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.

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).

Study Overview

• Status: Completed
• Conditions: Surgery; Hemodynamic Instability

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Germany
  • Deutschland (deu)
    • Kiel, Deutschland (deu), Germany, 24105
      • Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24109
      • GERMANY - Universitätsklinikum Schleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

heart surgery patients (CABG and aortic valve replacement)

Description

Inclusion Criteria:

• scheduled for cardiac surgery
• informed written consent

Exclusion Criteria:

• rejection by the patient
• switching to another procedure

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
MAT-RAP group; MAT and RAP
historical group; standard procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of red blood cell concentrates	use of RBC	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	acute renal failure, pulmonary edema, pneumonia, wound infection	through study completion, an average of 1 year
length of stay in hospital	time in hospital after surgery	through study completion, an average of 1 year
hospital mortality	hospital mortality	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Investigators: Study Chair: Jochen Renner, Prof. Dr., UKSH, Campus Kiel

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Medicine (Baltimore). 2018 Apr;97(17):e0640.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: mortality; cell salvage; length of stay in hospital
• Other Study ID Numbers: IN-MAT_RAP_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No