Phase 4
Completed N=252
The Bioseal Vascular Study
Cardiovascular Bleeding · Vascular Bleeding · hemorrhage
Source: ClinicalTrials.gov NCT02094885 ↗
Enrolled (actual)
252
Serious AEs
9.5%
Results posted
Sep 2016
Primary outcomePrimary: Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application. — 96; 88.2 percentage of patients
◆ Published Evidence
Emerging
5citations · ~3 / year
The role of sealants for achieving anastomotic hemostasis in vascular surgery.
Summary
To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.
Linked Publications
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The role of sealants for achieving anastomotic hemostasis in vascular surgery.
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 | — |
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) and the linked publication. 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.