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NCT03461406 · ClinicalTrials.gov registry record · Phase 3
A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants
A Phase 3 study, sponsored by Instituto Grifols, S.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 186
- Enrollment target
NCT03461406: Completed Phase 3 study, sponsored by Instituto Grifols, S.A..
NCT03461406 is a Phase 3 study that has completed, run by Instituto Grifols, S.A.. The registered enrollment target is 186 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03461406, a Phase 3 study, has completed, sponsored by Instituto Grifols, S.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 186 participants
- Enrollment target
Study Summary
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).
Primary Outcome
Hemostasis is defined as Grade 0 bleeding per 5-point validated bleeding severity scale (0=no bleeding and 4=Unidentified or inaccessible spurting or gush) at the target bleeding site (TBS) according to the investigator's (surgeon's) judgment, so that the surgical closure of the exposed field could begin.
Interventions
- BIOLOGICAL Fibrin Sealant Grifols
- BIOLOGICAL EVICEL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2019-01-18 |
| Est. Completion | 2022-05-20 |
| Phase | Phase 3 |
What the finished NCT03461406 record still lists
NCT03461406 is an interventional study that assigns participants to a tested intervention. The registered 186 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 (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Fibrin Sealant Grifols is the first listed.
NCT03461406 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03461406 about?
NCT03461406 is a clinical study titled "A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants". 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 completio...
What is the current status of trial NCT03461406?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 186 participants. The study started on 2019-01-18. Estimated completion is 2022-05-20.
What interventions are being tested in trial NCT03461406?
The interventions under investigation include: Fibrin Sealant Grifols (BIOLOGICAL), EVICEL (BIOLOGICAL).
Who is sponsoring clinical trial NCT03461406?
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 NCT03461406's enrollment target sits among peer trials
186 1412th of 2000 higher than 584 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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