BioGlue as an Adjunct for Structural Repair and Hemostasis in Chinese Acute Type A Aortic Dissections Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
BioGlue Surgical Adhesive: BioGlue (produced by CryoLife in Kennesaw, GA) is a surgical adhesive with two components respectively purified bovine serum albumin (BSA) and Glutaraldehyde (their proportions are 4:1). Crosslinked bonds (covalent bonds) of Glutaraldehyde cross-link the protein on the surface of the tissue and the amino residue of the bovine serum albumin. BioGlue also adheres to the synthetic matrix material by a mechanical interlocking mechanism in the space of graft matrix.
Traditional Surgical Repair: Traditional surgical repair as determined by the surgeon
Study summary
A multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of BioGlue as an adjunct for structural repair and hemostasis to traditional surgical repair in Chinese subject with Acute type A aortic dissections.
Eligibility
Primary outcome measure(s)
- Successful Closure of the False Lumen — This success can be visually confirmed intraoperatively with a TEE (binary yes/no expression for each subject)
Successful closure of the false lumen as determined by intraoperative TEE. With successful closure of the false lumen, a complete disappearance of the false lumen will be achieved.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | China | |
| Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School | Nanjing | China | |
| Nanjing First Hospital | Nanjing | China | |
| Changhai Hospital,The Second Military Medical University | Shanghai | China | |
| Zhongshan Hospital, Fudan University | Shanghai | China | |
| Wuhan Asia Heart Hospital | Wuhan | China | |
| Henan Provincial People's Hospital | Zhengzhou | China |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03369977 on ClinicalTrials.gov ↗ ← All trials in China