Patient Blood ManagementPBMNCT06363214
Impact of Patient Blood Management (PBM) at the Schulthess Clinic
An observational study of Patient Blood Management, run by Schulthess Klinik.
Trial summary
Aim of this study is to analyze the transfusion requirements of allogenic blood products at the Schulthess Clinic for patients that had major orthopedic or major spine surgery between 2019 and 2024 order to identify patients at risk for transfusion. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Patient Blood Management
- What is being tested?
- Patient blood management
- Type of treatment
- Surgery or procedure
- How many people
- 16,000 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Apr 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 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing elective major orthopedic or spine surgery at the Schulthess Clinic between 2019 and 2024.
Who may be able to join
- Patients undergoing primary joint arthroplasties or revision surgery: CHOP Code: 81.51, 81.52, 81.52, 81.54
- Patients undergoing major spine surgery: CHOP Code: 7A.6, 7A.7
Who cannot join
- Patients who did not sign general informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Patient Blood Management (PBM) at the Schulthess Clinic A Quality Assurance and Quality Control Project in Major Orthopaedic and Spine Surgery
Aim of this study is to analyze the transfusion requirements of allogenic blood products at the Schulthess Clinic for patients that had major orthopedic or major spine surgery between 2019 and 2024 order to identify patients at risk for transfusion. Moreover, impact of transfusion requirements and other measures of PBM on patient outcomes will be assessed. These data are required to further improve PBM at the Schulthess Clinic.
Read the detailed description
At the Schulthess Clinic a significant reduction of RBC's, fresh frozen plasma (FFP) and platelets transfusion could be observed between 2018 and 2022 during the stepwise introduction of PBM for all patients undergoing major orthopedic and spine surgery. RBC, FFP and PT transfusion declined by 76.3%, 73.5% and 99.2% over the 5-year period. Unfortunately however, at the moment no detailed analysis with respect to risk factors for transfusion, specific interventions or outcomes is available. The hypothesis is that the already known reduction of allogenic blood product transfusion at the Schulthess Clinic can be attributed to patients undergoing major primary joint arthroplasties, revision operations and major spine surgery. We assume that patient and procedure related risk factors over time did not significantly change while we expect a major impact of changed transfusion requirements and the stepwise PBM implementation on patient outcomes.
- Conditions
- Patient Blood Management
- Being tested
- Patient blood management
- Keywords
- blood transfusion, orthopedic surgery, coagulation
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient blood managementProcedure or surgery
Perioperative optimization of hemoglobin level, perioperative minimization of blood loss, increase of anemia tolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative transfusion rates
Administration of red blood cells, fresh frozen plasma and platelet concentrates (units)
Measured: 2019-2024
Risk factors for perioperative transfusion Risk factors for perioperative transfusion Risk factorsfor perioperative transfusion
Identification of patient groups with increased transfusion rates
Measured: 2019-2024
Secondary outcomes (2)
Perioperative rates of coagulation products administered
Administration of prothrombin complex, fibrinogen, other coagulation factors
Measured: 2019-2024
Clinical outcomes
- Infections: Wound, sepsis, drug-resistant, Clostridium difficilis.
- Ischemic events: TIA, cerebrovascular, myocardial
- Thrombotic: Deep venous thrombosis (DVT), pulmonary embolism (Barrie et al.)
- Renal failure
- Pulmonary failure
Measured: 2019-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Blood ManagementStudies 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
- 16,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Hofer, Schulthess Klinik
- Investigators
- Christoph K Hofer, MD, Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363214
- Sponsor's protocol ID
- ANEST-0002
- Acronym
- PBM
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient Blood Management (PBM) at the Schulthess Clinic A Quality Assurance and Quality Control Project in Major Orthopaedic and Spine Surgery
- ClinicalTrials.gov ID
- NCT06363214
- Acronym / sponsor ID
- PBM / ANEST-0002
- Conditions
- Patient Blood Management
- Keywords
- blood transfusion, orthopedic surgery, coagulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 12 Apr 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.
Aim of this study is to analyze the transfusion requirements of allogenic blood products at the Schulthess Clinic for patients that had major orthopedic or major spine surgery between 2019 and 2024 order to identify patients at risk for transfusion. Moreover, impact of transfusion requirements and other measures of PBM on patient outcomes will be assessed. These data are required to further improve PBM at the Schulthess Clinic.
Detailed description
At the Schulthess Clinic a significant reduction of RBC's, fresh frozen plasma (FFP) and platelets transfusion could be observed between 2018 and 2022 during the stepwise introduction of PBM for all patients undergoing major orthopedic and spine surgery. RBC, FFP and PT transfusion declined by 76.3%, 73.5% and 99.2% over the 5-year period. Unfortunately however, at the moment no detailed analysis with respect to risk factors for transfusion, specific interventions or outcomes is available. The hypothesis is that the already known reduction of allogenic blood product transfusion at the Schulthess Clinic can be attributed to patients undergoing major primary joint arthroplasties, revision operations and major spine surgery. We assume that patient and procedure related risk factors over time did not significantly change while we expect a major impact of changed transfusion requirements and the stepwise PBM implementation on patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing elective major orthopedic or spine surgery at the Schulthess Clinic between 2019 and 2024.
Key inclusion criteria (2 listed)
- Patients undergoing primary joint arthroplasties or revision surgery: CHOP Code: 81.51, 81.52, 81.52, 81.54
- Patients undergoing major spine surgery: CHOP Code: 7A.6, 7A.7
Key exclusion criteria (1 listed)
- Patients who did not sign general informed consent
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 |
|---|---|---|
| Patient blood managementPerioperative optimization of hemoglobin level, perioperative minimization of blood loss, increase of anemia tolerance | Procedure or surgery | – |
Primary outcome
Perioperative transfusion rates
Time frame: 2019-2024
Administration of red blood cells, fresh frozen plasma and platelet concentrates (units)
Risk factors for perioperative transfusion Risk factors for perioperative transfusion Risk factorsfor perioperative transfusion
Time frame: 2019-2024
Identification of patient groups with increased transfusion rates
2 secondary outcomes
Perioperative rates of coagulation products administered
Time frame: 2019-2024
Clinical outcomes
Time frame: 2019-2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- 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.
Christoph K Hofer, MD principal investigator
Schulthess Klinik
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Blood Management, run by Schulthess Klinik.
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 1 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 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Christoph K Hofer, MD (00413857462, christoph.hofer@kws.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative transfusion rates (time frame: 2019-2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2024.