Major SurgeryNCT06553833
Outcomes of Patient Blood Management in Patients Undergoing Major Surgery
An observational study of Major Surgery, run by Helios Klinik Gotha/Ohrdruf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Surgery
- What is being tested?
- Allogeneic transfusion and Patient Blood Management
- How many people
- 25,979 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all hospitalized participants admitted to HELIOS Klinikum Gotha and Erfurt between June 1, 2008 and December 31, 2020
Who may be able to join
- adult
- undergoing major surgery
Who cannot join
- treatment in a non-comparable specialty
- transfer from admitting hospital within 6 h after arrival
- requesting PBM/ transfusion-free therapy but not offered
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Transfusions and Patient Blood Management on Outcomes 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.
Read the 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.
- Conditions
- Major Surgery
- Being tested
- Allogeneic transfusion, Patient Blood Management
- Keywords
- major surgery, anemia, transfusion, patient blood management
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic transfusionBiological
Anemia is treated by administering donor red cells, and bleeding or coagulopathy by plasma, platelets or other donor blood products.
Patient Blood ManagementOther
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 | Role | What they receive |
|---|---|---|
| Study group 1: PBM only | Participants in study group 1 receive full PBM while they opted not to receive transfusions. Receives: 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. Receives: 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. Receives: Biological: Allogeneic transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhospital Mortality
Number of dead participants at the end of hospitalization (inhospital mortality)
Measured: 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
Number of participants with local surgical complications
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: From date of admission to hospital until 30 days thereafter
Transfusion reaction
Number of participants with a documented transfusion reaction
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Sep 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25,979 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios Klinik Gotha/Ohrdruf
- Sponsor type
- University, hospital or other
- Collaborators
- HELIOS Hospital, Erfurt, Germany, Matthias Lucas
- Responsible party
- Principal investigator, Petra Seeber, Helios Klinik Gotha/Ohrdruf
- Investigators
- Petra Seeber, Principal investigator, HELIOS Klinikum Gotha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553833
- Sponsor's protocol ID
- O-PBM3
- Status last verified
- Apr 2025
- First submitted
- 5 May 2024
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lucas M, Stoll R, Dobel KU, Spenner A, Trentino KM, Murray K, Seeber P. Outcomes of Nontransfusable and Transfusable Patients After Major Noncardiac Surgery: A Retrospective Cohort Study. Anesth Analg. 2026 Apr 1;142(4):653-663. doi: 10.1213/ANE.0000000000007718. Epub 2025 Aug 29.
PubMed 40880263
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transfusions and Patient Blood Management on Outcomes in Patients Undergoing Major Surgery
- ClinicalTrials.gov ID
- NCT06553833
- Acronym / sponsor ID
- O-PBM3
- Conditions
- Major Surgery
- Keywords
- major surgery, anemia, transfusion, patient blood management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,979 participants (actual)
- Lead sponsor
- Helios Klinik Gotha/OhrdrufUniversity, hospital or other
- Collaborators
- HELIOS Hospital, Erfurt, Germany, Matthias Lucas
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group 1: PBM only | – | Other: Patient Blood ManagementParticipants in study group 1 receive full PBM while they opted not to receive transfusions. |
| Study group 2: PBM with transfusions | – | Biological: Allogeneic transfusion, Other: Patient Blood ManagementParticipants 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. |
| Control group: Transfusions only | – | Biological: Allogeneic transfusionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all hospitalized participants admitted to HELIOS Klinikum Gotha and Erfurt between June 1, 2008 and December 31, 2020
Key inclusion criteria (2 listed)
- adult
- undergoing major surgery
Key exclusion criteria (3 listed)
- treatment in a non-comparable specialty
- transfer from admitting hospital within 6 h after arrival
- requesting PBM/ transfusion-free therapy but not offered
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic transfusionAnemia is treated by administering donor red cells, and bleeding or coagulopathy by plasma, platelets or other donor blood products. | Biological | Control group: Transfusions only, Study group 2: PBM with transfusions |
| Patient Blood ManagementPBM is a strategy to manage the participants own blood. Its focus is on anemia, bleeding and coagulation management (using predominantly pharmaceutical and technological means). | Other | Study group 1: PBM only, Study group 2: PBM with transfusions |
Primary outcome
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)
8 secondary outcomes
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
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
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
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
Readmission
Time frame: From date of admission to hospital until 30 days thereafter
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Derived from this study: PubMed 40880263Lucas M, Stoll R, Dobel KU, Spenner A, Trentino KM, Murray K, Seeber P. Outcomes of Nontransfusable and Transfusable Patients After Major Noncardiac Surgery: A Retrospective Cohort Study. Anesth Analg. 2026 Apr 1;142(4):653-663. doi: 10.1213/ANE.0000000000007718. Epub 2025 Aug 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Seeber principal investigator
HELIOS Klinikum Gotha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Surgery, run by Helios Klinik Gotha/Ohrdruf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06553833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.