A Prospective, Randomized, Controlled Phase IV Study to Compare Bioseal Versus Manual Compression as an Adjunct to Hemostasis in the Patients Undergoing Elective Vascular Surgery

Ethicon, Inc.9 sites in 1 country252 target enrollmentFebruary 1, 2014

ConditionsCardiovascular Bleeding Vascular Bleeding Hemorrhage

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Cardiovascular Bleeding
Sponsor: Ethicon, Inc.
Enrollment: 252
Locations: 9
Primary Endpoint: Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.

Registry

clinicaltrials.gov

Start Date

February 1, 2014

End Date

December 1, 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ethicon, Inc.

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.

Time Frame: Intra-operative, 10 minutes following randomization

Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.

Secondary Outcomes

Number of Participants Requiring Alternative Treatment Due to Treatment Failure*(Intra-operative, 10 minutes following randomization)
Percentage of Participants With Potential Bleeding-related Adverse Events(30-days follow-up)
Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application(Intra-operative, 3 and 6 minutes following randomization)