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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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 di

Первичные конечные точки

• Number of patients [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days]

Вторичные конечные точки (12)

• Number of patients [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days]
• Number of machine autotransfusion respectively autologous transfusion [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days]
• Rate of transfused patients [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days]
• ∆Hb before therapy of anemia and before surgical intervention [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days]
• Number of allogeneic transfusions [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days]
• Treatment period [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days]
• Treatment dose of anemia therapeutics in relation to ∆Hemoglobin [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days]
• Side effects 1 [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days]
• Side effects 1 [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days]
• Differences of secondary outcome measures [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days]
• Anemia course [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days]
• Length of hospital stay [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days]

Критерии участия

Prospective:

Критерии включения

• 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)

Критерии исключения

• 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:

Критерии включения

-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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

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

Идентификаторы

NCT: NCT05146726 · Patient Blood Management

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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