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

NCT03461406 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2023-04-14

Study results available
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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).

Conditions

  • Excessive Bleeding During Surgery

Interventions

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.

Sponsors & Collaborators

  • Instituto Grifols, S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-18
Primary Completion
2022-04-15
Completion
2022-05-20
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • France
  • Germany
  • Hungary
  • Romania
  • Serbia
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03461406 on ClinicalTrials.gov