NCT05146726

Patient Blood Management Charité (PBM-Charité): Structured Detection, Differentiated Diagnostics and Therapy of Preoperative Anemia and Use of Machine Autotransfusion in Elective Interventions

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,700 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	BARMER anemia treatment	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.
OTHER	NON-BARMER anemia treatment	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)

Timeline

• Start date: 2022-02-02
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2021-12-07
• Last updated: 2025-07-02

Locations

1 site across 1 country: Germany