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The Evicel Post-Authorization Surveillance Study

This study has been completed.
Sponsor:
Collaborator:
OMRIX Biopharmaceuticals
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01158261
First received: July 6, 2010
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.


Condition Intervention
Peripheral Vascular Disease
Hemorrhage
Biological: EVICEL ™ Fibrin Sealant (Human)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Single-Arm, Observational, Non-interventional Study for EVICEL ™ Fibrin Sealant (Human) When Used as an Adjunct to Haemostasis in Vascular Surgery

Resource links provided by NLM:


Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Specific safety parameters [ Time Frame: Up to 4-weeks post-operatively ] [ Designated as safety issue: Yes ]
    • Incidence of graft occlusion
    • Incidence of adverse events potentially related to non-graft thrombotic events
    • Incidence of bleeding events


Enrollment: 300
Study Start Date: June 2010
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Vascular Surgery Subjects Biological: EVICEL ™ Fibrin Sealant (Human)
Commercial Evicel
Other Name: Fibrin Sealant (Human)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects requiring elective vascular procedures

Criteria

Inclusion Criteria:

  • Subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side anastomosis to the femoral artery or to an upper extremity artery
  • EVICEL Fibrin Sealant is used as an adjunct to obtain haemostasis at a target anastomosis/es
  • Subjects must be willing to and capable of participating in the study, and provide written informed consent

Exclusion Criteria:

  • Subjects with known intolerance to blood products
  • Subjects unwilling to receive blood products
  • Subjects with any intra-operative findings that may preclude the use of a fibrin sealant to control suture line anastomotic bleeding
  • Subject participating in another study with an investigational (pre-approved) drug or device within 30 days of surgery
  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: NCT01158261

Locations
United States, Florida
Baptist Health Medical Center
Jacksonville, Florida, United States, 32207
Memorial Hospital
Jacksonville, Florida, United States, 32216
Sponsors and Collaborators
Ethicon, Inc.
OMRIX Biopharmaceuticals
Investigators
Study Director: Richard Kocharian, MD Ethicon, Inc.
  More Information

No publications provided

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01158261     History of Changes
Other Study ID Numbers: 400-08-004
Study First Received: July 6, 2010
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ethicon, Inc.:
hemostasis

Additional relevant MeSH terms:
Hemorrhage
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Pathologic Processes
Fibrin Tissue Adhesive
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014