Cell Salvage and Retrograde Autologous Priming

NCT ID: NCT04792814

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-10-31

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.

Conditions

Surgery; Hemodynamic Instability

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

MAT-RAP group

MAT and RAP

No interventions assigned to this group

historical group

standard procedure

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• scheduled for cardiac surgery
• informed written consent

Exclusion Criteria

• rejection by the patient
• switching to another procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Dr. Jochen Renner

Prof. Dr. med. Jochen Renner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jochen Renner, Prof. Dr.

Role: STUDY_CHAIR

UKSH, Campus Kiel

Locations

Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin

Kiel, Deutschland (deu), Germany

GERMANY - Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 29029100 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27495095 (View on PubMed)

Other Identifiers

IN-MAT_RAP_01

Identifier Type: -

Identifier Source: org_study_id