The Bioseal Vascular Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-01

Study Completion Date

2014-12-01

Brief Summary

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

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Detailed Description

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Conditions

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Cardiovascular Bleeding Vascular Bleeding Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bioseal Fibrin Sealant

A porcine-derived fibrin sealant consisting of thrombin and fibrinogen

Group Type EXPERIMENTAL

Bioseal Fibrin Sealant

Intervention Type BIOLOGICAL

Manual compression

Manual compresssion (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.

Group Type OTHER

Manual Compression

Intervention Type OTHER

Interventions

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Bioseal Fibrin Sealant

Intervention Type BIOLOGICAL

Manual Compression

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Subjects between 18 and 75 years of age;
2. 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 ;
3. Able and willing to comply with procedures required by protocol;
4. Signed and dated written informed consent prior to any study related procedures.

Exclusion Criteria

1. Subjects with any intra-operative findings that may preclude conducting of the study procedures;
2. Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than Bioseal on the TBS;
3. Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
4. Subjects with known allergies to or previously used porcine derived products;
5. Female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period.
6. The subject, in the opinion of the investigator, would not be suitable for participation in the study.
7. Subjects who participated in another trial within 30 days prior to the planned start of treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No