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NCT06612060: BALANCE
Biocompatible Versus Non-coated Extracorporeal Circuits in Cardiac Surgery
NA trial testing Cardiac surgery with the use of extracorporeal circulation in Cardiac Surgery Requiring Cardiopulmonary Bypass in 50 participants. Completed in 31 December 2024.
31 December 2024
Quick facts
| Lead sponsor | Polychronis Antonitsis |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 50 |
| Start date | 1 April 2024 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across Greece |
Drugs / interventions tested
- Cardiac surgery with the use of extracorporeal circulation
Conditions studied
- Cardiac Surgery Requiring Cardiopulmonary Bypass — all drugs for Cardiac Surgery Requiring Cardiopulmonary Bypass →
- Extracorporeal Circulation — all drugs for Extracorporeal Circulation →
Sponsor
Polychronis Antonitsis
Who can join
Adults 18 to 80, any sex, with Cardiac Surgery Requiring Cardiopulmonary Bypass or Extracorporeal Circulation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the present strudy is to investigate whether the use of biocompatible extracorporeal circulation circuits with a special hydrophilic polymer coating without heparin causes a reduction in the activation of the coagulation mechanism and the formation of microthrombi in the circuit tubing. A total of 50 patients undergoing cardiac surgery with extracorporeal circulation will be randomized in two groups using a computer-generated algorithm. The first group (study group) will undergo cardiac surgery with a specialized biocompatible circuit with a hydrophilic coating, while the control group will be operated with the conventional non-coated extracorporeal circulation circuit. During the period of extracorporeal circulation, blood samples will be taken at predetermined times which will be analyzed with the ELISA technique to determine the levels of prothrombin fragments 1+2 (F1+2), thrombin/antithrombin complex (TAT) as well as platelet factor P-selectin. Moreover, sections of the circuit tubes will be examined under electron microscopy for quantitative evaluation of microthrombi detected on the walls. The expected outcome of the study is to establish, with the use of specific biochemical markers and electron microscopy the protective effect of biocompatible coated extracorporeal circulation circuits on the coagulation mechanism and platelet activation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06612060
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cardiac Surgery Requiring Cardiopulmonary Bypass
Currently open trials in the same condition.
- NCT06705855 — A Comparison of Renal vs Limb NIRS for Predicting Cardiac Surgery Associated Acute Kidney Injury · recruiting
- NCT06781294 — SIRAKI 02 Posthoc Analysis. · NA · active not 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 NCT06612060 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Polychronis Antonitsis
- Last refreshed: 28 May 2025
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/NCT06612060.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing