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Cell Salvage and Retrograde Autologous Priming

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04792814
Enrollment
200
Registered
2021-03-11
Start date
2018-06-01
Completion date
2019-10-31
Last updated
2021-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability, Surgery

Keywords

cell salvage, length of stay in hospital, mortality

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.

Interventions

None listed

Sponsors

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* scheduled for cardiac surgery * informed written consent

Exclusion criteria

* rejection by the patient * switching to another procedure

Design outcomes

Primary

MeasureTime frameDescription
number of red blood cell concentratesthrough study completion, an average of 1 yearuse of RBC

Secondary

MeasureTime frameDescription
length of stay in hospitalthrough study completion, an average of 1 yeartime in hospital after surgery
hospital mortalitythrough study completion, an average of 1 yearhospital mortality
postoperative complicationsthrough study completion, an average of 1 yearacute renal failure, pulmonary edema, pneumonia, wound infection

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026