Control of Local Bleeding in Patients Undergoing Prostatectomy.Phase 4NCT00290836
Assess Efficacy and Safety of TachoComb H vs. Standard Surgical Treatment (i.e. Suturing) in Patients Undergoing Prostatectomy (TC-017-AU)
A Phase 4 study testing Human fibrinogen/thrombin and bovine aprotinin (TachoComb H) in people with Control of Local Bleeding in Patients Undergoing Prostatectomy., run by Nycomed at 1 site in Denmark.
Trial summary
The overall objective is to compare efficacy and safety of TachoComb H versus standard surgical treatment for the control of local bleeding in patients undergoing prostatectomy. Specific objectives include the comparison between test treatments for intraoperative haemostatic efficacy as well as for post-operative… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Control of Local Bleeding in Patients Undergoing Prostatectomy.
- What is being tested?
- Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- May 2004to Aug 2007
- Phase
- Phase 4
- 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
- has the subject given informed consent according to local requirements before any trial related activies? A trial related activity is any procedure that would not have been performed during the routine management of the subject.
- Is the subject 18 years of age or above ?
- Is the subject planned for a radical prostatectomy for prostate cancer (cT3)?
- After prostate resection and primary haemostatic treatment
- is only minor (i.e. oozing) or moderate haemorrhage persisting after primary surgical haemostatic procedures of the major vessels (no pulsating arterial haemorrhage and/or major venous bleeding)?
Who cannot join
- At pre-operative screen
- Is there anamnestic or laboratory evidence of coagulation disorders including haemophilia A or B and von Willebrand disease ?
- Has the patient a history of allergic reactions after application of human fibrinogen, human thrombin, bovine aprotinin and/or collagen of any origin?
- Is the patient undergoing an emergency operation?
- Did the patient participate in a clinical trial less than 30 days prior to inclusion in present trial?
- Does the patient participate in a clinical trial concomitantly with present trial?
Show all 9Show fewer
- After tumour resection and primary haemostatic treatment
- Has any serious surgical complication occurred?
- Has any fibrin glue haemostatic (including any type of TachoComb) been used before randomisation?
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Randomised, Prospective, Single-centre Phase IV Trial to Assess Efficacy and Safety of TachoComb H Versus Standard Surgical Treatment (i.e. Suture) in Patients Undergoing Prostatectomy
The overall objective is to compare efficacy and safety of TachoComb H versus standard surgical treatment for the control of local bleeding in patients undergoing prostatectomy. Specific objectives include the comparison between test treatments for intraoperative haemostatic efficacy as well as for post-operative blood loss to be assessed by haemoglobin and haematocrit concentration of drainage fluid.
- Being tested
- Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Is the percentage of patients/treatment group in which efficient intra-operative haemostasis is achieved within 10 minutes after applying test treatment according to randomisation after primary surgical haemostasis.
Secondary outcomes (7)
Efficacy:
Haemoglobin concentration of drainage fluid on day 1 after surgery.
Haemotocrit concentration of drainage fluid on day 1 after surgery.
Volume of drainage fluid on day 1 after surgery.
Incidence of post-operative haematoma at removal site at day 2 after surgery (sonography).
Incidence of tumour positive resection margin proven by histology (discharge).
Reporting of occurrence of urinary incontinence (discharge, 3 months +/- 10 days (and optional 12 months +/- 30 days) after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startMay 2004
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Control of Local Bleeding in Patients Undergoing Prostatectomy.Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Nycomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nycomed Clinical Trial Operations, Study chair, Headquaters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290836
- Sponsor's protocol ID
- TC-017-AU
- Status last verified
- May 2012
- First submitted
- 16 Dec 2005
- 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, Single-centre Phase IV Trial to Assess Efficacy and Safety of TachoComb H Versus Standard Surgical Treatment (i.e. Suture) in Patients Undergoing Prostatectomy
- ClinicalTrials.gov ID
- NCT00290836
- Acronym / sponsor ID
- TC-017-AU
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- NycomedIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Aug 2007 (actual)
- First posted
- 13 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 overall objective is to compare efficacy and safety of TachoComb H versus standard surgical treatment for the control of local bleeding in patients undergoing prostatectomy. Specific objectives include the comparison between test treatments for intraoperative haemostatic efficacy as well as for post-operative blood loss to be assessed by haemoglobin and haematocrit concentration of drainage fluid.
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 (5 listed)
- has the subject given informed consent according to local requirements before any trial related activies? A trial related activity is any procedure that would not have been performed during the routine management of the subject.
- Is the subject 18 years of age or above ?
- Is the subject planned for a radical prostatectomy for prostate cancer (cT3)?
- After prostate resection and primary haemostatic treatment
- is only minor (i.e. oozing) or moderate haemorrhage persisting after primary surgical haemostatic procedures of the major vessels (no pulsating arterial haemorrhage and/or major venous bleeding)?
Key exclusion criteria (9 listed)
- At pre-operative screen
- Is there anamnestic or laboratory evidence of coagulation disorders including haemophilia A or B and von Willebrand disease ?
- Has the patient a history of allergic reactions after application of human fibrinogen, human thrombin, bovine aprotinin and/or collagen of any origin?
- Is the patient undergoing an emergency operation?
- Did the patient participate in a clinical trial less than 30 days prior to inclusion in present trial?
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 |
|---|---|---|
| Human fibrinogen/thrombin and bovine aprotinin (TachoComb H) | Drug | – |
Primary outcome
Efficacy: Is the percentage of patients/treatment group in which efficient intra-operative haemostasis is achieved within 10 minutes after applying test treatment according to randomisation after primary surgical haemostasis.
7 secondary outcomes
Efficacy:
Haemoglobin concentration of drainage fluid on day 1 after surgery.
Haemotocrit concentration of drainage fluid on day 1 after surgery.
Volume of drainage fluid on day 1 after surgery.
Incidence of post-operative haematoma at removal site at day 2 after surgery (sonography).
Incidence of tumour positive resection margin proven by histology (discharge).
Reporting of occurrence of urinary incontinence (discharge, 3 months +/- 10 days (and optional 12 months +/- 30 days) after surgery.
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.
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
Headquaters
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human fibrinogen/thrombin and bovine aprotinin (TachoComb H) in people with Control of Local Bleeding in Patients Undergoing Prostatectomy., 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 5 inclusion and 9 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Efficacy: Is the percentage of patients/treatment group in which efficient intra-operative haemostasis is achieved within 10 minutes after applying test treatment according to randomisation after primary surgical haemostasis.. 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.