Clinical trial NCT04792814: Cell Salvage and Retrograde Autologous Priming
Official title: Intraoperative Cell Salvage and Retrograde Autologous Priming in Patients Undergoing Isolated Coronary Bypass Grafting and Conventional Aortic Valve Replacement.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Hemodynamic Instability
Keywords: cell salvage
length of stay in hospital
mortality
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: heart surgery patients (CABG and aortic valve replacement)

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).

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.

Eligibility criteria: Inclusion Criteria:

* scheduled for cardiac surgery
* informed written consent

Exclusion Criteria:

* rejection by the patient
* switching to another procedure

Primary outcomes:
measure: number of red blood cell concentrates
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: postoperative complications
timeFrame: through study completion, an average of 1 year
measure: length of stay in hospital
timeFrame: through study completion, an average of 1 year
measure: hospital mortality
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin
state: Deutschland (deu)
city: Kiel
country: Germany
facility: GERMANY - Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: UKSH, Campus Kiel
name: Jochen Renner, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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. No abstract available.
citation: 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.