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NCT01662856 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery
A Phase 3 study, sponsored by Instituto Grifols, S.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
NCT01662856 is a Phase 3 study that has completed, run by Instituto Grifols, S.A.. The registered enrollment target is 225 participants.
The verdict
NCT01662856, a Phase 3 study, has completed, sponsored by Instituto Grifols, S.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression. This study has a Preliminary Part (I) in which all subjects are treated with Fibrin Sealant Grifols and a Primary Part (II) in which subjects are randomized in a 2:1 ratio to either Fibrin Sealant Grifols or manual compression.
Interventions
- BIOLOGICAL Fibrin Sealant Grifols
- PROCEDURE Manual Compression
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01662856
The ClinicalTrials.gov registry entry for NCT01662856 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 225 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.
NCT01662856 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01662856 about?
NCT01662856 is a clinical study titled "Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery". The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression. Th...
What is the current status of trial NCT01662856?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2012-08. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01662856?
The interventions under investigation include: Fibrin Sealant Grifols (BIOLOGICAL), Manual Compression (PROCEDURE).
Who is sponsoring clinical trial NCT01662856?
This trial is sponsored by Instituto Grifols, S.A., which has 10 total clinical trials registered on ClinicalTrials.gov.
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