Patient Blood Management Charité (PBM-Charité): Structured Detection, Differentiated Diagnostics and Therapy of Preoperative Anemia and Use of Machine Autotransfusion in Elective Interventions
- Conditions
- Anemia
- Interventions
- Other: BARMER anemia treatmentOther: NON-BARMER anemia treatment
- Registration Number
- NCT05146726
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2700
- 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)
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective BARMER insured patients BARMER anemia treatment 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). Retrospective patients insured with another statutory health insurer than BARMER NON-BARMER anemia treatment 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.
- Primary Outcome Measures
Name Time Method Number of patients The participants are followed up until the end of hospital stay, an expected average of 7 days The amount of patients with differential diagnostics and causally appropriate therapy of a preoperative anemia of all patients with preoperative anemia before an elective surgical intervention with a probability of transfusion \> 10% at study completion date = third year after start date (implementation rate of therapy recommendation). Approximately 9600 patients will be enrolled in the study. The data is evaluated after 3 years.
- Secondary Outcome Measures
Name Time Method Rate and type of postoperative complications The participants are followed up until the end of hospital stay, an expected average of 7 days Rate and type of Organ complications which are documented in the hospital records.
∆Hb before therapy of anemia and before surgical intervention The participants are followed up until the end of hospital stay, an expected average of 7 days Difference between Hemoglobin before therapy of anemia and Hemoglobin before surgical intervention.
Treatment dose of anemia therapeutics in relation to ∆Hemoglobin 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 the difference between Hemoglobin before begin of anemia therapy and the Hemoglobin before surgical intervention
Anemia course The participants are followed up until the end of hospital stay, an expected average of 7 days Change of Hemoglobin during hospital stay until hospital discharge
Number of patients The participants are followed up until the end of hospital stay, an expected average of 7 days The amount of patients with differential diagnostics and causally appropriate therapy of a preoperative anemia of all patients with preoperative anemia before an elective surgical intervention with a probability of transfusion \> 10% after the first and second year after start date (implementation rate of therapy). The data of 2 is evaluated after 1 year and 2 years.
Treatment period The participants are followed up until the end of hospital stay, an expected average of 7 days Treatment period between begin of anemia therapy and surgical intervention
Side effects 1 The participants are followed up until the end of hospital stay, an expected average of 7 days Type of side effects of anemia therapeutics
Length of intensive care unit stay The participants are followed up until the end of hospital stay, an expected average of 3 days Length of stay at the intensive care unit
Quality indicator 1 The participants are followed up until the end of hospital stay, an expected average of 7 days Quality indicators for machine autotransfusion as process time
Quality indicator 5 The participants are followed up until the end of hospital stay, an expected average of 7 days Quality indicators for machine autotransfusion as patient population
Rate of transfused patients The participants are followed up until the end of hospital stay, an expected average of 7 days Number of patients which received transfusions
Number of allogeneic transfusions The participants are followed up until the end of hospital stay, an expected average of 7 days Number of red cell concentrates per patient
Length of hospital stay The participants are followed up until the end of hospital stay, an expected average of 7 days Length of stay at the hospital
Volumes of collected blood The participants are followed up until the end of hospital stay, an expected average of 7 days Volumes of collected blood from Machine autotransfusion
Quality indicator 4 The participants are followed up until the end of hospital stay, an expected average of 7 days Quality indicators for machine autotransfusion as surgery department
Number of machine autotransfusion respectively autologous transfusion The participants are followed up until the end of hospital stay, an expected average of 7 days Number of patients which received machine autotransfusion
Differences of secondary outcome measures The participants are followed up until the end of hospital stay, an expected average of 7 days Differences of secondary outcome measures 2. - 10. mentioned above between long term and short term treatment (anemia therapy, long term treatment \>3 weeks preoperative, short term treatment 1 - 3 days preoperative).
Quality indicator 3 The participants are followed up until the end of hospital stay, an expected average of 7 days Quality indicators for machine autotransfusion as number of washing processes
Side effects 2 The participants are followed up until the end of hospital stay, an expected average of 7 days Type of side effects of machine autotransfusion
Rate of side effects The participants are followed up until the end of hospital stay, an expected average of 7 days Rate of side effects of machine autotransfusion
Retransfused blood The participants are followed up until the end of hospital stay, an expected average of 7 days Retransfused blood from Machine autotransfusion
Quality indicator 2 The participants are followed up until the end of hospital stay, an expected average of 7 days Quality indicators for machine autotransfusion as operating time
Rate of In-hospital mortality The participants are followed up until the end of hospital stay, an expected average of 7 days Mortality is measured during hospital stay
Trial Locations
- Locations (1)
Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin
🇩🇪Berlin, Germany