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Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis

NCT00684047 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2016-01-25

Study results available
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Summary

The purpose of this study is to evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.

Conditions

  • Target Bleeding Site During Peripheral Vascular Surgery

Interventions

BIOLOGICAL

FS Grifols

Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I)

BIOLOGICAL

FS Grifols

Fibrin Sealant Grifols (FS Grifols). Primary Part (II)

PROCEDURE

Manual Compression

Manual Compression. Primary Part (II)

Sponsors & Collaborators

  • Instituto Grifols, S.A.

    lead INDUSTRY

Principal Investigators

  • Louis Kozloff, MD · Independent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2014-03-31
Completion
2014-05-31

Countries

  • Canada
  • Spain
  • 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 NCT00684047 on ClinicalTrials.gov