Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)
NCT ID: NCT00546169
Last Updated: 2012-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2007-06-30
2008-07-31
Brief Summary
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* Evaluation of TachoSil in laparoscopic cholecystectomy
* Risk profile of patient under anticoagulant therapy undergoing acute cholecystectomy
* Pharmaco-economic evaluation
* Recording of AE's/SAE's Considering the total number of cholecystectomies in Germany (170.000 cases/y), out of them about 75% laparoscopic and 10.000 conversions totally it seems urgent to record data about usage of TachoSil in such procedures. For the time being TachoSil is applied in about 2% of the gall bladder procedures.
Aim is to evaluate a possible patient and procedure profile where TachoSil is most beneficial.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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A
Fibrinogen (human) + thrombin (human) (TachoSil)
haemorrhages in cholecystectomy
Interventions
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Fibrinogen (human) + thrombin (human) (TachoSil)
haemorrhages in cholecystectomy
Eligibility Criteria
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Inclusion Criteria
* The only restrictions of use will be those resulting from the contraindications (see section 4.3 of the Summary of Product Characteristics)
18 Years
ALL
No
Sponsors
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Nycomed
INDUSTRY
Responsible Party
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Clinical Trial Operations
Principal Investigators
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Nycomed Clinical Trial Operations
Role: STUDY_CHAIR
Headquaters
Locations
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Nycomed
Roskilde, , Denmark
Countries
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Other Identifiers
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TC-027-DE
Identifier Type: -
Identifier Source: org_study_id
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