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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: Completed Phase 3 study, sponsored by Instituto Grifols, S.A..
NCT01662856 is a Phase 3 study that has completed, run by Instituto Grifols, S.A.. The registered enrollment target is 225 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
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
- PROCEDURE Manual Compression
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
What the finished NCT01662856 record still lists
NCT01662856 is an interventional study that assigns participants to a tested intervention. The registered 225 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 (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Fibrin Sealant Grifols is the first listed.
NCT01662856 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01662856's enrollment target sits among peer trials
225 1311th of 2000 higher than 684 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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