Phase 2 N=42 Randomized Treatment

The Fibrin Pad Cardiovascular Study

Cardiovascular Disease

Bottom Line

View on ClinicalTrials.gov: NCT01681030 ↗

Enrolled (actual)

Serious AEs

45.2%

Results posted

Mar 2018

Primary outcome: Primary: Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. — 12; 6; 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: EVARREST™ (Biological); Topical hemostat (Biological); Standard of Care (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ethicon, Inc.
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.	12; 6; 5	—
SECONDARY Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application	12; 11; 7	—
SECONDARY Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application	12; 12; 8	—
SECONDARY Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment	0; 5; 0	—
SECONDARY Number of Participants With Adverse Events Potentially Related to Thrombotic Events	0; 2; 2	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01681030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.