Pulmonary DiseasesPhase 3NCT00293514
TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)
A Phase 3 study testing Fibrinogen (human) + thrombin (human) (TachoSil) in people with Pulmonary Diseases and Intraoperative Complications, run by Nycomed at 1 site in Denmark.
Trial summary
The purpose of this study is to compare the sealing efficacy and safety of TachoSil® (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung malignancies with or without metastases. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Diseases, Intraoperative Complications
- What is being tested?
- Fibrinogen (human) + thrombin (human) (TachoSil)
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Feb 2006to Oct 2007
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a diagnosis of lung malignancy with or without metastases may be included in the trial if the entry criteria apply.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Randomised, Prospective, Multi-centre, Parallel-group Trial of TachoSil Versus Standard Surgical Treatment in Patients Undergoing Pulmonary Lobectomy for Lung Malignancy and Requiring Treatment for Air Leakage
The purpose of this study is to compare the sealing efficacy and safety of TachoSil® (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung malignancies with or without metastases.
- Conditions
- Pulmonary Diseases, Intraoperative Complications
- Being tested
- Fibrinogen (human) + thrombin (human) (TachoSil)
- Keywords
- standard surgical treatment for air leakage in pulmonary lobectomy
- Medical subject headings
- Lung Diseases, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen (human) + thrombin (human) (TachoSil)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of post-operative air leakage: assessment on the evening of the day of operation (Day 0) and then subsequently twice daily (on morning and evening shifts)
Secondary outcomes (1)
Reduction of intra-operative air leakage intensity after first application of trial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Nycomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nycomed Clinical Trial Operations, Study chair, Headquarters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293514
- Sponsor's protocol ID
- TC-021-IM
- Other IDs
- 2004-002380-24, 2004
- Status last verified
- Feb 2008
- First submitted
- 15 Feb 2006
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomised, Prospective, Multi-centre, Parallel-group Trial of TachoSil Versus Standard Surgical Treatment in Patients Undergoing Pulmonary Lobectomy for Lung Malignancy and Requiring Treatment for Air Leakage
- ClinicalTrials.gov ID
- NCT00293514
- Acronym / sponsor ID
- TC-021-IM
- Conditions
- Pulmonary Diseases, Intraoperative Complications
- Keywords
- standard surgical treatment for air leakage in pulmonary lobectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- NycomedIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 17 Feb 2006 (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 purpose of this study is to compare the sealing efficacy and safety of TachoSil® (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung malignancies with or without metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with a diagnosis of lung malignancy with or without metastases may be included in the trial if the entry criteria apply.
Key exclusion criteria (0 listed)
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) | Drug | – |
Primary outcome
Duration of post-operative air leakage: assessment on the evening of the day of operation (Day 0) and then subsequently twice daily (on morning and evening shifts)
1 secondary outcome
Reduction of intra-operative air leakage intensity after first application of trial treatment
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 7 May 2012.
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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.
Nycomed Clinical Trial Operations study chair
Headquarters
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 Pulmonary Diseases and Intraoperative Complications, run by Nycomed 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 0 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 7 May 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?
Duration of post-operative air leakage: assessment on the evening of the day of operation (Day 0) and then subsequently twice daily (on morning and evening shifts). 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 7 May 2012.