Surgical Resection of Superficial Renal TumourPhase 3NCT00241163
TachoComb S Versus Standard Surgical Treatment in Surgical Resection of Renal Tumour (TC-015-IN)
A Phase 3 study testing Fibrinogen (human) + thrombin (human) (TachoSil) in people with Surgical Resection of Superficial Renal Tumour, run by Takeda at 1 site in Denmark.
Trial summary
The overall objective is to compare efficacy and safety of TachoComb S and standard surgical treatment for the control of local bleeding in patients undergoing surgical resection of renal tumours. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Surgical Resection of Superficial Renal Tumour
- What is being tested?
- Fibrinogen (human) + thrombin (human) (TachoSil)
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- 1 siteDenmark
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of or above 18 years of age scheduled for resection of superficial tumour on the kidney and scheduled for open surgery. After the tumour resection the wound should be suitable for the treatments in the study, and the integrity of the urinary tract should be maintained.
Who cannot join
- Patients undergoing an emergency operation, or with more than one tumour will be excluded. Patients with a clinically abnormal value of prothrombin time or activated partial thromboplastin time, anamnetic evidence of coagulation disorders and a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen will be excluded. In case the tumour was resected by use of a laser scalpel, infrared coagulator or argon beamer and if any fibrin glue haemostatic was used before randomisation the patient will be excluded from the trial. Furthermore, patients will be excluded if extensive resection/extirpation of the kidney become necessary or in case of serious surgical complication occurring during the operation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Randomised, Prospective, Multicentre, Parallel-group Trial to Compare Efficacy and Safety of TachoComb S Versus Standard Surgical Treatment in Patients Undergoing Surgical Resection of Superficial Renal Tumour.
The overall objective is to compare efficacy and safety of TachoComb S and standard surgical treatment for the control of local bleeding in patients undergoing surgical resection of renal tumours. Specific objectives include the comparison between test treatments of intra-operative haemostatic efficacy as well as post-operative blood loss, haematoma formation, and surgeon's rating of usefulness of test treatment.
- Being tested
- Fibrinogen (human) + thrombin (human) (TachoSil)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen (human) + thrombin (human) (TachoSil)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint is overall time to intraoperative haemostasis from start of test treatment until haemostasis is obtained following 1 or 2 rounds of randomised treatment,and other haemostatic treatment, if necessary.
Secondary outcomes (2)
Secondary efficacy endpoints are: 1) proportion of patients with haemostasis 10 minutes after start of test treatment; 2) haematoma formation on day 2 after surgery (sonography).
Adverse events will be recorded from screening until follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Resection of Superficial Renal TumourStudies 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
- 170 participants
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Please refer to this study by ClinicalTrials.gov identifier NCT00241163, Nycomed, Study chair, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241163
- Sponsor's protocol ID
- TC-015-IN
- Status last verified
- May 2012
- First submitted
- 16 Oct 2005
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomised, Prospective, Multicentre, Parallel-group Trial to Compare Efficacy and Safety of TachoComb S Versus Standard Surgical Treatment in Patients Undergoing Surgical Resection of Superficial Renal Tumour.
- ClinicalTrials.gov ID
- NCT00241163
- Acronym / sponsor ID
- TC-015-IN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- First posted
- 18 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective is to compare efficacy and safety of TachoComb S and standard surgical treatment for the control of local bleeding in patients undergoing surgical resection of renal tumours. Specific objectives include the comparison between test treatments of intra-operative haemostatic efficacy as well as post-operative blood loss, haematoma formation, and surgeon's rating of usefulness of test treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients of or above 18 years of age scheduled for resection of superficial tumour on the kidney and scheduled for open surgery. After the tumour resection the wound should be suitable for the treatments in the study, and the integrity of the urinary tract should be maintained.
Key exclusion criteria (1 listed)
- Patients undergoing an emergency operation, or with more than one tumour will be excluded. Patients with a clinically abnormal value of prothrombin time or activated partial thromboplastin time, anamnetic evidence of coagulation disorders and a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen will be excluded. In case the tumour was resected by use of a laser scalpel, infrared coagulator or argon beamer and if any fibrin glue haemostatic was used before randomisation the patient will be excluded from the trial. Furthermore, patients will be excluded if extensive resection/extirpation of the kidney become necessary or in case of serious surgical complication occurring during the operation.
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 |
|---|---|---|
| Fibrinogen (human) + thrombin (human) (TachoSil) | Procedure or surgery | – |
Primary outcome
Primary efficacy endpoint is overall time to intraoperative haemostasis from start of test treatment until haemostasis is obtained following 1 or 2 rounds of randomised treatment,and other haemostatic treatment, if necessary.
2 secondary outcomes
Secondary efficacy endpoints are: 1) proportion of patients with haemostasis 10 minutes after start of test treatment; 2) haematoma formation on day 2 after surgery (sonography).
Adverse events will be recorded from screening until follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2012.
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.
Please refer to this study by ClinicalTrials.gov identifier NCT00241163, Nycomed study chair
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrinogen (human) + thrombin (human) (TachoSil) in people with Surgical Resection of Superficial Renal Tumour, run by Takeda at 1 site in Denmark.
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 1 inclusion and 1 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 3 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary efficacy endpoint is overall time to intraoperative haemostasis from start of test treatment until haemostasis is obtained following 1 or 2 rounds of randomised treatment,and other haemostatic treatment, if necessary.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2012.