Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries
Public ClinicalTrials.gov record NCT01754480. 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.
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 Parenchymous Tissue Open Surgeries
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to demonstrate that Fibrin Sealant Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of Fibrin Sealant Grifols and to assess safety and a Primary Part (II) to assess the safety and efficacy of Fibrin Sealant Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either Fibrin Sealant Grifols or Surgicel.
Study identification
- NCT ID
- NCT01754480
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 325 participants
Conditions and interventions
Conditions
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
- Mar 2013 (Type not available)
- Primary completion
- Dec 2015 (Actual)
- Completion
- Dec 2015 (Actual)
- Last update posted
- Feb 8, 2017
2013 – 2015
United States locations
- U.S. sites
- 26
- U.S. states
- 20
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 224 | Loma Linda | California | 92354 | — |
| 214 | Los Angeles | California | 90033 | — |
| 213 | New Haven | Connecticut | 06520 | — |
| 223 | Augusta | Georgia | 30912 | — |
| 228 | Chicago | Illinois | 60611 | — |
| 227 | Goshen | Indiana | 46526 | — |
| 207 | Louisville | Kentucky | 40202 | — |
| 220 | New Orleans | Louisiana | 70112 | — |
| 229 | Bethesda | Maryland | 20889 | — |
| 201 | St Louis | Missouri | 63110 | — |
| 231 | Las Vegas | Nevada | 89102 | — |
| 200 | Albany | New York | 12208 | — |
| 211 | New York | New York | 10029 | — |
| 212 | New York | New York | 10032 | — |
| 230 | Charlotte | North Carolina | 28204 | — |
| 233 | Cincinnati | Ohio | 45219 | — |
| 400 | Hershey | Pennsylvania | 17033 | — |
| 218 | Philadelphia | Pennsylvania | 19102 | — |
| 204 | Philadelphia | Pennsylvania | 19107 | — |
| 205 | Charleston | South Carolina | 29425 | — |
| 217 | Memphis | Tennessee | 38104 | — |
| 206 | Nashville | Tennessee | 37232-7610 | — |
| 216, 219 | Houston | Texas | 77030 | — |
| 232 | Salt Lake City | Utah | 84132 | — |
| 226 | Charlottesville | Virginia | 22908 | — |
| 202 | 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 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01754480, 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 Feb 8, 2017 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01754480 live on ClinicalTrials.gov.