The purpose of this study is to evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.
The trial consisted of 2 parts: a Preliminary Part (I) and a Primary Part (II). All subjects enrolled in Preliminary Part (I) were treated with FS Grifols. Subjects in Primary Part (II) were randomly allocated in a 2:1 ratio to treatment with FS Grifols or manual compression. The objectives of the study were to evaluate the hemostasis effectiveness of FS Grifols in peripheral vascular surgery and to assess clinical safety, viral safety, and immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
239
Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I)
Fibrin Sealant Grifols (FS Grifols). Primary Part (II)
Manual Compression. Primary Part (II)
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Schulich School of Medicine, London Health Sciences Center
London, Ontario, Canada
The Primary Efficacy Endpoint is Time to Hemostasis.
The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved.
Time frame: The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10-minute observational period when the hemostasis has not yet been achieved.
Proportions of Subjects Achieving Hemostasis
The cumulative proportions of subjects who achieved hemostasis during the 10- minute observation period in Primary Part (II)
Time frame: 10 minutes from the start of treatment application at the target bleeding site
Prevalence of Treatment Failures
The cumulative proportions of subjects who did not achieve hemostasis during the 10- minute observation period in Primary Part (II)
Time frame: 10 minutes from the start of treatment application at the target bleeding site
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