Cell Salvage and Retrograde Autologous Priming

Completed

• Conditions: Surgery; Hemodynamic Instability

• Registration Number: NCT04792814
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Study First Submitted: 2020-12-17
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-10
• Last Update Submitted: 2021-03-10
• Study First Posted: 2021-03-11
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• scheduled for cardiac surgery
• informed written consent

Exclusion Criteria

• rejection by the patient
• switching to another procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of red blood cell concentrates	through study completion, an average of 1 year	use of RBC

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

GERMANY - Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin; 🇩🇪 Kiel, Deutschland (deu), Germany