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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier:
NCT00684047
First received: May 20, 2008
Last updated: December 17, 2015
Last verified: December 2015
  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
Procedure: Manual Compression
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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: No ]
    The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved.


Secondary Outcome Measures:
  • Proportions of Subjects Achieving Hemostasis [ Time Frame: 10 minutes from the start of treatment application at the target bleeding site ] [ Designated as safety issue: No ]
    The cumulative proportions of subjects who achieved hemostasis during the 10- minute observation period in Primary Part (II)

  • Prevalence of Treatment Failures [ Time Frame: 10 minutes from the start of treatment application at the target bleeding site ] [ Designated as safety issue: No ]
    The cumulative proportions of subjects who did not achieve hemostasis during the 10- minute observation period in Primary Part (II)


Enrollment: 239
Study Start Date: February 2008
Study Completion Date: May 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FS Grifols Preliminary Part (I)
Open label administration of FS Grifols to all subjects
Biological: FS Grifols
Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I)
Experimental: FS Grifols Primary Part (II)
Single-blind, randomized (2:1)
Biological: FS Grifols
Fibrin Sealant Grifols (FS Grifols). Primary Part (II)
Active Comparator: Manual Compression Primary Part (II)
Single-blind, randomized (2:1)
Procedure: Manual Compression
Manual Compression. Primary Part (II)

Detailed Description:
The trial consisted of 2 parts: a Preliminary Part (I) and a Primary Part (II). All subjects enrolled in Preliminary Part (I) were treated with FS Grifols. Subjects in Primary Part (II) were randomly allocated in a 2:1 ratio to treatment with FS Grifols or manual compression. The objectives of the study were to evaluate the hemostasis effectiveness of FS Grifols in peripheral vascular surgery and to assess clinical safety, viral safety, and immunogenicity.
  Eligibility

Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
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 (must be at least 18 years of age in Spain and United Kingdom)
  • Require an elective (non-emergency), open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure
  • Have hemoglobin ≥ 9.0 g/dL
  • Have platelet count > 70 x 10^3/mm^3
  • Required one peripheral vascular procedure involving either an arterial patch angioplasty or an arterial anastomosis utilizing polytetrafluoroethylene or Dacron grafts, according to the Investigator's (the surgeon's) selection:

    1. Carotid endarterectomy requiring patch angioplasty
    2. Carotid-subclavian bypass grafting
    3. Axillo-femoral bypass grafting
    4. Abdominal aortic aneurysm resection and graft replacement
    5. Aorto-mesenteric bypass grafting
    6. Aorto-celiac bypass grafting
    7. Aorto-uni-iliac bypass grafting
    8. Aorto-bi-iliac bypass grafting
    9. Aorto-uni-femoral bypass grafting
    10. Aorto-bi-femoral bypass grafting
    11. Iliac aneurysm resection and graft replacement
    12. Femoral aneurysm resection and graft replacement
    13. Femoral-femoral bypass grafting
    14. Femoral-popliteal bypass grafting
    15. Renal arterial revascularization (bypass grafting)
    16. Renal arterial revascularization (endarterectomy with patch angioplasty)
    17. Popliteal artery revascularization (bypass grafting)
    18. Popliteal artery revascularization (endarterectomy with patch angioplasty)
    19. Femoral endarterectomy with patch angioplasty
    20. Ilio-femoral bypass grafting
  • Intra-operative inclusion criterion:

    • A Target bleeding site (TBS)can be identified according to the Investigator's judgment, and the TBS has a mild or moderate arterial bleeding according to the Investigator's judgment

Exclusion Criteria:

  • Weighed < 20 kg
  • Have a pre-operative (at Baseline Assessments) international normalized ratio ≥ 2.0
  • Have a pre-operative (at Baseline Assessments) activated partial thromboplastin time ratio ≥ 1.5
  • Have a pre-operative (at Baseline Assessments) serum creatinine > 2 times the upper limit of the normal range
  • Were undergoing a re-operative procedure on same arterial patch angioplasty or arterial anastomosis
  • Have an infection in the anatomical surgical area
  • Have a history of severe (e.g., anaphylactic) reactions to blood or any blood derived product
  • Unwilling to receive blood products
  • Have positive bleeding history
  • Female who was pregnant or nursing
  • Are known to abuse alcohol, opiates, psychotropic agents or other chemicals or drugs, or have done so within 12 months to the screening visit.
  • Are currently participating in another investigational drug or device clinical study, or have participated within 3 months to the screening visit.
  • Were previously included in this clinical trial (protocol number IG402)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
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 Clinic i Provincial
Barcelona, Spain, 08036
Hospital de Sabadell
Barcelona, Spain, 08208
Hospital Son Espases
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 ORE
Sponsors and Collaborators
Instituto Grifols, S.A.
Investigators
Study Director: Louis Kozloff, MD Independent
  More Information

Responsible Party: Instituto Grifols, S.A.
ClinicalTrials.gov Identifier: NCT00684047     History of Changes
Other Study ID Numbers: IG402 
Study First Received: May 20, 2008
Results First Received: September 25, 2015
Last Updated: December 17, 2015
Health Authority: Canada: Health Canada
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Hemostatics
Fibrin Tissue Adhesive
Coagulants

ClinicalTrials.gov processed this record on July 25, 2016