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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 is a Phase 3 study that has completed, run by Instituto Grifols, S.A.. The registered enrollment target is 325 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01754480
The ClinicalTrials.gov registry entry for NCT01754480 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 325 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Instituto Grifols, S.A., which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fibrin Sealant Grifols is the first listed.
NCT01754480 reports 0 study locations.
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.
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