NCT03461406

A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Instituto Grifols, S.A. · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a prospective, randomized, active-controlled, single-blind, parallel group clinical trial to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during surgery. Approximately 172 pediatric participants will be enrolled and will be randomly allocated in a 1:1 ratio into 1 of 2 treatment groups: FS Grifols or EVICEL. Enrollment will be monitored by surgery type to ensure at least 50% of the surgical procedures are hepatic. A specific bleeding site will be defined as the TBS when it is determined by the investigator (the surgeon) that control of bleeding by conventional surgical techniques (including suture, ligature, and cautery) is ineffective or impractical and requires an adjunct treatment to achieve hemostasis. When the TBS is identified, the investigator will record the precise anatomical location of the TBS, rate the intensity of the bleeding at the TBS (Grade 1-4 according to a 5-point validated bleeding severity scale), and record the size of the approximate bleeding surface, (small, medium, and large). For soft tissue surgery only, the investigator will also record the type of soft tissue (ie, fat, muscle, or connective tissue). In this clinical trial, only participants with a TBS with bleeding of Grade 1 (mild) or Grade 2 (moderate) intensity will be enrolled. This study includes a Screening Visit to determine participant eligibility, a Baseline Visit, the Surgical Procedure (Day 1), and Post-operative assessments at Days 1, 4, and 30. The total duration of a participant's participation in this study is expected to be no longer than 2 months from the Screening Visit to the Post-operative Day 30 Visit.

Conditions

• Excessive Bleeding During Surgery

Interventions

Type	Name	Description
BIOLOGICAL	Fibrin Sealant Grifols	The FE Grifols solution was applied topically via drip or spray application.
BIOLOGICAL	EVICEL	The EVICEL solution was applied topically via drip or spray application.

Timeline

• Start date: 2019-01-18
• Primary completion: 2022-04-15
• Completion: 2022-05-20
• First posted: 2018-03-12
• Last updated: 2023-04-14
• Results posted: 2023-04-07

Locations

40 sites across 10 countries: United States, Bulgaria, Canada, France, Germany, Hungary, Romania, Serbia, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study