Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery
A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Peripheral Vascular Surgery
1 other identifier
interventional
225
4 countries
38
Brief Summary
The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression. This study has a Preliminary Part (I) in which all subjects are treated with Fibrin Sealant Grifols and a Primary Part (II) in which subjects are randomized in a 2:1 ratio to either Fibrin Sealant Grifols or manual compression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2012
Typical duration for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 7, 2012
CompletedFirst Posted
Study publicly available on registry
August 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
April 6, 2017
CompletedApril 6, 2017
February 1, 2017
3.3 years
August 7, 2012
December 16, 2016
February 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
From start of treatment until 4 minutes after treatment start
Secondary Outcomes (3)
Time to Hemostasis (TTH)
From start of treatment until 10 minutes after treatment start
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
From start of treatment until 10 minutes after treatment start
Prevalence of Treatment Failures
From start of treatment until 10 minutes after treatment start
Study Arms (2)
Fibrin Sealant Grifols
EXPERIMENTALFibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Manual Compression
ACTIVE COMPARATORDirect manual compression of target bleeding site with gauze/laparotomy pads.
Interventions
Combination of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Direct manual compression of target bleeding site with gauze/laparotomy pads.
Eligibility Criteria
You may qualify if:
- Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
- Require elective (non-emergency), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgery.
- Require one of the following peripheral vascular procedures involving proximal end-to-side arterial anastomosis utilizing coated or uncoated Polytetrafluoroethylene grafts: a) Femoral-femoral bypass grafting, b) Femoral-popliteal bypass grafting, c) Femoral-distal bypass grafting, d) Ilio-iliac bypass grafting, e) Ilio-femoral bypass grafting, f) Ilio-popliteal bypass grafting, g) Aorto-iliac bypass grafting, h) Aorto-femoral bypass grafting, i)Axillo-femoral bypass grafting, and j) Upper extremity vascular access for hemodialysis.
- A target bleeding site can be identified.
- Target bleeding site has moderate arterial bleeding.
You may not qualify if:
- Undergoing a re-operative procedure.
- Undergoing other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed).
- Have an infection in the anatomic surgical area.
- Have a history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
- Have previous known sensitivity to any Fibrin Sealant Grifols, heparin, or protamine component.
- Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
- Have undergone a therapeutic surgical procedure within 30 days from the screening visit.
- Target bleeding site cannot be identified.
- Target bleeding site has mild or severe arterial bleeding.
- Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
407
Florence, Alabama, 35630, United States
125
Palo Alto, California, 94304, United States
119
San Diego, California, 92120, United States
149
Jacksonville, Florida, 32207, United States
148
Jacksonville, Florida, 32216, United States
137
Tampa, Florida, 33606, United States
140
Atlanta, Georgia, 30303, United States
114
Iowa City, Iowa, 52242, United States
110
Lexington, Kentucky, 40536, United States
146
Baton Rouge, Louisiana, 70809, United States
132
New Orleans, Louisiana, 70112, United States
129
Baltimore, Maryland, 21201, United States
135
Bethesda, Maryland, 20889, United States
102
Boston, Massachusetts, 02118, United States
406
Manhasset, New York, 11030, United States
113
Stony Brook, New York, 11794, United States
142
The Bronx, New York, 10467-2401, United States
409
Dayton, Ohio, 45409, United States
104
Toledo, Ohio, 43606, United States
100, 128
Pittsburgh, Pennsylvania, 15212, United States
115
West Reading, Pennsylvania, 19611, United States
147
Fort Worth, Texas, 76107, United States
402
Houston, Texas, 77024, United States
139
Salt Lake City, Utah, 84132-3201, United States
103
Seattle, Washington, 98104, United States
138
Tacoma, Washington, 98431, United States
111
Madison, Wisconsin, 53792, United States
501
Miskolc, 03526, Hungary
500
Pécs, 07623, Hungary
502
Veszprém, 8200, Hungary
540
Novosibirsk, 630055, Russia
542
Rostov-on-Don, 344022, Russia
541
Saint Petersburg, 194354, Russia
543
Saint Petersburg, 195271, Russia
544
Saint Petersburg, 197374, Russia
523
Belgrade, 11000, Serbia
521
Belgrade, 11040, Serbia
522,524
Novi Sad, 21000, Serbia
Related Publications (1)
Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.
PMID: 38695613DERIVED
Results Point of Contact
- Title
- Henry Li, PhD
- Organization
- Grifols Therapeutics Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2012
First Posted
August 10, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
April 6, 2017
Results First Posted
April 6, 2017
Record last verified: 2017-02