Blood Loss, SurgicalNCT00285623

Observational Cohort Study of TachoSil (TC-018-IN)

An observational study of Blood Loss, Surgical, run by Nycomed at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to collect information, after exposure to TachoSil ®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding. In addition, pharmacoeconomic data will be collected. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Blood Loss, Surgical
What is being tested?: Fibrinogen (human) + thrombin (human) (TachoSil)
How many people: 3,000 participants
Where: 1 siteDenmark
Study dates: Dec 2005to Jul 2008
Phase: Observational
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

Study population: Patients exposed to TachoSil® of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding.

Who may be able to join

All subjects, treated with TachoSil ® by the participating physicians, will be registered with a set of basic data from their already existing data (i.e. no additional diagnostic procedures will be performed).
Subjects who will provide their written informed consent to use existing data, allow direct access to data and data processing.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Nycomed
Roskilde, 4000

Other trials in Denmark

About this study

Official title: An Non-interventional, Prospective, Non-controlled Study of the Use of TachoSil in Supportive Treatment in Surgery for Improvement of Haemostasis Where Standard Techniques Are Insufficient.

Conditions: Blood Loss, Surgical
Being tested: Fibrinogen (human) + thrombin (human) (TachoSil)
Keywords: Collection of all thromboembolic events,, immunological events and drug interactions leading to thromboembolic events or major, bleeding after exposure to TachoSil®.
Medical subject headings: Blood Loss, Surgical

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
treatment in surgery for improvement of haemostasis where standard techniques are insufficient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005Jul 2008

First posted2 Feb 2006 (estimated)
Study startDec 2005
Primary completionApr 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Blood Loss, SurgicalStudies 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 3,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00285623
Sponsor's protocol ID: TC-018-IN
Status last verified: Jul 2009
First submitted: 21 Dec 2005
Last updated: 7 May 2012
Results posted: No
Data monitoring committee: Yes

Publications

Birth M, Figueras J, Bernardini S, Troen T, Gunther K, Mirza D, Mortensen FV. Collagen fleece-bound fibrin sealant is not associated with an increased risk of thromboembolic events or major bleeding after its use for haemostasis in surgery: a prospective multicentre surveillance study. Patient Saf Surg. 2009 Jun 22;3(1):13. doi: 10.1186/1754-9493-3-13.
PubMed 19545437

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
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All Blood Loss, Surgical trials

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 Non-interventional, Prospective, Non-controlled Study of the Use of TachoSil in Supportive Treatment in Surgery for Improvement of Haemostasis Where Standard Techniques Are Insufficient.
ClinicalTrials.gov ID: NCT00285623
Acronym / sponsor ID: TC-018-IN
Conditions: Blood Loss, Surgical
Keywords: Collection of all thromboembolic events,, immunological events and drug interactions leading to thromboembolic events or major, bleeding after exposure to TachoSil®.
Study type: Observational
Recruitment status: Completed
Enrolment: 3,000 participants (actual)
Lead sponsor: NycomedIndustry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: Apr 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 2 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.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients exposed to TachoSil® of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding.

Key inclusion criteria (2 listed)

All subjects, treated with TachoSil ® by the participating physicians, will be registered with a set of basic data from their already existing data (i.e. no additional diagnostic procedures will be performed).
Subjects who will provide their written informed consent to use existing data, allow direct access to data and data processing.

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)treatment in surgery for improvement of haemostasis where standard techniques are insufficient	Drug	–

Primary outcome

Not reported in the source record.

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.
Derived from this study: PubMed 19545437Birth M, Figueras J, Bernardini S, Troen T, Gunther K, Mirza D, Mortensen FV. Collagen fleece-bound fibrin sealant is not associated with an increased risk of thromboembolic events or major bleeding after its use for haemostasis in surgery: a prospective multicentre surveillance study. Patient Saf Surg. 2009 Jun 22;3(1):13. doi: 10.1186/1754-9493-3-13.

Related trials for Blood Loss, Surgical

Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps

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?

An observational study of Blood Loss, Surgical, 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 2 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.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00285623, 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 7 May 2012.