A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants
Public ClinicalTrials.gov record NCT03461406. 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, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis During Surgery in Paediatric Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of participants achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment application (TStart) with no occurrence of rebleeding until the completion of the surgical closure by layers of the exposed surgical field containing the TBS (TClosure).
Study identification
- NCT ID
- NCT03461406
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 186 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 17 Years
- 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
- Jan 17, 2019
- Primary completion
- Apr 14, 2022
- Completion
- May 19, 2022
- Last update posted
- Apr 13, 2023
2019 – 2022
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lurie Childrens Hospital of Chicago | Chicago | Illinois | 60611 | — |
| University of Michigan | Michigan Center | Michigan | 48109 | — |
| The Urological Institute of Northeastern New York | Albany | New York | 12208 | — |
| Columbia Medical Center | New York | New York | 10032 | — |
| St. Christophers Hospital | Philadelphia | Pennsylvania | 19134 | — |
| MUSC Health-Children's Hospital | Charleston | South Carolina | 29425 | — |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38163 | — |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | — |
| El Paso Childrens Hospital | El Paso | Texas | 79905 | — |
| Memorial Hermann Memorial City | Houston | Texas | 77024 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
| Carilion Children's Pediatric Surgery | Roanoke | Virginia | 24013 | — |
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 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03461406, 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 13, 2023 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03461406 live on ClinicalTrials.gov.