HaemorrhagePhase 4NCT00440401
TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM)
A Phase 4 study testing fibrinogen (human) + thrombin (human) and Standard haemostatic treatment in cardiovascular surgery in people with Haemorrhage and Haemostasis, run by Nycomed at 1 site in Denmark.
Trial summary
To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemorrhage, Haemostasis, Cardiovascular Surgery
- What is being tested?
- fibrinogen (human) + thrombin (human) and Standard haemostatic treatment in cardiovascular surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2007to Nov 2007
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All inclusion criteria must be answered "yes" for a subject to participate in the trial.
- At Screening:
- Has the subject given informed consent according to local requirements before any trial related activities? A trial related activity is any procedure that would not have been performed during the routine management of the subject. In this trial the screening is the first trial related activity.
- For female subjects of childbearing potential: Is the pregnancy test at screening negative?
- Does the female subject of childbearing potential use adequate contraception (contraceptive pill, contraceptive injection, contraceptive implant or intrauterine device)?
- Is the subject ≥ 18 years of age?
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- Is the following planned: An elective surgery on the heart, the ascending aorta or arch, requiring cardiopulmonary bypass procedure?
- Intra operative (after primary haemostatic treatment):
- Is bleeding from the heart muscle, the pericardium, a major vessel or a vascular bed that requires supportive haemostatic treatment present?
- Has the area with the most problematic haemorrhage (target area) been identified? (please note that this must be done before randomisation).
- Is it possible to compress the randomised treatment (TachoSil® or control fleece material) for 3 minutes?
Who cannot join
- All exclusion criteria must be answered "no" for a subject to participate in the trial.
- At Screening:
- Has the subject participated in any other trial with an investigational drug or device within 30 days before inclusion in this trial?
- Does the subject participate in a clinical trial concomitantly with the present trial?
- Is the subject undergoing an emergency operation?
- Has the subject a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
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- Is the subject suffering from known coagulopathy?
- Is the subject currently participating or has the subject previously participated in the TC-023-IM trial?
- Is the female subject pregnant or breast feeding?
- Intra operative (after primary haemostatic treatment):
- Has liquid fibrin sealant/glue or TachoSil® been applied?
- Has the following occurred: Disseminated intravascular coagulation (DIC), i.e. micro vascular bleeding?
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Open Label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety of TachoSil® Versus Standard Haemostatic Treatment in Cardiovascular Surgery
To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery
- Conditions
- Haemorrhage, Haemostasis, Cardiovascular Surgery
- Being tested
- fibrinogen (human) + thrombin (human), Standard haemostatic treatment in cardiovascular surgery
- Keywords
- Surgical treatment of haemorrhage
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibrinogen (human) + thrombin (human)Drug
Standard haemostatic treatment in cardiovascular surgeryDrug
Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®)
| Study group | Role | What they receive |
|---|---|---|
| TachoSil® | Active comparator | Not described Receives: Drug: fibrinogen (human) + thrombin (human) |
| Standard Treatment | Active comparator | Standard Treatment of haemorrhage in cardiovascular surgery Receives: Drug: Standard haemostatic treatment in cardiovascular surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Achieving Haemostasis at 3 Minutes
Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.
Measured: 3 minutes
Secondary outcomes (1)
Proportion of Subjects Achieving Haemostasis at 6 Minutes.
Six minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionAug 2007
- Study completionNov 2007
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.
- Other trials for HaemorrhageStudies 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 (actual)
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
- NCT00440401
- Sponsor's protocol ID
- TC-023-IM
- Status last verified
- Jul 2010
- First submitted
- 26 Feb 2007
- Last updated
- 8 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open Label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety of TachoSil® Versus Standard Haemostatic Treatment in Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT00440401
- Acronym / sponsor ID
- TC-023-IM
- Conditions
- Haemorrhage, Haemostasis, Cardiovascular Surgery
- Keywords
- Surgical treatment of haemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- NycomedIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 27 Feb 2007 (estimated)
- Results
- Posted 4 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery
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 | Drug: fibrinogen (human) + thrombin (human) |
| Standard Treatment | Active comparator | Drug: Standard haemostatic treatment in cardiovascular surgeryStandard Treatment of haemorrhage in cardiovascular surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All inclusion criteria must be answered "yes" for a subject to participate in the trial.
- Has the subject given informed consent according to local requirements before any trial related activities? A trial related activity is any procedure that would not have been performed during the routine management of the subject. In this trial the screening is the first trial related activity.
- For female subjects of childbearing potential: Is the pregnancy test at screening negative?
- Does the female subject of childbearing potential use adequate contraception (contraceptive pill, contraceptive injection, contraceptive implant or intrauterine device)?
- Is the subject ≥ 18 years of age?
Key exclusion criteria (12 listed)
- All exclusion criteria must be answered "no" for a subject to participate in the trial.
- Has the subject participated in any other trial with an investigational drug or device within 30 days before inclusion in this trial?
- Does the subject participate in a clinical trial concomitantly with the present trial?
- Is the subject undergoing an emergency operation?
- Has the subject a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
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) | Drug | TachoSil® |
| Standard haemostatic treatment in cardiovascular surgeryAny haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®) | Drug | Standard Treatment |
Primary outcome
Proportion of Subjects Achieving Haemostasis at 3 Minutes
Time frame: 3 minutes
Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.
1 secondary outcome
Proportion of Subjects Achieving Haemostasis at 6 Minutes.
Time frame: 6 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
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 fibrinogen (human) + thrombin (human) and Standard haemostatic treatment in cardiovascular surgery in people with Haemorrhage and Haemostasis, 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 11 inclusion and 12 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 8 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?
Yes. Results are posted in the registry (first posted 4 Jun 2010). 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?
Proportion of Subjects Achieving Haemostasis at 3 Minutes (time frame: 3 minutes). 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 8 May 2012.