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Completed

NCT Number: NCT01681030

The Fibrin Pad Cardiovascular Study

This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Investigation Site #5, Indianapolis, Indiana, 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 of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass;
  • Subjects must be willing to participate in the study and provide written informed consent.

Exclusion criteria

  • Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
  • Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 30 day follow up period after surgery.
  • Female subjects who are pregnant or nursing.

Treatment and study plan

EVARREST™

Biological

EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).

Topical hemostat

Biological

Equine collagen with Human Fibrinogen and Human Thrombin

Standard of care

Other

SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.

Primary outcomes

  1. Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.

    Time frame: Intraoperative, 3 minutes following treatment application

    Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closur

Secondary outcomes

  1. Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application

    Time frame: Intraoperative, 6 minutes following treatment application

    The number of subjects achieving hemostatic success at 6 minutes following treatment application.

  2. Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application

    Time frame: Intraoperative, 10 minutes following treatment application

    Number of subjects achieving hemostatic success at 10 minutes following treatment application.

  3. Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment

    Time frame: Intra-operative, prior initiation of final chest wall closure. Safety Issue:

    The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had re-bleeding requiring treatment

  4. Number of Participants With Adverse Events Potentially Related to Thrombotic Events

    Time frame: 30 days (+ 14 days) following surgery

    The number of subjects with an adverse event potentially related to a thrombotic event

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Registry information

Official study title

A Randomized, Controlled, Comparative Phase II Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 7, 2012
Registry last updated
Jun 12, 2018

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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