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

  • STATUS
    Recruiting
  • End date
    Sep 25, 2024
  • participants needed
    2700
  • sponsor
    Charite University, Berlin, Germany
Updated on 4 October 2022
anemia

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.

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.

Details
Condition Anemia
Treatment BARMER anemia treatment, NON-BARMER anemia treatment
Clinical Study IdentifierNCT05146726
SponsorCharite University, Berlin, Germany
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Data since September 2021-June 2022 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
high blood loss (> 500ml / 10-20 % of estimated blood volume) beside of indication
indication of machine autotransfusion
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
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