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NCT01754480 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries
A Phase 3 study, sponsored by Instituto Grifols, S.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 325
- Enrollment target
NCT01754480: Completed Phase 3 study, sponsored by Instituto Grifols, S.A..
NCT01754480 is a Phase 3 study that has completed, run by Instituto Grifols, S.A.. The registered enrollment target is 325 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01754480, a Phase 3 study, has completed, sponsored by Instituto Grifols, S.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 325 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
Interventions
- BIOLOGICAL Fibrin Sealant Grifols
- DEVICE Surgicel®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2013-03 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
What the finished NCT01754480 record still lists
NCT01754480 is an interventional study that assigns participants to a tested intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Fibrin Sealant Grifols is the first listed.
NCT01754480 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01754480 about?
NCT01754480 is a clinical study titled "Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries". 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 Gr...
What is the current status of trial NCT01754480?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 325 participants. The study started on 2013-03. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01754480?
The interventions under investigation include: Fibrin Sealant Grifols (BIOLOGICAL), Surgicel® (DEVICE).
Who is sponsoring clinical trial NCT01754480?
This trial is sponsored by Instituto Grifols, S.A., which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01754480's enrollment target sits among peer trials
325 1076th of 2000 higher than 922 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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