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The Bioseal Vascular Study

Primary Purpose

Cardiovascular Bleeding, Vascular Bleeding, Hemorrhage

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bioseal Fibrin Sealant
Manual Compression
Sponsored by
Ethicon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Bleeding

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Clinical Investigation Site #21
  • Clinical Investigation Site #32
  • Clinical Investigation Site #31
  • Clinical Investigation Site #30
  • Clinical Investigation Site #22
  • Clinical Investigation Site #26
  • Clinical Investigation Site #28
  • Clinical Investigation Site #25
  • Clinical Investigation Site #23

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Bioseal Fibrin Sealant

Manual compression

Arm Description

A porcine-derived fibrin sealant consisting of thrombin and fibrinogen

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application
Percentage of participants with Hemostasis at the TBS at 3 and 6 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.
Number of Participants Requiring Alternative Treatment Due to Treatment Failure*
Alternative treatments include the use of additional hemostatic methods, including collagen, manual compression, oxidized regenerated cellulose and suture. Manual compression (MC) may be applied after the initial 10 minute observation period as an alternative treatment due to treatment failure in either group. For participants with a treatment failure in MC group, the addition treatment of MC is applied after the initial 10 minute observation period.
Percentage of Participants With Potential Bleeding-related Adverse Events
Percentage of participants with potential bleeding-related adverse events by study group

Full Information

First Posted
March 20, 2014
Last Updated
February 7, 2018
Sponsor
Ethicon, Inc.
Collaborators
Guangzhou Bioseal Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02094885
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2014 (Actual)
Primary Completion Date
November 1, 2014 (Actual)
Study Completion Date
December 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.
Collaborators
Guangzhou Bioseal Biotechnology Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Bleeding, Vascular Bleeding, Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bioseal Fibrin Sealant
Arm Type
Experimental
Arm Description
A porcine-derived fibrin sealant consisting of thrombin and fibrinogen
Arm Title
Manual compression
Arm Type
Other
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Bioseal Fibrin Sealant
Intervention Type
Other
Intervention Name(s)
Manual Compression
Primary Outcome Measure Information:
Title
Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.
Description
Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.
Time Frame
Intra-operative, 10 minutes following randomization
Secondary Outcome Measure Information:
Title
Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application
Description
Percentage of participants with Hemostasis at the TBS at 3 and 6 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.
Time Frame
Intra-operative, 3 and 6 minutes following randomization
Title
Number of Participants Requiring Alternative Treatment Due to Treatment Failure*
Description
Alternative treatments include the use of additional hemostatic methods, including collagen, manual compression, oxidized regenerated cellulose and suture. Manual compression (MC) may be applied after the initial 10 minute observation period as an alternative treatment due to treatment failure in either group. For participants with a treatment failure in MC group, the addition treatment of MC is applied after the initial 10 minute observation period.
Time Frame
Intra-operative, 10 minutes following randomization
Title
Percentage of Participants With Potential Bleeding-related Adverse Events
Description
Percentage of participants with potential bleeding-related adverse events by study group
Time Frame
30-days follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Kocharian, MD, PhD
Organizational Affiliation
Ethicon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Investigation Site #21
City
Guangzhou City
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Clinical Investigation Site #32
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Clinical Investigation Site #31
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Clinical Investigation Site #30
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Facility Name
Clinical Investigation Site #22
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Clinical Investigation Site #26
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Clinical Investigation Site #28
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Clinical Investigation Site #25
City
Shanghai
ZIP/Postal Code
2000011
Country
China
Facility Name
Clinical Investigation Site #23
City
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

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The Bioseal Vascular Study

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