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

Study Overview
=================
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.

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

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Other: BARMER anemia treatment
* Other: NON-BARMER anemia treatment


Participation Criteria
=================
Eligibility 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-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: 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective BARMER insured patients<br>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). | Other: BARMER anemia treatment<br>* 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. in order to reduce the risk of a renewed anemia-related perioperative transfusion risk in the event of a possible follow-up operation or other elective operations.<br>|
| Retrospective patients insured with another statutory health insurer than BARMER<br>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. | Other: NON-BARMER anemia treatment<br>* 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 diagnosis and treatment of the preoperative anemia and / or the use of the machine autotransfusion (implementation is the responsibility of the operating clinic)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients | 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. | The participants are followed up until the end of hospital stay, an expected average of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients | 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. | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Number of machine autotransfusion respectively autologous transfusion | Number of patients which received machine autotransfusion | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Rate of transfused patients | Number of patients which received transfusions | 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 | Difference between Hemoglobin before therapy of anemia and Hemoglobin before surgical intervention. | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Number of allogeneic transfusions | Number of red cell concentrates per patient | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Treatment period | Treatment period between begin of anemia therapy and surgical intervention | 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 | Treatment dose of anemia therapeutics in relation to the difference between Hemoglobin before begin of anemia therapy and the Hemoglobin before surgical intervention | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Side effects 1 | Side effects of anemia therapeutics | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Side effects 1 | Type of side effects of anemia therapeutics | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Differences of secondary outcome measures | 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). | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Anemia course | Change of Hemoglobin during hospital stay until hospital discharge | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Length of hospital stay | Length of stay at the hospital | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Length of intensive care unit stay | Length of stay at the intensive care unit | The participants are followed up until the end of hospital stay, an expected average of 3 days | 
| Rate and type of postoperative complications | Rate and type of Organ complications which are documented in the hospital records. | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Side effects 2 | Type of side effects of machine autotransfusion | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Rate of side effects | Rate of side effects of machine autotransfusion | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Volumes of collected blood | Volumes of collected blood from Machine autotransfusion | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Retransfused blood | Retransfused blood from Machine autotransfusion | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Quality indicator 1 | Quality indicators for machine autotransfusion as process time | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Quality indicator 2 | Quality indicators for machine autotransfusion as operating time | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Quality indicator 3 | Quality indicators for machine autotransfusion as number of washing processes | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Quality indicator 4 | Quality indicators for machine autotransfusion as surgery department | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Quality indicator 5 | Quality indicators for machine autotransfusion as patient population | The participants are followed up until the end of hospital stay, an expected average of 7 days | 
| Rate of In-hospital mortality | Mortality is measured during hospital stay | The participants are followed up until the end of hospital stay, an expected average of 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transfusion, Machine autotransfusion