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FS Grifols in peripheral vascular surgery
NCT00684047Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2008
- Primary completion
- Mar 2014
- Countries
- 3
- Sponsor
- Grifols
- Modality
- Implantable Devices, Transdermal Patches, Recombinant Proteins and Enzymes
- Drugs
- VISTASEAL
- Conditions
- postoperative hemorrhage
01
Overview
Phase 3, randomised, single-blind trial of VISTASEAL in postoperative hemorrhage (3 arms), sponsored by Grifols. Primary endpoint: Time to Hemostasis at 10 minutes. Started Feb 2008; status: completed.
02
Design
3 arms- Study design
- RandomizedSingle-blind
FS Grifols Preliminary Part (I)
Open label administration of FS Grifols
FS Grifols Primary Part (II)
Single-blind, randomized FS Grifols
Manual Compression Primary Part (II)
Single-blind, randomized Manual Compression
03
Who it enrols
Patients undergoing elective open peripheral vascular surgery with mild to moderate bleeding at a target site, excluding those with coagulopathy or infection.
04
Endpoints
Primary
Time to Hemostasis
Secondary
Proportions of Subjects Achieving Hemostasis
Prevalence of Treatment Failures
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