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

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

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Cardiovascular Bleeding; Vascular Bleeding
• Intervention / Treatment: Biological: Bioseal Fibrin Sealant; Other: Manual Compression

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • Clinical Investigation Site #26
  • Beijing, China, 100853
    • Clinical Investigation Site #28
  • Shanghai, China, 2000011
    • Clinical Investigation Site #25
  • Shanghai, China, 200032
    • Clinical Investigation Site #23
  • Guangdong
    • Guangzhou City, Guangdong, China, 510080
      • Clinical Investigation Site #21
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Clinical Investigation Site #32
    • Nanjing, Jiangsu, China, 210029
      • Clinical Investigation Site #31
  • Shandong
    • Jinan, Shandong, China, 250021
      • Clinical Investigation Site #30
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Clinical Investigation Site #22

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bioseal Fibrin Sealant; A porcine-derived fibrin sealant consisting of thrombin and fibrinogen	Biological: Bioseal Fibrin Sealant
Other: Manual compression; 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.	Other: Manual Compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Ethicon, Inc.
• Collaborators: Guangzhou Bioseal Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 24, 2014

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: February 7, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: BIOS-13-003