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CompletedNCT01500135VASUSUpdated Feb 8, 2017Results posted

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 interventional study of TachoSil® and Surgicel® Original in Bleeding, sponsored by Takeda. Completed at 37 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-08.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 indication across several surgical procedures and organ systems in the USA.

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.

02

Conditions studied

  • Bleeding

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Keywords

  • Vascular Surgery
  • Secondary treatment of needle hole bleeding
  • Subjects undergoing vascular surgery and who need supportive treatment in order to control bleeding
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 150 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    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.

    Drug: TachoSil®

  • Active comparator
    Surgicel® Original

    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.

    Drug: Surgicel® Original

Interventions

  • DrugTachoSil®

    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.

  • DrugSurgicel® Original

    Surgicel® Original is an absorbable hemostat (oxidized regenerated cellulose)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 3 minutes

Secondary outcomes

  1. 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.

    Time frame: Within 5 minutes

  2. 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.

    Time frame: Within 10 minutes

07

Results

Posted Feb 8, 2017

Participant flow

Participants took part in the study at 23 investigative sites in the United States from 09 March 2012 to 16 December 2015.

Participant flow — Overall Study
MilestoneTachoSil®Surgicel® Original
Started10050
Completed8339
Not completed1711
Withdrew: Withdrawal of consent40
Withdrew: Lost to follow-up64
Withdrew: Fatal adverse event (ae)55
Withdrew: Principal investigator (pi) discretion10
Withdrew: Patient missed scheduled appointments01
Withdrew: Participant was a safety concern10
Withdrew: Patient unable to make follow-up visit01

Outcome measures

PrimaryPercentage 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.

Time frame:
Within 3 minutes
Reported as:
Number · percentage of participants
Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment
percentage of participantsTachoSil®Surgicel® Original
Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment26.0 (17.7 to 35.7)18.0 (8.6 to 31.4)
Statistical analysis
  • TachoSil® vs Surgicel® Original · Regression, Logistic · p = 0.276 (Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.) · Odds ratio (or): 1.62 · 95% CI 0.68 to 3.88
SecondaryPercentage 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.

Time frame:
Within 5 minutes
Reported as:
Number · percentage of participants
Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment
percentage of participantsTachoSil®Surgicel® Original
Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment39.0 (29.4 to 49.3)42.0 (28.2 to 56.8)
Statistical analysis
  • TachoSil® vs Surgicel® Original · Regression, Logistic · p = 0.684 (Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.) · Odds ratio (or): 0.85 · 95% CI 0.40 to 1.82
SecondaryTime 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.

Time frame:
Within 10 minutes
Reported as:
Median · minutes
Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment
minutesTachoSil®Surgicel® Original
Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment8.0 ± 18.878.0 ± 14.63
Statistical analysis
  • TachoSil® vs Surgicel® Original · Proportional Hazard Model · p = 0.684 (P-value was adjusted using Hochberg's adjustment for multiplicity.) · Hazard ratio (hr): 1.14 · 95% CI 0.7 to 1.8

Adverse events

Collected over From the signing of informed consent to the follow-up visit (Up to 6 Months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TachoSil®—49/99 (49.5%)52/99 (52.5%)
Surgicel® Original—19/50 (38%)28/50 (56%)
Most frequent serious events
Showing 10 of 99
Most frequent serious events
EventTachoSil®Surgicel® Original
PneumoniaInfections and infestations6/990/50
Acute myocardial infarctionCardiac disorders4/993/50
Acute kidney injuryRenal and urinary disorders2/993/50
Respiratory failureRespiratory, thoracic and mediastinal disorders0/993/50
Wound infectionInfections and infestations5/990/50
Wound dehiscenceInjury, poisoning and procedural complications5/991/50
SepsisInfections and infestations4/991/50
Vascular graft thrombosisInjury, poisoning and procedural complications4/992/50
Ventricular tachycardiaCardiac disorders0/992/50
GangreneInfections and infestations0/992/50
Most frequent other events
Showing 10 of 16
Most frequent other events
EventTachoSil®Surgicel® Original
AnaemiaBlood and lymphatic system disorders14/996/50
Wound dehiscenceInjury, poisoning and procedural complications3/996/50
Urinary retentionRenal and urinary disorders3/996/50
ConstipationGastrointestinal disorders11/995/50
HypotensionVascular disorders11/995/50
Oedema peripheralGeneral disorders10/990/50
HypomagnesaemiaMetabolism and nutrition disorders7/995/50
HypokalaemiaMetabolism and nutrition disorders6/995/50
Urinary tract infectionInfections and infestations9/994/50
Pain in extremityMusculoskeletal and connective tissue disorders9/993/50

Baseline characteristics

Full Analysis Set included all randomized participants.

Age, Continuous
Age, Continuous(years)TachoSil®Surgicel® OriginalTotal
Mean65.9 ± 10.2567.6 ± 12.8766.5 ± 11.18
Age, Customized
Age, Customized(participants)TachoSil®Surgicel® OriginalTotal
≤65 years482270
>65 years522880
Gender
Gender(Participants)TachoSil®Surgicel® OriginalTotal
Female332659
Male672491
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)TachoSil®Surgicel® OriginalTotal
White/Caucasian7934113
Asian011
Black or African American211031
Other044
Missing011
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)TachoSil®Surgicel® OriginalTotal
Hispanic or Latino4610
Non-Hispanic or Latino9542137
Unknown112
Missing011
Region of Enrollment
Region of Enrollment(participants)TachoSil®Surgicel® OriginalTotal
United States10050150
Height
Height(cm)TachoSil®Surgicel® OriginalTotal
Mean171.70 ± 10.197166.85 ± 10.381170.07 ± 10.479
Weight
Weight(kg)TachoSil®Surgicel® OriginalTotal
Mean81.15 ± 18.73876.20 ± 21.93579.49 ± 19.932

2 further baseline measures are reported on the registry.

08

Study locations

37 sites
  • Nycomed Investigational Site
    Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Little Rock, Arkansas, United States
  • Long Beach, California, United States
  • Nycomed Investigational Site
    Los Angeles, California, United States
  • Los Angeles, California, United States
  • Loveland, Colorado, United States
  • Jacksonville, Florida, United States
  • Nycomed Investigational Site
    Austell, Georgia, United States
  • Austell, Georgia, United States
  • Skokie, Illinois, United States
  • Nycomed Investigational Site
    Springfield, Illinois, United States
  • Springfield, Illinois, United States
  • Nycomed Investigational Site
    Lexington, Kentucky, United States
  • Lexington, Kentucky, United States
  • Worcester, Massachusetts, United States
  • Southfield, Michigan, United States
  • St. Louis, Missouri, United States
  • Hackensack, New Jersey, United States
  • Bronx, New York, United States
  • East Setauket, New York, United States
  • Flushing, New York, United States
  • Nycomed Investigational Site
    New York, New York, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Raleigh, North Carolina, United States
  • Winston Salem, North Carolina, United States
  • Toledo, Ohio, United States
  • Portland, Oregon, United States
  • Nycomed Investigational Site
    Galveston, Texas, United States
  • Galveston, Texas, United States
  • Nycomed Investigational Site
    Houston, Texas, United States
  • Houston, Texas, United States
  • Lubbock, Texas, United States
  • Nycomed Investigational Site
    Bellevue, Washington, United States
  • Bellevue, Washington, United States
  • Charleston, West Virginia, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01500135
Lead sponsor
Takeda
Collaborators
Baxter Healthcare Corporation
Responsible party
Sponsor
First posted
Dec 26, 2011
Start date
Mar 2012
Primary completion
Jun 2015
Completion
Dec 2015
Results posted
Feb 8, 2017
Last update
Feb 8, 2017

Study contacts

Medical Director Clinical Science
study director · Takeda

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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