HemorrhagePhase 3NCT01192022
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
A Phase 3 study testing TachoSil® and Surgicel® Original in people with Hemorrhage, run by Takeda at 17 sites in United States.
Trial summary
The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original. Hemostatic efficacy will be evaluated intraoperatively after application of randomized treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemorrhage
- What is being tested?
- TachoSil® and Surgicel® Original
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 17 sitesUnited States
- Study dates
- Aug 2010to May 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Resection of at least the equivalent tissue volume of 1 anatomical segment of the liver
- Minor to moderate (oozing/diffuse) bleeding from the resection area persisting after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation
- Need for additional supportive hemostatic treatment
- Expected ability to lightly press the trial treatment to the liver resection wound for 3 minutes
Who cannot join
- Indication for emergency surgery
- Known coagulopathy (as judged relevant by the investigator)
- Known or suspected hypersensitivity to any ingredient of the investigational medicinal products (e.g. human fibrinogen, human thrombin and/or collagen of any origin)
- Patient unwilling to receive blood products
- Known current alcohol or drug abuse
- Pregnancy, breastfeeding, no use of acceptable contraceptive method in females of childbearing potential
Show all 11Show fewer
- Dry surgical field of the targeted application area
- Occurrence of any serious surgical complication
- Disseminated intravascular coagulopathy (DIC), i.e. microvascular bleeding
- Application of topical hemostatic material on the liver resection wound
- Radiofrequency precoagulation of the liver resection wound except focal radiofrequency ablation of vessels as primary hemostatic treatment
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Study site
Burlington, Massachusetts
Study site
Charleston, South Carolina
Study site
Charlotte, North Carolina
Study site
Charlottesville, Virginia
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Madison, Wisconsin
Study site
Memphis, Tennessee
Study site
Nashville, Tennessee
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Newark, New Jersey
Study site
Philadelphia, Pennsylvania
Study site
St Louis, Missouri
Study site
Washington D.C., District of Columbia
About this study
Official title: A Randomized, Open Label, Parallel-group, Multi-center Trial to Compare the Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original. Hemostatic efficacy will be evaluated intraoperatively after application of randomized treatment.
- Conditions
- Hemorrhage
- Being tested
- TachoSil®, Surgicel® Original
- Keywords
- Liver resection, Liver transplantation, Liver surgery, Secondary hemostasis
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TachoSil®Biological
Intraoperative application as secondary hemostatic treatment
Surgicel® OriginalDevice
Intraoperative application as secondary hemostatic treatment
| Study group | Role | What they receive |
|---|---|---|
| TachoSil® | Active comparator | TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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: Biological: TachoSil® |
| Surgicel® Original | Active comparator | Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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: Device: Surgicel® Original |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes
3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.
Measured: within 3 minutes
Secondary outcomes (2)
Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes
3, 4 and 5 minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.
Measured: within 5 minutes
Time to Intraoperative Hemostasis at Target Bleeding Site
The target bleeding area was observed at 3, 4, 5, 8, 9, and 10 minutes after the patch was applied to see if the bleeding stopped, and time in minutes until bleeding stopped was recorded.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2013
- Study completionMay 2013
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 HemorrhageStudies 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
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192022
- Sponsor's protocol ID
- TC-2402-040-SP
- Other IDs
- U1111-1130-9121
- Status last verified
- Oct 2015
- First submitted
- 27 Aug 2010
- Last updated
- 25 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Genyk Y, Kato T, Pomposelli JJ, Wright JK Jr, Sher LS, Tetens V, Chapman WC. Fibrin Sealant Patch (TachoSil) vs Oxidized Regenerated Cellulose Patch (Surgicel Original) for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection: A Randomized Controlled Trial. J Am Coll Surg. 2016 Mar;222(3):261-8. doi: 10.1016/j.jamcollsurg.2015.12.007. Epub 2015 Dec 18.
PubMed 26776356
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. 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 the Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
- ClinicalTrials.gov ID
- NCT01192022
- Acronym / sponsor ID
- TC-2402-040-SP
- Conditions
- Hemorrhage
- Keywords
- Liver resection, Liver transplantation, Liver surgery, Secondary hemostasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Posted 25 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original. Hemostatic efficacy will be evaluated intraoperatively after application of randomized treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TachoSil® | Active comparator | Biological: TachoSil®TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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 | Device: Surgicel® OriginalSurgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Resection of at least the equivalent tissue volume of 1 anatomical segment of the liver
- Minor to moderate (oozing/diffuse) bleeding from the resection area persisting after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation
- Need for additional supportive hemostatic treatment
- Expected ability to lightly press the trial treatment to the liver resection wound for 3 minutes
Key exclusion criteria (11 listed)
- Indication for emergency surgery
- Known coagulopathy (as judged relevant by the investigator)
- Known or suspected hypersensitivity to any ingredient of the investigational medicinal products (e.g. human fibrinogen, human thrombin and/or collagen of any origin)
- Patient unwilling to receive blood products
- Known current alcohol or drug abuse
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®Intraoperative application as secondary hemostatic treatment | Biological | TachoSil® |
| Surgicel® OriginalIntraoperative application as secondary hemostatic treatment | Device | Surgicel® Original |
Primary outcome
Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes
Time frame: within 3 minutes
3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.
2 secondary outcomes
Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes
Time frame: within 5 minutes
Time to Intraoperative Hemostasis at Target Bleeding Site
Time frame: 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26776356Genyk Y, Kato T, Pomposelli JJ, Wright JK Jr, Sher LS, Tetens V, Chapman WC. Fibrin Sealant Patch (TachoSil) vs Oxidized Regenerated Cellulose Patch (Surgicel Original) for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection: A Randomized Controlled Trial. J Am Coll Surg. 2016 Mar;222(3):261-8. doi: 10.1016/j.jamcollsurg.2015.12.007. Epub 2015 Dec 18.
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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 study director
Takeda
17 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 Hemorrhage, run by Takeda at 17 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?
The sponsor lists 4 inclusion and 11 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 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 25 Nov 2015). 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 Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes (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 NCT01192022, 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 25 Nov 2015.