The Bioseal Vascular Study

Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094885
• Other study ID #: BIOS-13-003
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2014
• Last updated: February 7, 2018
• Start date: February 1, 2014
• Est. completion date: December 1, 2014

Study information

• Verified date: February 2018
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: December 1, 2014
• Est. primary completion date: November 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Bleeding
• Hemorrhage
• Vascular Bleeding

Intervention

Biological:
• Bioseal Fibrin Sealant

Other:
• Manual Compression

Locations

Country	Name	City	State
China	Clinical Investigation Site #26	Beijing
China	Clinical Investigation Site #28	Beijing
China	Clinical Investigation Site #22	Chengdu	Sichuan
China	Clinical Investigation Site #21	Guangzhou City	Guangdong
China	Clinical Investigation Site #30	Jinan	Shandong
China	Clinical Investigation Site #31	Nanjing	Jiangsu
China	Clinical Investigation Site #32	Nanjing	Jiangsu
China	Clinical Investigation Site #23	Shanghai
China	Clinical Investigation Site #25	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ethicon, Inc.	Guangzhou Bioseal Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Intra-operative, 3 and 6 minutes following randomization
Secondary	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.	Intra-operative, 10 minutes following randomization
Secondary	Percentage of Participants With Potential Bleeding-related Adverse Events	Percentage of participants with potential bleeding-related adverse events by study group	30-days follow-up