Clinical trial NCT06553833: Outcomes of Patient Blood Management in Patients Undergoing Major Surgery
Official title: Impact of Transfusions and Patient Blood Management on Outcomes in Patients Undergoing Major Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Surgery
Keywords: major surgery
anemia
transfusion
patient blood management
Lead sponsor: Helios Klinik Gotha/Ohrdruf
Sponsor class: OTHER
Collaborators: name: HELIOS Hospital, Erfurt, Germany
name: Matthias Lucas
First posted: 2024-08-14
Enrollment: 25979
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Detailed description: Background:

There seems to be a clear relationship between hemoglobin level and inhospital morbidity and mortality. To mitigate negative effects of lower hemoglobin levels, that is, anemia, transfusions are given when the hemoglobin level of the patient reaches a point deemed detrimental by the treating health care personnel. Patient Blood Management (PBM) adds to the armamentarium of anemia therapy, starting typically well before transfusions are given, and sometimes beyond this point. PBM utilizes medical strategies to enhance the patients own red cell mass and to alleviate the ill effects of disease and bleeding on hematopoiesis and hemostasis.

Objective:

The objectives of this study is to investigate the effects of different blood management strategies in patients undergoing major surgery, namely PBM exclusively or PBM with transfusion therapy combined, and compare them to standard transfusion therapy as regards inhospital mortality and morbidity.

Hypothesis:

It is hypothesized that participants who undergo major surgery and who were eligible to receive a combination of PBM and restrictive transfusion regime would have a lower mortality and less complications than participants receiving a liberal transfusion therapy without PBM, while participants opting to receive only PBM without transfusion support will have increased inhospital mortality and morbidity.

Setting:

The study will be performed at HELIOS Klinikum Gotha (HKG) and HELIOS Klinikum Erfurt (HKE) which are two neighboring hospitals with overlapping personnel, purchasing, IT departments and standard operating procedures. Both hospitals offer basic, advanced and specialist care to their communities. HKG offers PBM to their patients, while HKE does not.

Data sources:

Data will be sourced from the hospital information systems of HKG and HKE. Diseases are coded with the ICD-10-GM (International Code of Diseases, Version 10, Germany) and procedures using the OPS code (Procedure Key, analogous to the International Code of Procedures).

Participants:

All adults undergoing major surgery and being treated between June 01, 2008 and December 31, 2020 in HKG and HKE will be eligible for enrollment when they were treated by a specialty that both hospitals offer.

Interventions:

Study group 1: Participants in this group received full PBM measures as clinically appropriate, but were not transfused at all, no matter how low their hemoglobin dropped.

Study group 2:

Participants in this group received convenience measures of PBM and were transfused as deemed necessary in an environment where a restrictive transfusion strategy is encouraged.

Control:

The control group was treated without systematic PBM offered to patients and transfusions were the only standard of care beyond the individual transfusion trigger.

Outcome:

Primary outcome is inhospital mortality. Secondary outcomes are morbidity measures as outlined below.

Study design:

This is a dual-center, retrospective observational cohort study. Reporting of results will be performed in line with the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement extension of the STrengthening the Reporting of Observational studies in Epidemiology (STROBE) statement.

Eligibility criteria: Inclusion Criteria:

* adult
* undergoing major surgery

Exclusion Criteria:

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

Primary outcomes:
measure: Inhospital Mortality
timeFrame: 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:
measure: Local surgical complications
timeFrame: 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
measure: Acute myocardial infarction
timeFrame: 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
measure: Renal injury
timeFrame: 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
measure: Length of stay in hospital
timeFrame: 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
measure: Readmission
timeFrame: From date of admission to hospital until 30 days thereafter
measure: Transfusion reaction
timeFrame: 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
measure: Need of Intensive Care Unit treatment
timeFrame: 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
measure: Respiratory complications
timeFrame: 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
Other outcomes:
Locations:
city: Gotha
country: Germany
facility: Helios Klinikum
Study officials:
affiliation: HELIOS Klinikum Gotha
name: Petra Seeber
role: PRINCIPAL_INVESTIGATOR
References: