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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier:
NCT00684047
First received: May 20, 2008
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Target Bleeding Site During Peripheral Vascular Surgery
Biological: FS Grifols
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Single-blind, Randomized, Phase II/III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Peripheral Vascular Surgery

Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:
  • The primary efficacy endpoint is time to hemostasis. [ Time Frame: The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10 minute observational period when the hemostasis has not yet been achieved. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The first secondary efficacy endpoint is a cumulative proportion of subjects achieving hemostasis at the target bleeding site (TBS) at several hemostatic time categories (HTCs). The second secondary efficacy endpoint is prevalence of treatment failures. [ Time Frame: HTC less than or equal to 3, HTC greater than 3 but less than or equal to 4, HTC greater than 4 but less than or equal to 5, HTC greater than 5 but less than or equal to 7, and HTC greater than 7 but less than or equal to 10. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 228
Study Start Date: February 2008
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FS Grifols Biological: FS Grifols
Fibrin Sealant Grifols (FS Grifols).

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are male or female
  • Must be at least 3 years of age with no upper age limit
  • Require an elective (non-emergency), open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure

Exclusion Criteria:

  • Have a pre-operative (at Baseline Assessments) INR ≥ 2.0
  • Have a pre-operative (at Baseline Assessments) aPTT ratio ≥ 1.5
  • Have a pre-operative (at Baseline Assessments) serum creatinine > 2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684047

Locations
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Schulich School of Medicine, London Health Sciences Center
London, Ontario, Canada, N6A 5W9
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain, 28905
Hospital de Sabadell
Barcelona, Spain, 08208
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital Son Dureta
Palma de Mallorca, Spain, 07014
Clinica Universitaria de Navarra
Pamplona, Spain, 31008
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
United Kingdom
Queen Elizabeth Hospital Birmingham
Edgbaston, Birmingham, United Kingdom, B15 2WB
Frimley Park Hospital
Frimley, Surrey, United Kingdom, GU16 7UJ
Doncaster Royal Infirmary Hospital
Doncaster, United Kingdom, DN2 5LT
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Hull Royal Infirmary
Hull, United Kingdom, HU3 2JZ
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
St. George's Hospital
Tooting, United Kingdom, SW17 OQT
Sponsors and Collaborators
Instituto Grifols, S.A.
  More Information

No publications provided

Responsible Party: Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier: NCT00684047     History of Changes
Other Study ID Numbers: IG402
Study First Received: May 20, 2008
Last Updated: November 8, 2013
Health Authority: Canada: Health Canada

Keywords provided by Grifols Biologicals Inc.:
Fibrin Sealant
Hemostasis
Peripheral Vascular Surgery

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014