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

NCT ID: NCT05146726

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2027-02-28

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

BARMER anemia treatment

Intervention Type: OTHER

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.

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.

NON-BARMER anemia treatment

Intervention Type: OTHER

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)

Interventions

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.

Intervention Type: 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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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:

• 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)

Exclusion Criteria

• 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:

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Head of the Department of Anesthesiology and operative Intensive Care (CCM/CVK), Charité- Universitätsmedizin Berlin

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Claudia Spies, MD, Prof.

Role: CONTACT

claudia.spies@charite.de

+49 30 450 55 11 02

Facility Contacts

Claudia Spies, MD, Prof.

Role: primary

claudia.spies@charite.de

+49 30 450 55 10 01

Other Identifiers

Patient Blood Management

Identifier Type: -

Identifier Source: org_study_id