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Completed

NCT Number: NCT06553833

Outcomes of Patient Blood Management in Patients Undergoing Major Surgery

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.

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Key information

Conditions

Major Surgery Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helios Klinikum

Gotha, 99867, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allogeneic transfusion

Biological

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

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).

Primary outcomes

  1. Inhospital Mortality

    Time frame: 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 dead participants at the end of hospitalization (inhospital mortality)

Secondary outcomes

  1. Local surgical complications

    Time frame: 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

    Number of participants with local surgical complications

  2. Acute myocardial infarction

    Time frame: 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 acute myocardial infarction

  3. Renal injury

    Time frame: 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 renal injury (according to RIFLE criteria)

  4. Length of stay in hospital

    Time frame: 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

    Number of days a participant spends in hospital

  5. Readmission

    Time frame: From date of admission to hospital until 30 days thereafter

    Number of participants readmitted to the same hospital within 30 days from first admission

  6. Transfusion reaction

    Time frame: 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 transfusion reaction

  7. Need of Intensive Care Unit treatment

    Time frame: 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 needing treatment in an Intensive Care Unit

  8. Respiratory complications

    Time frame: 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 respiratory complications, defined as those needing ventilatory assistance

Sponsors and collaborators

Lead sponsor

Helios Klinik Gotha/Ohrdruf

Other

Collaborators

  • HELIOS Hospital, Erfurt, Germany
  • Matthias Lucas

Registry information

Official study title

Impact of Transfusions and Patient Blood Management on Outcomes in Patients Undergoing Major Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2024
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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