Clinical Safety of a PBM ProgramNCT02147795
The German Patient Blood Management Network
An observational study of Clinical Safety of a PBM Program, run by Johann Wolfgang Goethe University Hospital at 2 sites in Germany.
Trial summary
This epidemiological trial will determine whether the implementation of a PBM program is safe and effective in terms of clinical outcome compared to a pre-implementation cohort Primary endpoint is a composite outcome comprising in-hospital myocardial infarction, stroke, acute renal failure, death of any cause… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Safety of a PBM Program
- How many people
- 1,000,000 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2012to Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult surgical patients
Who may be able to join
- all surgeries with a general or local anaesthetic
- minimum hospital stay of 24 h
- ≥ 18 years
Who cannot join
- < 18 years
- ophthalmologic or dermatologic or outpatient surgery
- all non-surgical anesthetic procedures
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Goethe University Hospital
Frankfurt am Main, Hesse, 60590
Kai Zacharowski, MD PhD, +49-69-6301-5998, kai.zacharowski@kgu.de
- Recruiting
University Hospital Würzburg
Würzburg
Patrick Meybohm, MD, meybohm_p@ukw.de
About this study
Official title: Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients
- This epidemiological trial will determine whether the implementation of a PBM program is safe and effective in terms of clinical outcome compared to a pre-implementation cohort
- Primary endpoint is a composite outcome comprising in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital in patients before and after implementation of the PBM program.
- Secondary endpoints are the length of stay on the intensive care unit, total hospital stay and the quantitative utilization of allogeneic RBC units, platelet concentrates, other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors, and cell saver systems during hospital stay.
- The primary aim is to prove non-inferiority of the intervention (PBM) group when compared with the control group stratified by center.
Read the detailed description
Background: The transfusion of allogeneic red blood cell units might be associated with increased morbidity and mortality due to infectious, immunological, pulmonary and thromboembolic complications. However, transfusion practice currently varies significantly between hospitals and even between physicians and Patient Blood Management programs have not been implemented nationwide in Germany yet. Patient Blood Management (PBM) concepts aim to identify and optimize patients at risk of allogeneic blood transfusions, to promote blood-sparing techniques and restrictive transfusion practices. A rational use of red blood cell concentrates and safe clinical transfusion practice is mandatory. The purpose of the German PBM network is to evaluate the safety of a standardized, evidence-based Patient Blood management concept.
Study Design and Methods: This epidemiological study is a follow-up of a study that is already being carried out in four German university hospitals. This new prospective, multi-centre trial comprises approximately 20 different hospitals of varying size and levels of patient care. A patient-centred, evidence-based Patient Blood Management program will be enrolled in each of these hospitals reforming the care of adult patients undergoing any type of surgery. This PBM program includes the following three main pillars: 1) preoperative optimization of hemoglobin levels in high-risk patients with anaemia, 2) standardization of transfusion practice and transfusion triggers according to evidence-based guidelines and 3) alternatives to transfusion of allogeneic RBC concentrates and blood-sparing techniques (like routine use of cell saver systems, point-of-care diagnostics, optimized coagulation management, restrictive blood sampling).
- Conditions
- Clinical Safety of a PBM Program
- Keywords
- Patient Blood Management, Red Blood Cell Transfusion Practice, Patient Safety, Anemia, Clinical Outcome, perioperative care
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control cohort | Standard care before implementation (pre-implementation) | |
| PBM cohort | After implementation of PBM program (post-implementation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Outcome for and after PBM program
composite outcome comprising in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital in patients before and after implementation of the PBM program
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (2)
Length of stay
length of stay on the intensive care unit, total hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
haemotherapy
the quantitative utilization of allogeneic RBC units, platelet concentrates, other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors, and any other haemotherapy (including use of cell salvage
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Clinical Safety of a PBM ProgramStudies 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
- Prospective
- Enrolment
- 1,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma, B. Braun Melsungen AG, CSL Behring, Fresenius Kabi
- Responsible party
- Principal investigator, Professor Kai Zacharowski, M.D., Ph.D., FRCA, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147795
- Sponsor's protocol ID
- PBM01
- Status last verified
- Mar 2023
- First submitted
- 13 May 2014
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meybohm P, Schmitt E, Choorapoikayil S, Hof L, Old O, Muller MM, Geisen C, Seifried E, Baumhove O, de Leeuw van Weenen S, Bayer A, Friederich P, Brautigam B, Friedrich J, Gruenewald M, Elke G, Molter GP, Narita D, Raadts A, Haas C, Schwendner K, Steinbicker AU, Jenke DJ, Thoma J, Weber V, Velten M, Wittmann M, Weigt H, Lange B, Herrmann E, Zacharowski K; German Patient Blood Management Network Collaborators. German Patient Blood Management Network: effectiveness and safety analysis in 1.2 million patients. Br J Anaesth. 2023 Sep;131(3):472-481. doi: 10.1016/j.bja.2023.05.006. Epub 2023 Jun 26.
PubMed 37380568Schmitt E, Meybohm P, Neef V, Baumgarten P, Bayer A, Choorapoikayil S, Friederich P, Friedrich J, Geisen C, Guresir E, Grunewald M, Gutjahr M, Helmer P, Herrmann E, Muller M, Narita D, Raadts A, Schwendner K, Seifried E, Stark P, Steinbicker AU, Thoma J, Velten M, Weigt H, Wiesenack C, Wittmann M, Zacharowski K, Piekarski F; German PBM Network Collaborators. Preoperative anaemia and red blood cell transfusion in patients with aneurysmal subarachnoid and intracerebral haemorrhage - a multicentre subanalysis of the German PBM Network Registry. Acta Neurochir (Wien). 2022 Apr;164(4):985-999. doi: 10.1007/s00701-022-05144-7. Epub 2022 Feb 26.
PubMed 35220460
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients
- ClinicalTrials.gov ID
- NCT02147795
- Acronym / sponsor ID
- PBM01
- Conditions
- Clinical Safety of a PBM Program
- Keywords
- Patient Blood Management, Red Blood Cell Transfusion Practice, Patient Safety, Anemia, Clinical Outcome, perioperative care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Vifor Pharma, B. Braun Melsungen AG, CSL Behring, Fresenius Kabi
- Study start
- Jan 2012
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 May 2014 (estimated)
- 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.
- This epidemiological trial will determine whether the implementation of a PBM program is safe and effective in terms of clinical outcome compared to a pre-implementation cohort
- Primary endpoint is a composite outcome comprising in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital in patients before and after implementation of the PBM program.
- Secondary endpoints are the length of stay on the intensive care unit, total hospital stay and the quantitative utilization of allogeneic RBC units, platelet concentrates, other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors, and cell saver systems during hospital stay.
- The primary aim is to prove non-inferiority of the intervention (PBM) group when compared with the control group stratified by center.
Detailed description
Background: The transfusion of allogeneic red blood cell units might be associated with increased morbidity and mortality due to infectious, immunological, pulmonary and thromboembolic complications. However, transfusion practice currently varies significantly between hospitals and even between physicians and Patient Blood Management programs have not been implemented nationwide in Germany yet. Patient Blood Management (PBM) concepts aim to identify and optimize patients at risk of allogeneic blood transfusions, to promote blood-sparing techniques and restrictive transfusion practices. A rational use of red blood cell concentrates and safe clinical transfusion practice is mandatory. The purpose of the German PBM network is to evaluate the safety of a standardized, evidence-based Patient Blood management concept.
Study Design and Methods: This epidemiological study is a follow-up of a study that is already being carried out in four German university hospitals. This new prospective, multi-centre trial comprises approximately 20 different hospitals of varying size and levels of patient care. A patient-centred, evidence-based Patient Blood Management program will be enrolled in each of these hospitals reforming the care of adult patients undergoing any type of surgery. This PBM program includes the following three main pillars: 1) preoperative optimization of hemoglobin levels in high-risk patients with anaemia, 2) standardization of transfusion practice and transfusion triggers according to evidence-based guidelines and 3) alternatives to transfusion of allogeneic RBC concentrates and blood-sparing techniques (like routine use of cell saver systems, point-of-care diagnostics, optimized coagulation management, restrictive blood sampling).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control cohort | – | –Standard care before implementation (pre-implementation) |
| PBM cohort | – | –After implementation of PBM program (post-implementation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult surgical patients
Key inclusion criteria (3 listed)
- all surgeries with a general or local anaesthetic
- minimum hospital stay of 24 h
- ≥ 18 years
Key exclusion criteria (3 listed)
- < 18 years
- ophthalmologic or dermatologic or outpatient surgery
- all non-surgical anesthetic procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite Outcome for and after PBM program
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
composite outcome comprising in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital in patients before and after implementation of the PBM program
2 secondary outcomes
Length of stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
haemotherapy
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Derived from this study: PubMed 37380568Meybohm P, Schmitt E, Choorapoikayil S, Hof L, Old O, Muller MM, Geisen C, Seifried E, Baumhove O, de Leeuw van Weenen S, Bayer A, Friederich P, Brautigam B, Friedrich J, Gruenewald M, Elke G, Molter GP, Narita D, Raadts A, Haas C, Schwendner K, Steinbicker AU, Jenke DJ, Thoma J, Weber V, Velten M, Wittmann M, Weigt H, Lange B, Herrmann E, Zacharowski K; German Patient Blood Management Network Collaborators. German Patient Blood Management Network: effectiveness and safety analysis in 1.2 million patients. Br J Anaesth. 2023 Sep;131(3):472-481. doi: 10.1016/j.bja.2023.05.006. Epub 2023 Jun 26.
- Derived from this study: PubMed 35220460Schmitt E, Meybohm P, Neef V, Baumgarten P, Bayer A, Choorapoikayil S, Friederich P, Friedrich J, Geisen C, Guresir E, Grunewald M, Gutjahr M, Helmer P, Herrmann E, Muller M, Narita D, Raadts A, Schwendner K, Seifried E, Stark P, Steinbicker AU, Thoma J, Velten M, Weigt H, Wiesenack C, Wittmann M, Zacharowski K, Piekarski F; German PBM Network Collaborators. Preoperative anaemia and red blood cell transfusion in patients with aneurysmal subarachnoid and intracerebral haemorrhage - a multicentre subanalysis of the German PBM Network Registry. Acta Neurochir (Wien). 2022 Apr;164(4):985-999. doi: 10.1007/s00701-022-05144-7. Epub 2022 Feb 26.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Safety of a PBM Program, run by Johann Wolfgang Goethe University Hospital at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai D Zacharowski, Prof, MD, PhD (0049 69 6301 ext. 5998, Direktion.Anaesthesie@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Outcome for and after PBM program (time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks). 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 NCT02147795, which also lists 2 linked publications.
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 10 Mar 2023.