Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Grifols Biologicals Inc.
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier:
NCT01662856
First received: August 7, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to demonstrate that the application of Fibrin Sealant (FS) Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression (MC). This study has a Preliminary Part (I) in which all subjects are treated with FS Grifols and a Primary Part (II) in which subjects will be randomized in a 2:1 ratio to either FS Grifols or MC.


Condition Intervention Phase
Peripheral Vascular Surgical Bleeding
Biological: Fibrin Sealant Grifols
Procedure: Manual Compression
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:
  • Proportion of subjects achieving hemostasis within four minutes after treatment start [ Time Frame: From start of treatment until 4 minutes after treatment start ] [ Designated as safety issue: No ]
    Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.


Secondary Outcome Measures:
  • Time to hemostasis [ Time Frame: From start of treatment until 10 minutes after treatment start ] [ Designated as safety issue: No ]
    Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.

  • Treatment Failures [ Time Frame: From start of treatment until 10 minutes after treatment start ] [ Designated as safety issue: Yes ]
    Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment.

  • Adverse Events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Non-serious and serious adverse events

  • Cumulative proportion of subjects having achieved hemostasis at the target bleeding site by specified time points [ Time Frame: From start of treatment until 10 minutes after treatment start ] [ Designated as safety issue: No ]

    Cumulative proportion of subjects having achieved hemostasis by each of the following timepoints:

    • At 5 minutes following start of study treatment
    • At 7 minutes following start of study treatment
    • At 10 minutes following start of study treatment


Estimated Enrollment: 237
Study Start Date: August 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fibrin Sealant Grifols (FS)
Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Biological: Fibrin Sealant Grifols
Combination of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Active Comparator: Manual Compression
Direct manual compression of target bleeding site with gauze/laparotomy pads.
Procedure: Manual Compression
Direct manual compression of target bleeding site with gauze/laparotomy pads.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemoglobin (Hgb) ≥ 9.0 g/dL at Baseline (within 24 hours prior to surgical procedure)
  • Require elective (non-emergency), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgery
  • Require one of the following peripheral vascular procedures involving proximal end-to-side arterial anastomosis utilizing coated or uncoated Polytetrafluoroethylene grafts: a) Femoral-femoral bypass grafting, b) Femoral-popliteal bypass grafting, c) Femoral-distal bypass grafting, d) Ilio-iliac bypass grafting, e) Ilio-femoral bypass grafting, f) Ilio-popliteal bypass grafting, g) Aorto-iliac bypass grafting, h) Aorto-femoral bypass grafting, i)Axillo-femoral bypass grafting, and j) Upper extremity vascular access for hemodialysis.
  • A target bleeding site can be identified.
  • Target bleeding site has moderate arterial bleeding.

Exclusion Criteria:

  • Undergoing a re-operative procedure.
  • Undergoing other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed).
  • Have an infection in the anatomic surgical area.
  • Have a history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
  • Have previous known sensitivity to any FS Grifols, heparin, or protamine component.
  • Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
  • Have undergone a therapeutic surgical procedure within 30 days from the screening visit
  • Target bleeding site cannot be identified
  • Target bleeding site has mild or severe arterial bleeding.
  • Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
  • Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria.
  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: NCT01662856

Contacts
Contact: Paul Pinciaro, PhD paul.pinciaro@grifols.com

  Show 26 Study Locations
Sponsors and Collaborators
Instituto Grifols, S.A.
  More Information

No publications provided

Responsible Party: Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier: NCT01662856     History of Changes
Other Study ID Numbers: IG1101
Study First Received: August 7, 2012
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Hungary: National Institute of Pharmacy
Serbia: Medicines and Medical Devices Agency

Keywords provided by Grifols Biologicals Inc.:
Peripheral Vascular Surgery
Fibrin Sealant
Polytetrafluoroethylene (PTFE) grafts

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

ClinicalTrials.gov processed this record on September 18, 2014