A Study of Fibrocaps™ in Surgical Bleeding
Public ClinicalTrials.gov record NCT01527357. 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 Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis. The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.
Study identification
- NCT ID
- NCT01527357
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 721 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- May 21, 2012 (Actual)
- Primary completion
- Apr 24, 2013 (Actual)
- Completion
- Jun 1, 2013 (Actual)
- Last update posted
- Dec 18, 2019
2012 – 2013
United States locations
- U.S. sites
- 29
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Cardio-Thoracic Surgeons, PC | Birmingham | Alabama | 35242 | — |
| University of Southern California, Keck School of Medicine | Los Angeles | California | 90033 | — |
| University of Southern California/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Vascular Interventional Specialists of Orange County | Orange | California | 92868 | — |
| Lotus Clinical Research, LLC | Pasadena | California | 91105 | — |
| Boulder Neurological Institute | Boulder | Colorado | 80304 | — |
| Spine Colorado | Durango | Colorado | 81303 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| NorthShore University HealthSystem | Skokie | Illinois | 60077 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | — |
| Indiana Spine Group | Carmel | Indiana | 46032 | — |
| Bluegrass Orthopedics | Lexington | Kentucky | 40509 | — |
| Lahey Clinic Medical Center | Burlington | Massachusetts | 01805 | — |
| Borgess Research Institute | Kalamazoo | Michigan | 49048 | — |
| Beaumont Health System | Royal Oak | Michigan | 48073 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| William Muir MD Spine Surgery | Las Vegas | Nevada | 89144 | — |
| New York-Presbyterian Hospital/Columbia University | New York | New York | 100032 | — |
| Duke University Hospital Medical Center | Durham | North Carolina | 27710 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| The University of Oklahoma - Tulsa | Tulsa | Oklahoma | 74135 | — |
| Oregon Health & Science University Hospital & Clinics | Portland | Oregon | 97239-3098 | — |
| University of North Texas Health Sciences Center | Fort Worth | Texas | 76107 | — |
| Physician's Research Options | Sandy City | Utah | 84070 | — |
| Overlake Hospital Medical Center | Bellevue | Washington | 98004 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| Northwest Orthopaedic Specialists, P.S. | Spokane | Washington | 99208 | — |
| Multicare Neuroscience Center of Washington | Tacoma | Washington | 98405 | — |
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 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01527357, 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 Dec 18, 2019 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01527357 live on ClinicalTrials.gov.