Clinical trial NCT02094885: The Bioseal Vascular Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Bleeding
Vascular Bleeding
Hemorrhage
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Guangzhou Bioseal Biotechnology Co., Ltd.
First posted: 2014-03-24
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.
timeFrame: Intra-operative, 10 minutes following randomization
Secondary outcomes:
measure: Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application
timeFrame: Intra-operative, 3 and 6 minutes following randomization
measure: Number of Participants Requiring Alternative Treatment Due to Treatment Failure*
timeFrame: Intra-operative, 10 minutes following randomization
measure: Percentage of Participants With Potential Bleeding-related Adverse Events
timeFrame: 30-days follow-up
Other outcomes:
Locations:
city: Guangzhou City
country: China
facility: Clinical Investigation Site #21
state: Guangdong
city: Nanjing
country: China
facility: Clinical Investigation Site #32
state: Jiangsu
city: Nanjing
country: China
facility: Clinical Investigation Site #31
state: Jiangsu
city: Jinan
country: China
facility: Clinical Investigation Site #30
state: Shandong
city: Chengdu
country: China
facility: Clinical Investigation Site #22
state: Sichuan
city: Beijing
country: China
facility: Clinical Investigation Site #26
city: Beijing
country: China
facility: Clinical Investigation Site #28
city: Shanghai
country: China
facility: Clinical Investigation Site #25
city: Shanghai
country: China
facility: Clinical Investigation Site #23
Study officials:
affiliation: Ethicon, Inc.
name: Richard Kocharian, MD, PhD
role: STUDY_DIRECTOR
References: