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NCT05146726 | RECRUITING | Anemia

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

Charite University, Berlin, Germany

Information provided by (Responsible Party):

Claudia Spies

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.

Condition or disease

Anemia

Intervention/treatment

BARMER anemia treatment

NON-BARMER anemia treatment

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 2700 participants
Official Title : 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
Actual Study Start Date : 2022-02-02
Estimated Primary Completion Date : 2027-02
Estimated Study Completion Date : 2027-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
Patient Blood Management Charité (PBM-Charité): Structured Detection, Differentiated Diagnostics and Therapy of Preoperative Anemia and Use of Machine Autotransfusion in Elective Interventions

Location Details

NCT05146726

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How to Participate

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Locations

RECRUITING

Germany,

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

Berlin, Germany, 13353