AnemiaNCT05146726
Patient Blood Management Charité (PBM-Charité): Structured Detection, Differentiated Diagnostics and Therapy of Preoperative Anemia and Use of Machine Autotransfusion in Elective Interventions
An observational study of Anemia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of patient blood management is to reduce the risks of perioperative anemia- and transfusion-associated complications by limiting the use and the need for allogeneic blood transfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- BARMER anemia treatment and NON-BARMER anemia treatment
- Type of treatment
- Injection or infusion
- How many people
- 2,700 participants
- Where
- 1 siteGermany
- Study dates
- 2 Feb 2022to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients with preoperative anemia and an electivesurgical intervention with a probability of transfusion > 10%
Who may be able to join
- age ≥ 18 years
- male and female patients
- patients eligible for inclusion: by the patient, preoperatively
- patients who are insured with BARMER
- patients with preoperative anemia and an elective (N5) surgical intervention with a probability of transfusion > 10%
- additionally for the use of MAT:
Show all 12Show fewer
- indication of machine autotransfusion
- high blood loss (> 500ml / 10-20 % of estimated blood volume) beside of indication interventions (surgery under dual platelet inhibition, high individual bleeding risk, special antibodies / rare blood group, rejection of allogeneic blood)
- -Data since September 2021-February 2024 of patients who are not insured with BARMER with elective (N5) interventions with a transfusion probability > 10% (indication list) with a preoperatively existing anemia
- additionally for the use of MAT:
- indication of machine autotransfusion
- high blood loss (> 500ml / 10-20 % of estimated blood volume) beside of indication interventions (surgery under dual platelet inhibition, high individual bleeding risk, special antibodies / rare blood group, rejection of allogeneic blood)
Who cannot join
- patients with emergency interventions
- rejection of study participation
- pregnancy, elective caesarean section or breastfeeding
- not enough German language skills
- accommodation in an institution because of judicial or administrative order
- employee of Charité
- missing of declaration of consent
- Retrospective:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin
Berlin, 13353
Claudia Spies, MD, Prof., +49 30 450 55 10 01, claudia.spies@charite.de
Lutz Kaufner, MD
About this study
Official title: Patient Blood Management Charité (PBM-Charité): ): Cohort Study About Structured Detection, Differentiated Diagnostics and Therapy of Preoperative Anemia and Use of Machine Autotransfusion in Elective Interventions
The aim of patient blood management is to reduce the risks of perioperative anemia- and transfusion-associated complications by limiting the use and the need for allogeneic blood transfusion.
Read the detailed description
Background of this multimodal, multidisciplinary concept are numerous studies that have shown an association between preoperative anemia and/or a perioperative transfusion and a worse treatment outcome concerning morbidity and mortality. Diagnosis and therapy of preoperative anemia and the use of machine autotransfusion are central components of this integrated supply concept based on the S3 guideline "Präoperative Anämie", which need to be incorporated into the clinical processes.
Therefore, all patients undergoing elective surgery with a probability of transfusion > 10% receive an anemia detection during their premedication visit. Patients who are insured with BARMER also get anemia diagnostic and therapy. Patients of other health insurances receive a recommendation to anemia diagnostics and therapy sent to surgical department. Based on an analysis of the primary and secondary endpoints of this prospective cohort study, the implementation of the mentioned guideline-compliant measures in everyday clinical practice and the effectiveness of an IV-PBM (Patient blood management) are to be examined. Thus, if necessary, other health insurances could join the patient blood management (PBM) IV concept. The aim is to provide evidence of an improved quality of treatment and the generalized application of PBM measures within the scope of the innovative PBM care form described.
- Conditions
- Anemia
- Being tested
- BARMER anemia treatment, NON-BARMER anemia treatment
- Keywords
- Transfusion, Machine autotransfusion
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BARMER anemia treatmentOther
BARMER insured patients are informed about the machine autotransfusion directly by the patient blood management (PBM) service and its intraoperative use is organized. The aim of these measures is to ensure that the intraoperative transfusion trigger does not fall below the intraoperative transfusion trigger by integrating the PBM into standard care and to avoid a perioperative transfusion. In addition, a postoperative treatment recommendation is made for the cause-related anemia treatment, e.g. in order to reduce the risk of a renewed anemia-related perioperative transfusion risk in the event of a possible follow-up operation or other elective operations.
NON-BARMER anemia treatmentOther
Patients not insured with BARMER also receive early anemia detection, selection according to indication intervention (transfusion probability> 10%) and evaluation for machine autotransfusion through the above-mentioned patient blood management (PBM) restructuring of standard care. In the case of preoperative anemia before an indication intervention and / or an intervention with machine autotransfusion application, the operating clinic will be given a recommendation by the PBM service for the diagnosis and treatment of the preoperative anemia and / or the use of the machine autotransfusion (implementation is the responsibility of the operating clinic)
| Study group | Role | What they receive |
|---|---|---|
| Prospective BARMER insured patients | Group I: BARMER insured patients with preoperative anemia and an elective (N5) surgical intervention with a probability of transfusion > 10%.
Central measures in this group are the IV contract for the creation of an organizational and financing structure for the guideline-compliant detection, diagnosis and treatment of preoperative anemia and the evaluation of the machine autotransfusion as part of the preoperative premedication visit in anesthesiology (implementation is the responsibility of the patient blood management (PBM) service). Receives: Other: BARMER anemia treatment | |
| Retrospective patients insured with another statutory health insurer than BARMER | Group II: Patients not insured with BARMER and with preoperative anemia and an elective (N5) surgical intervention with a probability of transfusion > 10% and receive early anemia detection. Receives: Other: NON-BARMER anemia treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients
The amount of patients with differential diagnostics and causally appropriate therapy of a preoperative anemia of all patients with preoperative anemia before an elective surgical intervention with a probability of transfusion > 10% at study completion date = third year after start date (implementation rate of therapy recommendation). Approximately 9600 patients will be enrolled in the study. The data is evaluated after 3 years.
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Secondary outcomes (24)
Number of patients
The amount of patients with differential diagnostics and causally appropriate therapy of a preoperative anemia of all patients with preoperative anemia before an elective surgical intervention with a probability of transfusion > 10% after the first and second year after start date (implementation rate of therapy). The data of 2 is evaluated after 1 year and 2 years.
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Number of machine autotransfusion respectively autologous transfusion
Number of patients which received machine autotransfusion
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Rate of transfused patients
Number of patients which received transfusions
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
∆Hb before therapy of anemia and before surgical intervention
Difference between Hemoglobin before therapy of anemia and Hemoglobin before surgical intervention.
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Number of allogeneic transfusions
Number of red cell concentrates per patient
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Treatment period
Treatment period between begin of anemia therapy and surgical intervention
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Treatment dose of anemia therapeutics in relation to ∆Hemoglobin
Treatment dose of anemia therapeutics in relation to the difference between Hemoglobin before begin of anemia therapy and the Hemoglobin before surgical intervention
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Side effects 1
Side effects of anemia therapeutics
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Side effects 1
Type of side effects of anemia therapeutics
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Differences of secondary outcome measures
Differences of secondary outcome measures 2. - 10. mentioned above between long term and short term treatment (anemia therapy, long term treatment >3 weeks preoperative, short term treatment 1 - 3 days preoperative).
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Anemia course
Change of Hemoglobin during hospital stay until hospital discharge
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Length of hospital stay
Length of stay at the hospital
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Length of intensive care unit stay
Length of stay at the intensive care unit
Measured: The participants are followed up until the end of hospital stay, an expected average of 3 days
Rate and type of postoperative complications
Rate and type of Organ complications which are documented in the hospital records.
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Side effects 2
Type of side effects of machine autotransfusion
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Rate of side effects
Rate of side effects of machine autotransfusion
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Volumes of collected blood
Volumes of collected blood from Machine autotransfusion
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Retransfused blood
Retransfused blood from Machine autotransfusion
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 1
Quality indicators for machine autotransfusion as process time
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 2
Quality indicators for machine autotransfusion as operating time
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 3
Quality indicators for machine autotransfusion as number of washing processes
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 4
Quality indicators for machine autotransfusion as surgery department
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 5
Quality indicators for machine autotransfusion as patient population
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Rate of In-hospital mortality
Mortality is measured during hospital stay
Measured: The participants are followed up until the end of hospital stay, an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start2 Feb 2022
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 2,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146726
- Sponsor's protocol ID
- Patient Blood Management
- Status last verified
- Jul 2025
- First submitted
- 16 Nov 2021
- Last updated
- 2 Jul 2025
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Blood Management Charité (PBM-Charité): ): Cohort Study About Structured Detection, Differentiated Diagnostics and Therapy of Preoperative Anemia and Use of Machine Autotransfusion in Elective Interventions
- ClinicalTrials.gov ID
- NCT05146726
- Acronym / sponsor ID
- Patient Blood Management
- Conditions
- Anemia
- Keywords
- Transfusion, Machine autotransfusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 7 Dec 2021 (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 aim of patient blood management is to reduce the risks of perioperative anemia- and transfusion-associated complications by limiting the use and the need for allogeneic blood transfusion.
Detailed description
Background of this multimodal, multidisciplinary concept are numerous studies that have shown an association between preoperative anemia and/or a perioperative transfusion and a worse treatment outcome concerning morbidity and mortality. Diagnosis and therapy of preoperative anemia and the use of machine autotransfusion are central components of this integrated supply concept based on the S3 guideline "Präoperative Anämie", which need to be incorporated into the clinical processes.
Therefore, all patients undergoing elective surgery with a probability of transfusion > 10% receive an anemia detection during their premedication visit. Patients who are insured with BARMER also get anemia diagnostic and therapy. Patients of other health insurances receive a recommendation to anemia diagnostics and therapy sent to surgical department. Based on an analysis of the primary and secondary endpoints of this prospective cohort study, the implementation of the mentioned guideline-compliant measures in everyday clinical practice and the effectiveness of an IV-PBM (Patient blood management) are to be examined. Thus, if necessary, other health insurances could join the patient blood management (PBM) IV concept. The aim is to provide evidence of an improved quality of treatment and the generalized application of PBM measures within the scope of the innovative PBM care form described.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective BARMER insured patients | – | Other: BARMER anemia treatmentGroup I: BARMER insured patients with preoperative anemia and an elective (N5) surgical intervention with a probability of transfusion > 10%. Central measures in this group are the IV contract for the creation of an organizational and financing structure for the guideline-compliant detection, diagnosis and treatment of preoperative anemia and the evaluation of the machine autotransfusion as part of the preoperative premedication visit in anesthesiology (implementation is the responsibility of the patient blood management (PBM) service). |
| Retrospective patients insured with another statutory health insurer than BARMER | – | Other: NON-BARMER anemia treatmentGroup II: Patients not insured with BARMER and with preoperative anemia and an elective (N5) surgical intervention with a probability of transfusion > 10% and receive early anemia detection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with preoperative anemia and an electivesurgical intervention with a probability of transfusion > 10%
Key inclusion criteria (12 listed)
- age ≥ 18 years
- male and female patients
- patients eligible for inclusion: by the patient, preoperatively
- patients who are insured with BARMER
- patients with preoperative anemia and an elective (N5) surgical intervention with a probability of transfusion > 10%
Key exclusion criteria (8 listed)
- patients with emergency interventions
- rejection of study participation
- pregnancy, elective caesarean section or breastfeeding
- not enough German language skills
- accommodation in an institution because of judicial or administrative order
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 |
|---|---|---|
| BARMER anemia treatmentBARMER insured patients are informed about the machine autotransfusion directly by the patient blood management (PBM) service and its intraoperative use is organized. The aim of these measures is to ensure that the intraoperative transfusion trigger does not fall below the intraoperative transfusion trigger by integrating the PBM into standard care and to avoid a perioperative transfusion. In addition, a postoperative treatment recommendation is made for the cause-related anemia treatment, e.g. in order to reduce the risk of a renewed anemia-related perioperative transfusion risk in the event of a possible follow-up operation or other elective operations. | Other | Prospective BARMER insured patients |
| NON-BARMER anemia treatmentPatients not insured with BARMER also receive early anemia detection, selection according to indication intervention (transfusion probability> 10%) and evaluation for machine autotransfusion through the above-mentioned patient blood management (PBM) restructuring of standard care. In the case of preoperative anemia before an indication intervention and / or an intervention with machine autotransfusion application, the operating clinic will be given a recommendation by the PBM service for the diagnosis and treatment of the preoperative anemia and / or the use of the machine autotransfusion (implementation is the responsibility of the operating clinic) | Other | Retrospective patients insured with another statutory health insurer than BARMER |
Primary outcome
Number of patients
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
The amount of patients with differential diagnostics and causally appropriate therapy of a preoperative anemia of all patients with preoperative anemia before an elective surgical intervention with a probability of transfusion > 10% at study completion date = third year after start date (implementation rate of therapy recommendation). Approximately 9600 patients will be enrolled in the study. The data is evaluated after 3 years.
24 secondary outcomes
Number of patients
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Number of machine autotransfusion respectively autologous transfusion
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Rate of transfused patients
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
∆Hb before therapy of anemia and before surgical intervention
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Number of allogeneic transfusions
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Treatment period
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Treatment dose of anemia therapeutics in relation to ∆Hemoglobin
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Side effects 1
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Side effects 1
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Differences of secondary outcome measures
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Anemia course
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Length of hospital stay
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Length of intensive care unit stay
Time frame: The participants are followed up until the end of hospital stay, an expected average of 3 days
Rate and type of postoperative complications
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Side effects 2
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Rate of side effects
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Volumes of collected blood
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Retransfused blood
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 1
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 2
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 3
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 4
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicator 5
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Rate of In-hospital mortality
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- 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.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
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 Anemia, run by Charite University, Berlin, Germany 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 12 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Spies, MD, Prof. (+49 30 450 55 11 02, claudia.spies@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients (time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days). 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 2 Jul 2025.