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

This study has been completed.
Sponsor:
Information provided by:
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00546169
First received: October 17, 2007
Last updated: May 4, 2012
Last verified: August 2008
History of Changes
  Purpose
  • 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
Hemorrhage
 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:

U.S. FDA Resources

Further study details as provided by Nycomed: A Takeda Company:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

care clinic

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00546169

Locations
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nycomed: A Takeda Company
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquaters
  More Information

No publications provided

Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov Identifier: NCT00546169     History of Changes
Other Study ID Numbers: TC-027-DE
Study First Received: October 17, 2007
Last Updated: May 4, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Nycomed: A Takeda Company:
Patients undergoing elective or acute cholecystectomy

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013