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

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

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:	225
Study Start Date:	August 2012
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 2014 (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.	Biological: Fibrin Sealant Grifols Combination of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder.
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
Require elective (non-emergency), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgery
Require one of the following peripheral vascular procedures involving end-to-side arterial anastomosis utilizing 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, and g) 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.
Known (documented) previous exposure to thrombin-containing products.
Females who are pregnant or nursing a child.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662856

Contacts

Contact: Paul Pinciaro, PhD

paul.pinciaro@grifols.com

Show 21 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:	March 18, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Grifols Biologicals Inc.:

Peripheral Vascular Surgery
Fibrin Sealant
Polytetrafluoroethylene (PTFE) grafts

Additional relevant MeSH terms:

Hemorrhage
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics

Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013