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Completed

NCT Number: NCT01158261

The Evicel Post-Authorization Surveillance Study

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.

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Key information

Conditions

Peripheral Vascular Disease Cardiovascular Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baptist Health Medical Center, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVICEL ™ Fibrin Sealant (Human)

Biological

Commercial Evicel

Other names: Fibrin Sealant (Human)

Primary outcomes

  1. Specific Safety Parameters

    Time frame: Up to 4-weeks post-operatively

    • Incidence of graft occlusion
    • Incidence of adverse events potentially related to non-graft thrombotic events
    • Incidence of bleeding events

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Collaborators

  • OMRIX Biopharmaceuticals

Registry information

Official study title

A Prospective, Single-Arm, Observational, Non-interventional Study for EVICEL ™ Fibrin Sealant (Human) When Used as an Adjunct to Haemostasis in Vascular Surgery

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 8, 2010
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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