Cell Salvage and Retrograde Autologous Priming
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| MAT-RAP group MAT and RAP |
|
| historical group standard procedure |
Outcome Measures
Primary Outcome Measures
- number of red blood cell concentrates [through study completion, an average of 1 year]
use of RBC
Secondary Outcome Measures
- postoperative complications [through study completion, an average of 1 year]
acute renal failure, pulmonary edema, pneumonia, wound infection
- length of stay in hospital [through study completion, an average of 1 year]
time in hospital after surgery
- hospital mortality [through study completion, an average of 1 year]
hospital mortality
Eligibility Criteria
Criteria
Inclusion Criteria:
-
scheduled for cardiac surgery
-
informed written consent
Exclusion Criteria:
-
rejection by the patient
-
switching to another procedure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin | Kiel | Deutschland (deu) | Germany | 24105 |
| 2 | GERMANY - Universitätsklinikum Schleswig-Holstein | Kiel | Schleswig-Holstein | Germany | 24109 |
Sponsors and Collaborators
- University Hospital Schleswig-Holstein
Investigators
- Study Chair: Jochen Renner, Prof. Dr., UKSH, Campus Kiel
Study Documents (Full-Text)
None provided.More Information
Publications
- Meybohm P, Choorapoikayil S, Wessels A, Herrmann E, Zacharowski K, Spahn DR. Washed cell salvage in surgical patients: A review and meta-analysis of prospective randomized trials under PRISMA. Medicine (Baltimore). 2016 Aug;95(31):e4490. doi: 10.1097/MD.0000000000004490. Review. Erratum in: Medicine (Baltimore). 2018 Apr;97(17):e0640.
- Pagano D, Milojevic M, Meesters MI, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Boer C. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. Eur J Cardiothorac Surg. 2018 Jan 1;53(1):79-111. doi: 10.1093/ejcts/ezx325.
- IN-MAT_RAP_01