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NCT Number: NCT04792814

Cell Salvage and Retrograde Autologous Priming

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).

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Key information

Conditions

Surgery Hemodynamic Instability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • scheduled for cardiac surgery
  • informed written consent

Exclusion criteria

  • rejection by the patient
  • switching to another procedure

Treatment and study plan

Primary outcomes

  1. number of red blood cell concentrates

    Time frame: through study completion, an average of 1 year

    use of RBC

Secondary outcomes

  1. postoperative complications

    Time frame: through study completion, an average of 1 year

    acute renal failure, pulmonary edema, pneumonia, wound infection

  2. length of stay in hospital

    Time frame: through study completion, an average of 1 year

    time in hospital after surgery

  3. hospital mortality

    Time frame: through study completion, an average of 1 year

    hospital mortality

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2021
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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