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

Charité University Medicine Berlin

Status: Enrolling

Conditions: Anemia

Treatments: Other: BARMER anemia treatment; Other: NON-BARMER anemia treatment

Study type: Observational

Funder types: Other

Identifiers

NCT05146726

Patient Blood Management

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Prospective:

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)

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:

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:

• 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)

Trial design

2,700 participants in 2 patient groups

Prospective BARMER insured patients

Description:

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).

Treatment:

Other: BARMER anemia treatment

Retrospective patients insured with another statutory health insurer than BARMER

Description:

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.

Treatment:

Other: NON-BARMER anemia treatment