Cell Salvage and Retrograde Autologous Priming

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792814
• Other study ID #: IN-MAT_RAP_01
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: March 2021
• Source: University Hospital Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• scheduled for cardiac surgery
• informed written consent

Exclusion Criteria:

• rejection by the patient
• switching to another procedure

Related Conditions & MeSH terms

• Hemodynamic Instability
• Surgery

Locations

Country	Name	City	State
Germany	GERMANY - Universitätsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin	Kiel	Deutschland (deu)

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. Review. Erratum in: Medicine (Baltimore). 2018 Apr;97(17):e0640. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of red blood cell concentrates	use of RBC	through study completion, an average of 1 year
Secondary	postoperative complications	acute renal failure, pulmonary edema, pneumonia, wound infection	through study completion, an average of 1 year
Secondary	length of stay in hospital	time in hospital after surgery	through study completion, an average of 1 year
Secondary	hospital mortality	hospital mortality	through study completion, an average of 1 year