Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery

Completed · Phase 3

Conditions studied: Vascular Surgical Bleeding

In brief

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.

Key facts

Study ID: NCT01662856
Run by: Instituto Grifols, S.A.
People needed: 225
Starts: 2012-08-01
Expected to finish: 2015-12-01
Last updated by the study team: 2017-04-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

407 — Florence, Alabama, United States
125 — Palo Alto, California, United States
119 — San Diego, California, United States
149 — Jacksonville, Florida, United States
148 — Jacksonville, Florida, United States
137 — Tampa, Florida, United States
140 — Atlanta, Georgia, United States
114 — Iowa City, Iowa, United States
110 — Lexington, Kentucky, United States
146 — Baton Rouge, Louisiana, United States
132 — New Orleans, Louisiana, United States
129 — Baltimore, Maryland, United States
135 — Bethesda, Maryland, United States
102 — Boston, Massachusetts, United States
406 — Manhasset, New York, United States
113 — Stony Brook, New York, United States
142 — The Bronx, New York, United States
409 — Dayton, Ohio, United States
104 — Toledo, Ohio, United States
100, 128 — Pittsburgh, Pennsylvania, United States
115 — West Reading, Pennsylvania, United States
147 — Fort Worth, Texas, United States
402 — Houston, Texas, United States
139 — Salt Lake City, Utah, United States
103 — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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