At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis During Surgery in Paediatric Subjects
In Brief
A Phase 3 clinical trial evaluating Fibrin Sealant Grifols and EVICEL for Excessive Bleeding During Surgery. Completed, enrolled 186 participants across 40 sites in 10 countries.
Detailed 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).
Study Details
Timeline
Interventions
The FE Grifols solution was applied topically via drip or spray application.
The EVICEL solution was applied topically via drip or spray application.