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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00546169
First Posted: October 18, 2007
Last Update Posted: May 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nycomed
  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:


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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546169


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

Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov Identifier: NCT00546169     History of Changes
Other Study ID Numbers: TC-027-DE
First Submitted: October 17, 2007
First Posted: October 18, 2007
Last Update Posted: May 7, 2012
Last Verified: August 2008

Keywords provided by Nycomed:
Patients undergoing elective or acute cholecystectomy

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Thrombin
Hemostatics
Coagulants