Phase 2
Completed N=42
The Fibrin Pad Cardiovascular Study
Source: ClinicalTrials.gov NCT01681030 ↗Enrolled (actual)
42
Serious AEs
45.2%
Results posted
Mar 2018
Primary outcomePrimary: Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. — 12; 6; 5 Participants
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.
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 | — |
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.
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. Informational only — not medical advice.