A Prospective, Single-blind, Randomized, Phase II/III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis during Peripheral Vascular Surgery

Instituto Grifols S.A.0 sites312 target enrollmentApril 27, 2009

Overview

No summary available.

Registry

who.int

Start Date

April 27, 2009

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\)Signed written Informed Consent Form (ICF)
•2\) Male or female
•3\) At least 18 years of age with no upper age limit
•4\) Willingness and ability to complete all protocol requirements
•5\) Hemoglobin (Hgb) \= 9\.0 g/dL
•6\) Platelet count above 70x103/mm3
•7\) Require an elective (non\-emergency), open (non\-laparoscopic; non\-endovascular) peripheral vascular surgical procedure.
•8\) Require one of peripheral vascular procedures listed below involving either an arterial patch angioplasty or an arterial anastomosis utilizing PTFE or Dacron grafts, according to the Investigator’s selection:
•Carotid endarterectomy requiring patch angioplasty
•Carotid\-subclavian bypass grafting

•1\)Have a pre\-operative international normalized ratio (INR) \= 2\.0
•2\)Have a pre\-operative aPTTratio \= 1\.5
•3\)Have a pre\-operative serum creatinine \> 2 times upper limit of normal (ULN) laboratory range
•4\)Have a pre\-operative AST or ALT \> 2\.5 times ULN laboratory range
•5\)Are undergoing a re\-operative procedure
•6\)Have an infection in the anatomic surgical area
•7\)Have a history of severe (e.g. anaphylactic) reactions to blood or any blood\-derived product
•8\)Are unwilling to receive blood products
•9\)Are unlikely to adhere to the protocol requirements, or to be cooperative during the study conduct
•10\)Have a positive bleeding history