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Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)

This study has been completed.
Information provided by:
Nycomed Identifier:
First received: October 17, 2007
Last updated: May 4, 2012
Last verified: August 2008
  • Effectiveness and reliability of TachoSil in cholecystectomy (elective and acute)
  • 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.

Condition Intervention
Drug: Fibrinogen (human) + thrombin (human) (TachoSil)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)

Resource links provided by NLM:

Further study details as provided by Nycomed:

Estimated Enrollment: 500
Study Start Date: June 2007
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: Fibrinogen (human) + thrombin (human) (TachoSil)
haemorrhages in cholecystectomy


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
care clinic

Inclusion Criteria:

  • Patients undergoing elective or acute cholecystectomy
  • The only restrictions of use will be those resulting from the contraindications (see section 4.3 of the Summary of Product Characteristics)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00546169

Roskilde, Denmark, 4000
Sponsors and Collaborators
Study Chair: Nycomed Clinical Trial Operations Headquaters
  More Information

Responsible Party: Nycomed, Clinical Trial Operations Identifier: NCT00546169     History of Changes
Other Study ID Numbers: TC-027-DE
Study First Received: October 17, 2007
Last Updated: May 4, 2012

Keywords provided by Nycomed:
Patients undergoing elective or acute cholecystectomy

Additional relevant MeSH terms:
Pathologic Processes
Coagulants processed this record on May 24, 2017