A study evaluating the effect of EVARREST™ Fibrin Sealant Patch ascompared to Tachosil in controlling bleeding during cardivascular surgery

Phase 1

• Conditions: subjects undergoing major aortic surgery, including ascending,arch, or descending aorta replacement, requiring adjunctive support forhemostasis at the anastomotic suture line; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2013-003464-31-GB
• Lead Sponsor: Ethicon Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-26
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Pre-Operative
1. Subjects =18 years of age, requiring an elective or urgent, open aortic
surgical procedure utilizing cardiopulmonary bypass;
2. Subjects must be willing to participate in the study and provide written
informed consent.

Intra-Operative
1. Presence of an appropriate Target Bleeding Site along the anastomotic
suture line, involving a synthetic aortic graft, as identified intraoperatively
by the investigator;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

Pre-Operative
1. Subjects with known intolerance to blood products or to one of the
components of the study product or unwilling to receive blood
products;
2. Exposure to another investigational drug or device in a clinical trial
within 30 days prior to surgery or anticipated in the 60 day follow up
period after surgery.
3. Female subjects who are pregnant or nursing.

Intra-Operative
1. TBS is from a large defects in visible arteries or veins where the injured
vascular wall requires repair and maintenance of vessel patency or
where there would be persistent exposure of EVARREST™ Fibrin Sealant
Patch to blood flow and/or pressure during absorption of the product;
2. TBS with major arterial bleeding requiring suture or mechanical ligation;
3. TBS involves an expanded polytetrafluoroethylene (ePTFE) graft
4. TBS within an actively infected field;
5. Bleeding site is in, around, or in proximity to foramina in bone, or areas
of bony confine;
6. Subjects with any intra-operative findings identified by the investigator
that may preclude conduct of the study procedure;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified