BleedingPhase 3VASUSNCT01500135

Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery

A Phase 3 study testing TachoSil® and Surgicel® Original in people with Bleeding, run by Takeda at 37 sites in United States.

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

Present trial is the third study that in combination with two completed studies (one being a trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted toward providing clinical safety and efficacy data to support extending the current label of TachoSil® to a general hemostasis… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bleeding
What is being tested?: TachoSil® and Surgicel® Original
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 37 sitesUnited States
Study dates: Mar 2012to Dec 2015
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Main Inclusion Criteria:

Planned elective and subacute procedures with a polytetrafluoroethylene (PTFE) graft including at least one expected end-to-side anastomosis of a PTFE graft to the femoral artery (e.g. femoral-femoral cross-over, aorto-(bi)femoral, axillo-(bi)femoral, femoro-popliteal, femoro-crural bypass grafting), a PTFE patch angioplasty of the femoral artery, or an end-to-side anastomosis of a PTFE graft to an upper extremity artery in connection with arteriovenous bypass grafting for dialysis access.
The evaluation site for the planned femoral anastomosis must be a de novo site.
The participant must be heparinized during surgery.

Intra-operatively (before randomization)

The participant has a need for secondary hemostatic treatment
Verification of the evaluation site being a de novo site
Verification of the surgical procedure performed as being either an end-to-side or PTFE patch angioplasty.

Main Exclusion Criteria:

Thrombolytic therapy administered within 12 hours before surgery (e.g. the recombinant tissue plasminogen activator (rt-PA) Alteplase).
Liver cirrhosis.

Intra-operatively (before randomization)

Severe bleeding at the anastomosis of the arterial bypass using PTFE graft prosthesis or the PTFE patch angioplasty
No bleeding (dry surgical field) at the targeted application area
Disseminated intravascular coagulopathy (DIC)
Application of topical hemostatic material including fibrin sealant/glue on the evaluation site.

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

United States37 sites

Nycomed Investigational Site
Austell, Georgia
Study site
Austell, Georgia
Nycomed Investigational Site
Bellevue, Washington
Study site
Bellevue, Washington
Nycomed Investigational Site
Birmingham, Alabama
Study site
Birmingham, Alabama
Study site
Charleston, West Virginia
Study site
Durham, North Carolina
Study site
East Setauket, New York
Study site
Flushing, New York
Nycomed Investigational Site
Galveston, Texas
Study site
Galveston, Texas
Study site
Hackensack, New Jersey
Nycomed Investigational Site
Houston, Texas
Study site
Houston, Texas
Study site
Jacksonville, Florida
Nycomed Investigational Site
Lexington, Kentucky
Study site
Lexington, Kentucky
Study site
Little Rock, Arkansas
Study site
Long Beach, California
Nycomed Investigational Site
Los Angeles, California
Study site
Los Angeles, California
Study site
Loveland, Colorado
Study site
Lubbock, Texas
Nycomed Investigational Site
New York, New York
Study site
New York, New York
Study site
Portland, Oregon
Study site
Raleigh, North Carolina
Study site
Skokie, Illinois
Study site
Southfield, Michigan
Nycomed Investigational Site
Springfield, Illinois
Study site
Springfield, Illinois
Study site
St Louis, Missouri
Study site
The Bronx, New York
Study site
Toledo, Ohio
Study site
Winston-Salem, North Carolina
Study site
Worcester, Massachusetts

Other trials in United States

About this study

Official title: A Randomized, Open Label, Parallel-group, Multi-center Trial to Compare Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery

Read the detailed description

The drug being tested in this study is called TachoSil®. TachoSil® was used to treat people undergoing scheduled subacute vascular surgery. This study looked at how well TachoSil® patches stopped bleeding at the surgical site compared to Surgicel® Original patches.

The study enrolled 150 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two open label treatment groups in a 2:1 ratio:

TachoSil®
Surgicel® Original

This multi-center trial was conducted in the United States. The overall time to participate in this study was approximately 6 months. Participants made multiple visits to the clinic, including safety follow-up visits at 1, 3 and 6 months after surgery.

Conditions: Bleeding
Being tested: TachoSil®, Surgicel® Original
Keywords: Vascular Surgery, Secondary treatment of needle hole bleeding, Subjects undergoing vascular surgery and who need supportive treatment in order to control bleeding
Medical subject headings: Hemorrhage

What participants receive

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

TachoSil®Drug
TachoSil® is a sterile, ready-to-use, absorbable patch for intra-operative topical application. It consists of an equine collagen patch coated with fibrin glue components: human fibrinogen and human thrombin.
Surgicel® OriginalDrug
Surgicel® Original is an absorbable hemostat (oxidized regenerated cellulose)

Study groups in NCT01500135
Study group	Role	What they receive
TachoSil®	Experimental	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated. Receives: Drug: TachoSil®
Surgicel® Original	Active comparator	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated. Receives: Drug: Surgicel® Original

What is being measured

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

Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment
After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. The first assessment of hemostasis was at minute 3: the pressure was carefully relieved, and the area was observed for visual bleeding at the site of the IMP. If no bleeding was visible, hemostasis was obtained and recorded.
Measured: Within 3 minutes

Secondary outcomes (2)

Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment
After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. If hemostasis was not obtained at minute 3, pressure was immediately reapplied. Hemostasis was re-assessed at minutes 4 and 5.
Measured: Within 5 minutes
Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment
After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. Hemostasis was assessed at 3, 4, and 5 minutes. If hemostasis was not obtained after 5 minutes a second application of IMP was applied with 3 minutes of light pressure and hemostasis was re-assessed at 8, 9 and 10 minutes.
Measured: Within 10 minutes

Timeline

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

Mar 2012Dec 2015

First posted26 Dec 2011 (estimated)
Study startMar 2012
Primary completionJun 2015
Study completionDec 2015

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.
Other trials for BleedingStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01500135
Sponsor's protocol ID: TC-2402-039-SP
Other IDs: U1111-1163-1653
Acronym: VASUS
Status last verified: Dec 2016
First submitted: 21 Dec 2011
Last updated: 8 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label, Parallel-group, Multi-center Trial to Compare Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery
ClinicalTrials.gov ID: NCT01500135
Acronym / sponsor ID: VASUS / TC-2402-039-SP
Conditions: Bleeding
Keywords: Vascular Surgery, Secondary treatment of needle hole bleeding, Subjects undergoing vascular surgery and who need supportive treatment in order to control bleeding
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Collaborators: Baxter Healthcare Corporation
Study start: Mar 2012
Primary completion: Jun 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 26 Dec 2011 (estimated)
Results: Posted 8 Feb 2017

Clinical summary

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

Detailed description

The study enrolled 150 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two open label treatment groups in a 2:1 ratio:

TachoSil®
Surgicel® Original

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TachoSil®	Experimental	Drug: TachoSil®TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
Surgicel® Original	Active comparator	Drug: Surgicel® OriginalSurgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.

Who may qualify

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

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
TachoSil®TachoSil® is a sterile, ready-to-use, absorbable patch for intra-operative topical application. It consists of an equine collagen patch coated with fibrin glue components: human fibrinogen and human thrombin.	Drug	TachoSil®
Surgicel® OriginalSurgicel® Original is an absorbable hemostat (oxidized regenerated cellulose)	Drug	Surgicel® Original

Primary outcome

Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment
Time frame: Within 3 minutes
After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. The first assessment of hemostasis was at minute 3: the pressure was carefully relieved, and the area was observed for visual bleeding at the site of the IMP. If no bleeding was visible, hemostasis was obtained and recorded.

2 secondary outcomes

Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment
Time frame: Within 5 minutes
Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment
Time frame: Within 10 minutes

Results and safety

Results posted to the registry on 8 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TachoSil®	100	83
Surgicel® Original	50	39

Primary outcome: Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment

Time frame: Within 3 minutes. Number (95% Confidence Interval). Unit: percentage of participants

Measure	TachoSil® n = 100	Surgicel® Original n = 50
Value	26.0 (17.7 to 35.7)	18.0 (8.6 to 31.4)

TachoSil® vs Surgicel® Original: Odds Ratio (OR): 1.62 (95% CI 0.68 to 3.88), p = 0.276, Regression, Logistic

Population analysed: Full Analysis Set (FAS) included all randomized participants. The endpoint for one participant on TachoSil® was missing; it was assumed that hemostasis was not reached within 3 minutes.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the signing of informed consent to the follow-up visit (Up to 6 Months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TachoSil®	49 of 99 (49.5%)	52 of 99 (52.5%)	Not reported
Surgicel® Original	19 of 50 (38%)	28 of 50 (56%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Medical Director Clinical Science study director

Takeda

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TachoSil® and Surgicel® Original in people with Bleeding, run by Takeda at 37 sites in United States.

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

Who may be eligible to take part?

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 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 8 Feb 2017). 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?

Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment (time frame: Within 3 minutes). 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 NCT01500135.

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 Feb 2017.