The Bioseal Vascular Study
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
1 other identifier
interventional
252
1 country
9
Brief Summary
To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2014
Shorter than P25 for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 20, 2014
CompletedFirst Posted
Study publicly available on registry
March 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
September 12, 2016
CompletedMarch 8, 2018
February 1, 2018
9 months
March 20, 2014
July 26, 2016
February 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.
Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.
Intra-operative, 10 minutes following randomization
Secondary Outcomes (3)
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
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
Study Arms (2)
Bioseal Fibrin Sealant
EXPERIMENTALA porcine-derived fibrin sealant consisting of thrombin and fibrinogen
Manual compression
OTHERManual 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ethicon, Inc.lead
- Guangzhou Bioseal Biotechnology Co., Ltd.collaborator
Study Sites (9)
Clinical Investigation Site #21
Guangzhou, Guangdong, 510080, China
Clinical Investigation Site #32
Nanjing, Jiangsu, 210008, China
Clinical Investigation Site #31
Nanjing, Jiangsu, 210029, China
Clinical Investigation Site #30
Jinan, Shandong, 250021, China
Clinical Investigation Site #22
Chengdu, Sichuan, 610041, China
Clinical Investigation Site #26
Beijing, 100029, China
Clinical Investigation Site #28
Beijing, 100853, China
Clinical Investigation Site #25
Shanghai, 2000011, China
Clinical Investigation Site #23
Shanghai, 200032, China
Related Publications (1)
Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.
PMID: 38695613DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonathan Batiller, Senior Clinical Director
- Organization
- Ethicon, Inc
Study Officials
- STUDY DIRECTOR
Richard Kocharian, MD, PhD
Ethicon, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2014
First Posted
March 24, 2014
Study Start
February 1, 2014
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
March 8, 2018
Results First Posted
September 12, 2016
Record last verified: 2018-02