NCT Number: NCT05146726
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Berlin, 13353, Germany
Location status: Recruiting
Claudia Spies, MD, Prof.
CONTACT
Franziska Büttner, MD
SUB_INVESTIGATOR
Lutz Kaufner, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Prospective:
Inclusion criteria
additionally for the use of MAT:
Exclusion criteria
Retrospective:
Inclusion criteria
-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:
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.
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)
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.
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% 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.
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Number of patients which received machine autotransfusion
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Number of patients which received transfusions
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Difference between Hemoglobin before therapy of anemia and Hemoglobin before surgical intervention.
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Number of red cell concentrates per patient
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Treatment period between begin of anemia therapy and surgical intervention
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 the difference between Hemoglobin before begin of anemia therapy and the Hemoglobin before surgical intervention
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Side effects of anemia therapeutics
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Type of side effects of anemia therapeutics
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
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).
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Change of Hemoglobin during hospital stay until hospital discharge
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Length of stay at the hospital
Time frame: The participants are followed up until the end of hospital stay, an expected average of 3 days
Length of stay at the intensive care unit
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Rate and type of Organ complications which are documented in the hospital records.
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Type of side effects of machine autotransfusion
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Rate of side effects of machine autotransfusion
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Volumes of collected blood from Machine autotransfusion
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Retransfused blood from Machine autotransfusion
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicators for machine autotransfusion as process time
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicators for machine autotransfusion as operating time
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicators for machine autotransfusion as number of washing processes
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicators for machine autotransfusion as surgery department
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Quality indicators for machine autotransfusion as patient population
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Mortality is measured during hospital stay
Contact information is provided by the study sponsor or research team.
Charite University, Berlin, Germany
Other
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
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