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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01662856

Public ClinicalTrials.gov record NCT01662856. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 11:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01662856
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Instituto Grifols, S.A.
Industry
Enrollment
225 participants

Conditions and interventions

Interventions

Biological · Procedure

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2012 (Type not available)
Primary completion
Dec 2015 (Actual)
Completion
Dec 2015 (Actual)
Last update posted
Apr 6, 2017

2012 – 2015

United States locations

U.S. sites
27
U.S. states
16
U.S. cities
26
Facility City State ZIP Site status
407 Florence Alabama 35630 —
125 Palo Alto California 94304 —
119 San Diego California 92120 —
149 Jacksonville Florida 32207 —
148 Jacksonville Florida 32216 —
137 Tampa Florida 33606 —
140 Atlanta Georgia 30303 —
114 Iowa City Iowa 52242 —
110 Lexington Kentucky 40536 —
146 Baton Rouge Louisiana 70809 —
132 New Orleans Louisiana 70112 —
129 Baltimore Maryland 21201 —
135 Bethesda Maryland 20889 —
102 Boston Massachusetts 02118 —
406 Manhasset New York 11030 —
113 Stony Brook New York 11794 —
142 The Bronx New York 10467-2401 —
409 Dayton Ohio 45409 —
104 Toledo Ohio 43606 —
100, 128 Pittsburgh Pennsylvania 15212 —
115 West Reading Pennsylvania 19611 —
147 Fort Worth Texas 76107 —
402 Houston Texas 77024 —
139 Salt Lake City Utah 84132-3201 —
103 Seattle Washington 98104 —
138 Tacoma Washington 98431 —
111 Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01662856, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 6, 2017 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01662856 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →