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BioGlue as an Adjunct for Structural Repair and Hemostasis in Chinese Acute Type A Aortic Dissections Patients
Sponsor: CryoLife, Inc.
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.
Official title: Multi-center, Randomized, Controlled Clinical Trial of BioGlue Surgical Adhesive as an Adjunct for Structural Repair and Hemostasis in Chinese Patients With Acute Type A Aortic Dissections.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
202
Start Date
2017-11-01
Completion Date
2020-11
Last Updated
2020-05-19
Healthy Volunteers
No
Conditions
Interventions
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
Locations (7)
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