Phase 4
N=252
The Bioseal Vascular Study
Cardiovascular Bleeding · Vascular Bleeding · Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT02094885 ↗Enrolled (actual)
252
Serious AEs
9.5%
Results posted
Sep 2016
Primary outcome: Primary: Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application. — 96; 88.2 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bioseal Fibrin Sealant (Biological); Manual Compression (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ethicon, Inc.
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application. |
96; 88.2 | — |
| SECONDARY Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application |
84; 43.3; 96.0; 74.0 | — |
| SECONDARY Number of Participants Requiring Alternative Treatment Due to Treatment Failure* |
5; 15; 0; 2; 1; 1 | — |
| SECONDARY Percentage of Participants With Potential Bleeding-related Adverse Events |
2.4; 2.4 | — |
Summary
To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.
Eligibility Criteria
Inclusion Criteria
- Subjects between 18 and 75 years of age;
- Undergoing elective vascular surgical procedures and with the presence of an appropriate Target Bleeding Site (TBS) requiring an adjunct to achieve hemostasis as identified intra-operatively by the surgeon ;
- Able and willing to comply with procedures required by protocol;
- Signed and dated written informed consent prior to any study related procedures.
Exclusion Criteria
- Subjects with any intra-operative findings that may preclude conducting of the study procedures;
- Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than Bioseal on the TBS;
- Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
- Subjects with known allergies to or previously used porcine derived products;
- Female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period.
- The subject, in the opinion of the investigator, would not be suitable for participation in the study.
- Subjects who participated in another trial within 30 days prior to the planned start of treatment.
Data sourced from ClinicalTrials.gov (NCT02094885). 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.