The Bioseal Vascular Study

Ethicon

Status and phase: Completed; Phase 4

Conditions: Hemorrhage; Vascular Bleeding; Cardiovascular Bleeding

Treatments: Other: Manual Compression; Biological: Bioseal Fibrin Sealant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02094885

BIOS-13-003

Details and patient eligibility

About

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

Enrollment: 252 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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252 participants in 2 patient groups

Bioseal Fibrin Sealant

Experimental group

Description:

A porcine-derived fibrin sealant consisting of thrombin and fibrinogen

Treatment:

Biological: Bioseal Fibrin Sealant

Manual compression

Other group

Description:

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.

Treatment:

Other: Manual Compression