Cell Salvage and Retrograde Autologous Priming

Study Overview
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Brief Summary
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In recent years Patient Blood Management (PBM) has developed into a multifactorial and interdisciplinary concept that focuses on individualized and optimized hemotherapy. Of course, this also applies to the cardiac surgery area (1). In this context, the quality of the intraoperative PBM can be represented by patients scheduled for isolated coronary artery bypass grafting (CABG) and isolated aortic valve replacement (AVR). In a prospective, observational before-and-after protocol, the investigators analysed the impact of the combined use of retrograde autologous priming (RAP) and cell salvage on intraoperative usage of red blood cell concentrates (RBC) (2).

Detailed Description
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200 patients (CABG or AVR) will be monitored using local standard of care in these patients without cell salvage and RAP (control group, CG), followed by 200 patients with cell salvage and RAP (study group, SG). Both groups are defined by elective surgery and hemodynamically stable patients prior to the onset of the cardiopulmonary bypass (CPB). Based on our own data and current data from the literature, the investigators assume that the use of MAT in combination with RAP leads to at least an intraoperative reduction of the erythrocyte consumption of 15%. Consequently, the investigators calculated a case number of approximately 200 patients per group. The study is set up with a control group under previous standard therapy. The data is recorded and analyzed descriptively. Qualitative comparisons will be made in the discussion of previously published data.

Official Title
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Intraoperative Cell Salvage and Retrograde Autologous Priming in Patients Undergoing Isolated Coronary Bypass Grafting and Conventional Aortic Valve Replacement.

Conditions
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Surgery, Hemodynamic Instability

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for cardiac surgery informed written consent Exclusion Criteria: rejection by the patient switching to another procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MAT-RAP group<br>MAT and RAP | |
| historical group<br>standard procedure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of red blood cell concentrates | use of RBC | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | acute renal failure, pulmonary edema, pneumonia, wound infection | through study completion, an average of 1 year | 
| length of stay in hospital | time in hospital after surgery | through study completion, an average of 1 year | 
| hospital mortality | hospital mortality | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cell salvage, length of stay in hospital, mortality