SurgeryPBMNCT01820949
Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients
An observational study of Surgery, run by Johann Wolfgang Goethe University Hospital at 4 sites in Germany.
Trial summary
This study will evaluate clinical outcome after the step-wise implementation of a Patient Blood Management (PBM) Program in surgical patients at 4 hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- How many people
- 110,000 participants
- Where
- 4 sitesGermany
- Study dates
- Jan 2013to Sep 2015
- 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 surgical patients over a period of 24 months at 4 hospitals
Who may be able to join
- All non- ambulant, surgical, anesthetized patients (≥18 years)
- General Surgery, Cardiac Surgery, Thoracic Surgery, Trauma Surgery, Vascular Surgery, Urology, Gynecology, Otolaryngology, Neurosurgery, Crania-Maxillofacial Surgery
Who cannot join
- ambulant and all non-surgical anesthetic procedures
- Surgery in the field of Dermatology or Ophthalmology
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
University Hospital Bonn
Bonn
University Hospital Frankfurt
Frankfurt
University Hospital Schleswig-Holstein
Kiel
University Hospital Muenster
Münster
About this study
This study will evaluate clinical outcome after the step-wise implementation of a Patient Blood Management (PBM) Program in surgical patients at 4 hospitals.
Read the detailed description
A PBM program will be implemented stepwise in four University Hospitals, with the intention to optimize preoperative hemoglobin concentration of patients and to standardize transfusion practice within hemotherapy. The PBM program includes 1) an algorithm with the aim to correct preoperative anemia in elective surgery, 2) a strict indication for the transfusion of red blood cells defined by the "Cross-sectional Guidelines for Therapy with Blood Components and Plasma Derivatives" for all surgical patients, and 3) a perioperative checklist for different blood-sparing techniques (e.g. cell-saver, normothermia, reduced blood samples, point-of-care diagnostics for bedside coagulation management).
Primary endpoint: Safety of the use of PBM program will be determined by comparability of the composite outcome (in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital) between patients treated after implementation and patients treated before implementation (control cohort) of the PBM program.
The primary composite endpoint defined as described above will be registered electronically by analysis of Diagnosis Related Groups (DRG) codes. The frequency of these events will be compared between PBM and control cohort stratified by center with a one-sided Mantel-Haenszel test in a non-inferiority setting with significance level of α=2.5% and a non-inferiority margin of 1% for the incidence of the composite endpoint.
- Conditions
- Surgery
- Keywords
- patient blood management, patients safety
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.
Myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsisComposite outcome
Composite endpoint defined as in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (4)
Length of stay on the intensive care unit
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Total hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Total number of red blood cell transfusions during hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Consumption of coagulation factors
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 posted29 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 110,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Schleswig-Holstein, University Hospital, Bonn, University Hospital Muenster, 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
- Investigators
- Kai Zacharowski, MD, PhD, FRCA, Study chair, Goethe UniversityPatrick Meybohm, MD, Principal investigator, Goethe UniversityErhard Seifried, MD, Principal investigator, German Red Cross Blood Service Baden-Württemberg-Hessen, Institute for Transfusion Medicine and Immunohematology of the Goethe University Hospital, FrankfurtEva Herrmann, Principal investigator, Institute of Biostatistics and Mathematical Modeling, Goethe University Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820949
- Sponsor's protocol ID
- 380/12
- Acronym
- PBM
- Status last verified
- Sep 2015
- First submitted
- 19 Mar 2013
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ellermann I, Bueckmann A, Eveslage M, Buddendick H, Latal T, Niehoff D, Geissler RG, Hempel G, Kerkhoff A, Berdel WE, Roeder N, Van Aken HK, Zarbock A, Steinbicker AU. Treating Anemia in the Preanesthesia Assessment Clinic: Results of a Retrospective Evaluation. Anesth Analg. 2018 Nov;127(5):1202-1210. doi: 10.1213/ANE.0000000000003583.
PubMed 29944518Meybohm P, Herrmann E, Steinbicker AU, Wittmann M, Gruenewald M, Fischer D, Baumgarten G, Renner J, Van Aken HK, Weber CF, Mueller MM, Geisen C, Rey J, Bon D, Hintereder G, Choorapoikayil S, Oldenburg J, Brockmann C, Geissler RG, Seifried E, Zacharowski K; PBM-study Collaborators. Patient Blood Management is Associated With a Substantial Reduction of Red Blood Cell Utilization and Safe for Patient's Outcome: A Prospective, Multicenter Cohort Study With a Noninferiority Design. Ann Surg. 2016 Aug;264(2):203-11. doi: 10.1097/SLA.0000000000001747.
PubMed 27163948Meybohm P, Fischer DP, Geisen C, Muller MM, Weber CF, Herrmann E, Steffen B, Seifried E, Zacharowski K; German PBM Study Core Group. Safety and effectiveness of a Patient Blood Management (PBM) program in surgical patients--the study design for a multi-centre prospective epidemiologic non-inferiority trial. BMC Health Serv Res. 2014 Nov 19;14:576. doi: 10.1186/s12913-014-0576-3.
PubMed 25927460
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. 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
- NCT01820949
- Acronym / sponsor ID
- PBM / 380/12
- Conditions
- Surgery
- Keywords
- patient blood management, patients safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110,000 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- University Hospital Schleswig-Holstein, University Hospital, Bonn, University Hospital Muenster, Vifor Pharma, B. Braun Melsungen AG, CSL Behring, Fresenius Kabi
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 Mar 2013 (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 study will evaluate clinical outcome after the step-wise implementation of a Patient Blood Management (PBM) Program in surgical patients at 4 hospitals.
Detailed description
A PBM program will be implemented stepwise in four University Hospitals, with the intention to optimize preoperative hemoglobin concentration of patients and to standardize transfusion practice within hemotherapy. The PBM program includes 1) an algorithm with the aim to correct preoperative anemia in elective surgery, 2) a strict indication for the transfusion of red blood cells defined by the "Cross-sectional Guidelines for Therapy with Blood Components and Plasma Derivatives" for all surgical patients, and 3) a perioperative checklist for different blood-sparing techniques (e.g. cell-saver, normothermia, reduced blood samples, point-of-care diagnostics for bedside coagulation management).
Primary endpoint: Safety of the use of PBM program will be determined by comparability of the composite outcome (in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital) between patients treated after implementation and patients treated before implementation (control cohort) of the PBM program.
The primary composite endpoint defined as described above will be registered electronically by analysis of Diagnosis Related Groups (DRG) codes. The frequency of these events will be compared between PBM and control cohort stratified by center with a one-sided Mantel-Haenszel test in a non-inferiority setting with significance level of α=2.5% and a non-inferiority margin of 1% for the incidence of the composite endpoint.
Study design
- Observational model
- Ecologic or community
- 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
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all surgical patients over a period of 24 months at 4 hospitals
Key inclusion criteria (2 listed)
- All non- ambulant, surgical, anesthetized patients (≥18 years)
- General Surgery, Cardiac Surgery, Thoracic Surgery, Trauma Surgery, Vascular Surgery, Urology, Gynecology, Otolaryngology, Neurosurgery, Crania-Maxillofacial Surgery
Key exclusion criteria (2 listed)
- ambulant and all non-surgical anesthetic procedures
- Surgery in the field of Dermatology or Ophthalmology
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
Myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsisComposite outcome
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Composite endpoint defined as in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital
4 secondary outcomes
Length of stay on the intensive care unit
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Total hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Total number of red blood cell transfusions during hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Consumption of coagulation factors
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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 7 Sep 2015.
- Derived from this study: PubMed 29944518Ellermann I, Bueckmann A, Eveslage M, Buddendick H, Latal T, Niehoff D, Geissler RG, Hempel G, Kerkhoff A, Berdel WE, Roeder N, Van Aken HK, Zarbock A, Steinbicker AU. Treating Anemia in the Preanesthesia Assessment Clinic: Results of a Retrospective Evaluation. Anesth Analg. 2018 Nov;127(5):1202-1210. doi: 10.1213/ANE.0000000000003583.
- Derived from this study: PubMed 27163948Meybohm P, Herrmann E, Steinbicker AU, Wittmann M, Gruenewald M, Fischer D, Baumgarten G, Renner J, Van Aken HK, Weber CF, Mueller MM, Geisen C, Rey J, Bon D, Hintereder G, Choorapoikayil S, Oldenburg J, Brockmann C, Geissler RG, Seifried E, Zacharowski K; PBM-study Collaborators. Patient Blood Management is Associated With a Substantial Reduction of Red Blood Cell Utilization and Safe for Patient's Outcome: A Prospective, Multicenter Cohort Study With a Noninferiority Design. Ann Surg. 2016 Aug;264(2):203-11. doi: 10.1097/SLA.0000000000001747.
- Derived from this study: PubMed 25927460Meybohm P, Fischer DP, Geisen C, Muller MM, Weber CF, Herrmann E, Steffen B, Seifried E, Zacharowski K; German PBM Study Core Group. Safety and effectiveness of a Patient Blood Management (PBM) program in surgical patients--the study design for a multi-centre prospective epidemiologic non-inferiority trial. BMC Health Serv Res. 2014 Nov 19;14:576. doi: 10.1186/s12913-014-0576-3.
- Safety and effectiveness of a Patient Blood Management (PBM) program in surgical patients - the study design for a multi-centre prospective epidemiologic non-inferiority trialLink provided by the sponsor.
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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.
Kai Zacharowski, MD, PhD, FRCA study chair
Goethe University
Patrick Meybohm, MD principal investigator
Goethe University
Erhard Seifried, MD principal investigator
German Red Cross Blood Service Baden-Württemberg-Hessen, Institute for Transfusion Medicine and Immunohematology of the Goethe University Hospital, Frankfurt
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Johann Wolfgang Goethe University Hospital at 4 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 2 inclusion and 2 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 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsisComposite outcome (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 NCT01820949, which also lists 3 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 7 Sep 2015.