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

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-BE

Lead Sponsor: Ethicon Inc

Brief Summary: Not available

Detailed Description: Not available

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;
a. Subjects in Japan between =18 and <20 years of age will require consent by the subject’s legal representative
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 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.;Secondary Objective: not applicable;Primary end point(s): Hemostasis at the TBS at 3-minutes following treatment application and with no re-bleeding requiring treatment at the TBS any time prior to initiation of final chest wall closure. Hemostasis is defined as no detectable bleeding at the TBS.;Timepoint(s) of evaluation of this end point: 3-minutes following treatment application

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Hemostasis at the TBS at 6 minutes following treatment application and with no re-bleeding requiring treatment at the TBS any time prior to initiation of final chest wall closure.<br><br>2. Hemostasis at the TBS at 10 minutes following treatment application and with no re-bleeding requiring treatment at the TBS any time prior to initiation of final chest wall closure.<br><br>3. Incidence of re-bleeding requiring treatment after initial establishment of TBS hemostasis at 3 minutes.<br><br>4. Incidence of adverse events.;Timepoint(s) of evaluation of this end point: 1. 6 minutes following treatment application<br>2. 10 minutes following treatment application<br>3. From 3 minutes to initiation of final chest wall closure.<br>4. from randomization through 60 day follow up visit

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