Clinical trial NCT01662856: Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vascular Surgical Bleeding
Keywords: Vascular Surgery
Fibrin Sealant
Polytetrafluoroethylene (PTFE) grafts
Lead sponsor: Grifols Biologicals, LLC
Sponsor class: INDUSTRY
First posted: 2012-08-10
Enrollment: 225
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria.

Primary outcomes:
measure: Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
timeFrame: From start of treatment until 4 minutes after treatment start
Secondary outcomes:
measure: Time to Hemostasis (TTH)
timeFrame: From start of treatment until 10 minutes after treatment start
measure: Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
timeFrame: From start of treatment until 10 minutes after treatment start
measure: Prevalence of Treatment Failures
timeFrame: From start of treatment until 10 minutes after treatment start
Other outcomes:
Locations:
city: Florence
country: United States
facility: 407
state: Alabama
city: Palo Alto
country: United States
facility: 125
state: California
city: San Diego
country: United States
facility: 119
state: California
city: Jacksonville
country: United States
facility: 149
state: Florida
city: Jacksonville
country: United States
facility: 148
state: Florida
city: Tampa
country: United States
facility: 137
state: Florida
city: Atlanta
country: United States
facility: 140
state: Georgia
city: Iowa City
country: United States
facility: 114
state: Iowa
city: Lexington
country: United States
facility: 110
state: Kentucky
city: Baton Rouge
country: United States
facility: 146
state: Louisiana
city: New Orleans
country: United States
facility: 132
state: Louisiana
city: Baltimore
country: United States
facility: 129
state: Maryland
city: Bethesda
country: United States
facility: 135
state: Maryland
city: Boston
country: United States
facility: 102
state: Massachusetts
city: Bronx
country: United States
facility: 142
state: New York
city: Manhasset
country: United States
facility: 406
state: New York
city: Stony Brook
country: United States
facility: 113
state: New York
city: Dayton
country: United States
facility: 409
state: Ohio
city: Toledo
country: United States
facility: 104
state: Ohio
city: Pittsburgh
country: United States
facility: 100, 128
state: Pennsylvania
city: West Reading
country: United States
facility: 115
state: Pennsylvania
city: Fort Worth
country: United States
facility: 147
state: Texas
city: Houston
country: United States
facility: 402
state: Texas
city: Salt Lake City
country: United States
facility: 139
state: Utah
city: Seattle
country: United States
facility: 103
state: Washington
city: Tacoma
country: United States
facility: 138
state: Washington
city: Madison
country: United States
facility: 111
state: Wisconsin
city: Miskolc
country: Hungary
facility: 501
city: Pecs
country: Hungary
facility: 500
city: Veszprém
country: Hungary
facility: 502
city: Novosibirsk
country: Russian Federation
facility: 540
city: Rostov-on-Don
country: Russian Federation
facility: 542
city: Saint-Petersburg
country: Russian Federation
facility: 541
city: Saint-Petersburg
country: Russian Federation
facility: 543
city: Saint-Petersburg
country: Russian Federation
facility: 544
city: Belgrade
country: Serbia
facility: 523
city: Belgrade
country: Serbia
facility: 521
city: Novi Sad
country: Serbia
facility: 522,524
Study officials:
References: