Cell Salvage and Retrograde Autologous Priming

NCT04792814 | Completed

• 1 other identifier: IN-MAT_RAP_01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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).

Conditions

Surgery; Hemodynamic Instability

Keywords

cell salvage; length of stay in hospital; mortality

Outcome Measures

Primary Outcomes (1)

• number of red blood cell concentrates

  use of RBC

  through study completion, an average of 1 year

Secondary Outcomes (3)

• postoperative complications

  through study completion, an average of 1 year

• length of stay in hospital

  through study completion, an average of 1 year

• hospital mortality

  through study completion, an average of 1 year

Study Arms (2)

MAT-RAP group

MAT and RAP

historical group

standard procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

heart surgery patients (CABG and aortic valve replacement)

You may qualify if:

• scheduled for cardiac surgery
• informed written consent

You may not qualify if:

• rejection by the patient
• switching to another procedure

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (2)

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

Kiel, Deutschland (deu), 24105, Germany

Location

GERMANY - Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, 24109, Germany

Location

Related Publications (2)

• 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.

  PMID: 29029100 BACKGROUND

• 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.

  PMID: 27495095 BACKGROUND

Study Officials

• Jochen Renner, Prof. Dr.

  UKSH, Campus Kiel

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Jochen Renner

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: March 11, 2021
• Study Start: June 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)