Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Instituto Grifols, S.A.. The registered enrollment target is 186 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03461406
The ClinicalTrials.gov registry entry for NCT03461406 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 186 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.
NCT03461406 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.