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NCT03823521
Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™
Phase 3 trial testing Cardioplegia Solution in Coronary Artery Bypass Surgery in 171 participants. Completed in 18 October 2021.
18 October 2021
Quick facts
| Lead sponsor | Swiss Cardio Technologies AG |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 171 |
| Start date | 20 November 2018 |
| Primary completion | 18 October 2021 |
| Estimated completion | 18 October 2021 |
| Sites | 6 locations across Austria, Germany |
Drugs / interventions tested
- Cardioplegia Solution — full drug profile →
Conditions studied
- Coronary Artery Bypass Surgery — all drugs for Coronary Artery Bypass Surgery →
- Valve Surgery — all drugs for Valve Surgery →
Sponsor
Swiss Cardio Technologies AG
Who can join
Adults 18 to 80, any sex, with Coronary Artery Bypass Surgery or Valve Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-center, open label, single group, observational study designed to evaluate the effects of a Cardioplexol™ preparation and administration training program proposed to cardiac surgeons and cardiotechnicians inexperienced in the use of Cardioplexol™. The training program aims at increasing the efficacy of Cardioplexol administration while reducing the risk of false manipulations. During the training possible risks and consequences of incorrect applications as well as the measures to take in case of administration error, are discussed. The training program includes one standardized theoretical part and one practical part consisting of a direct intra-operative coaching of surgeons practicing their first 2 operations. The effect of the training will then be assessed by evaluating each trained surgeon's 4 next consecutive patients operated with Cardioplexol and without the coach.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A multi-center, open label, single group, observational clinical trial to investigate the effects of training on the administration of Cardioplexol™.
Tevaearai Stahel HT, Taheri N, Winkler A, Hohlfeld J, et al · · 2025 · PMID 40491721 · DOI 10.3389/fcvm.2025.1588088
Verify or expand the search:
- PubMed search for NCT03823521
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cardioplegia Solution
Trials testing the same drug.
- NCT05076604 — Effects of Microplegia on Transfusion Rates After Cardiac Surgery · Phase 4 · completed
Other recruiting trials for Coronary Artery Bypass Surgery
Currently open trials in the same condition.
- NCT05411445 — Study of Role of Blood Microvescicles and Exosomes in Patients With Graft Occlusion After Aortocoronary Bypass Surgery · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03823521 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Swiss Cardio Technologies AG
- Last refreshed: 21 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03823521.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing