subjects undergoing major aortic surgery, including ascending, arch, or descending aorta replacement, requiring adjunctive support for hemostasis at the anastomotic suture line
Conditions
Interventions
Trade Name: EVARREST™
Product Name: EVARREST Fibrin Sealant Patch
Pharmaceutical Form: Medicated sponge
INN or Proposed INN: Human Thrombin
CAS Number: 9002-04-4
Other descriptive name: HUMAN THROMBI
Sponsors
Ethicon Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. 6 minutes following treatment application 2. 10 minutes following treatment application 3. From 3 minutes to initiation of final chest wall closure. 4. from randomization through 60 day follow up visit;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. 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. 3. Incidence of re-bleeding requiring treatment after initial establishment of TBS hemostasis at 3 minutes. 4. Incidence of adverse events. | — |
Countries
Australia, Belgium, Japan, Russian Federation, United Kingdom, United States
Contacts
Public ContactClinical Development
Johnson & Johnson Medical Ltd.
Outcome results
None listed