT Number: NCT06553833
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Major Surgery
Interventions: BIOLOGICAL: Allogeneic transfusion|OTHER: Patient Blood Management
Sponsor: Helios Klinik Gotha/Ohrdruf
Collaborators: Helios Klinikum Erfurt|Matthias Lucas
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-07-01

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.

Primary Outcome Measures: 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 Outcome Measures: Local surgical complications, Number of participants with 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, Number of participants with 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, Number of participants with renal injury (according to RIFLE criteria), 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, Number of days a participant spends 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, Number of participants readmitted to the same hospital within 30 days from first admission, From date of admission to hospital until 30 days thereafter|Transfusion reaction, Number of participants with a documented transfusion reaction, 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|Need of Intensive Care Unit treatment, Number of participants needing treatment in an Intensive Care Unit, 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|Respiratory complications, Number of participants with respiratory complications, defined as those needing ventilatory assistance, 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