A Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) during Parenchymous Tissue Open Surgeries
Study to evaluate the safety and effectiveness of Fibrin sealant during open surgeries
Sponsor: Instituto Grifols S.A.
Enrolling: Male and Female Patients
Study Length: 7 Months
Clinic Visits: 9
IRB Number: AAAL7900
U.S. Govt. ID: NCT01754480
Contact: Theresa Lukose: 212-305-3839 / tt2103@columbia.edu
Additional Study Information: The purpose of this study is to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during parenchyomous tissue open surgical procedures. Baseline assessments will be performed within 24 hours prior to the scheduled surgery. There will be a physical assessment and a blood draw at the first study visit. Subjects will be randomly assigned to one of two treatment groups FS Grifols or Surgicel.
This study is closed
Investigator
Tomoaki Kato, MD
Do You Qualify?
Will you be a hepatic resection? Yes No
Will you be undergoing a liver transplant during the resection? Yes No
Are you allergic to blood or blood-derived products? Yes No
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For more information, please contact:
Theresa Lukose
tt2103@columbia.edu
212-305-3839