Cardiovascular BleedingPhase 4NCT02094885

The Bioseal Vascular Study

A Phase 4 study testing Bioseal Fibrin Sealant and Manual Compression in people with Cardiovascular Bleeding and Vascular Bleeding, run by Ethicon, Inc. at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Cardiovascular Bleeding, Vascular Bleeding, Hemorrhage
What is being tested?: Bioseal Fibrin Sealant and Manual Compression
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 252 participants
Where: 9 sitesChina
Study dates: 1 Feb 2014to 1 Dec 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

China9 sites

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

Other trials in China

About this 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

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

Conditions: Cardiovascular Bleeding, Vascular Bleeding, Hemorrhage
Being tested: Bioseal Fibrin Sealant, Manual Compression
Medical subject headings: Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bioseal Fibrin SealantBiological
Manual CompressionOther

Study groups in NCT02094885
Study group	Role	What they receive
Bioseal Fibrin Sealant	Experimental	A porcine-derived fibrin sealant consisting of thrombin and fibrinogen Receives: Biological: Bioseal Fibrin Sealant
Manual compression	Other	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. Receives: Other: Manual Compression

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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.
Measured: 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
Measured: 30-days follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20141 Dec 2014

First posted24 Mar 2014 (estimated)
Study start1 Feb 2014
Primary completion1 Nov 2014
Study completion1 Dec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cardiovascular BleedingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02094885
Sponsor's protocol ID: BIOS-13-003
Status last verified: Feb 2018
First submitted: 20 Mar 2014
Last updated: 8 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 38695613

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiovascular Bleeding trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02094885
Acronym / sponsor ID: BIOS-13-003
Conditions: Cardiovascular Bleeding, Vascular Bleeding, Hemorrhage
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: Ethicon, Inc.Industry (pharma, biotech, devices)
Collaborators: Guangzhou Bioseal Biotechnology Co., Ltd.
Study start: 1 Feb 2014 (actual)
Primary completion: 1 Nov 2014 (actual)
Study completion: 1 Dec 2014 (actual)
First posted: 24 Mar 2014 (estimated)
Results: Posted 12 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Bioseal Fibrin Sealant	Experimental	Biological: Bioseal Fibrin SealantA porcine-derived fibrin sealant consisting of thrombin and fibrinogen
Manual compression	Other	Other: Manual CompressionManual 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bioseal Fibrin Sealant	Biological	Bioseal Fibrin Sealant
Manual Compression	Other	Manual compression

Primary outcome

Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.
Time frame: Intra-operative, 10 minutes following randomization
Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.

3 secondary outcomes

Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application
Time frame: Intra-operative, 3 and 6 minutes following randomization
Number of Participants Requiring Alternative Treatment Due to Treatment Failure*
Time frame: Intra-operative, 10 minutes following randomization
Percentage of Participants With Potential Bleeding-related Adverse Events
Time frame: 30-days follow-up

Results and safety

Results posted to the registry on 12 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bioseal Fibrin Sealant	125	123
Manual Compression	127	122

Primary outcome: Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.

Time frame: Intra-operative, 10 minutes following randomization. Number (95% Confidence Interval). Unit: percentage of patients

Measure	Bioseal Fibrin Sealant n = 125	Manual Compression n = 127
Value	96 (90.9 to 98.7)	88.2 (81.3 to 93.2)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bioseal Fibrin Sealant	13 of 125 (10.4%)	15 of 125 (12%)	Not reported
Manual Compression	11 of 127 (8.7%)	13 of 127 (10.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38695613Ma 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.

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Active, not recruiting
Auricular VNS Following Subarachnoid Hemorrhage
Subarachnoid Hemorrhage
RecruitingObservational study
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH)
Subdural Hematoma, Subdural Hematoma, Chronic
RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Kocharian, MD, PhD study director

Ethicon, Inc.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bioseal Fibrin Sealant and Manual Compression in people with Cardiovascular Bleeding and Vascular Bleeding, run by Ethicon, Inc. at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application. (time frame: Intra-operative, 10 minutes following randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02094885, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.