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

May 4, 2012 updated by: Nycomed
  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Nycomed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

care clinic

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: Fibrinogen (human) + thrombin (human) (TachoSil)
haemorrhages in cholecystectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nycomed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

October 17, 2007

First Submitted That Met QC Criteria

October 17, 2007

First Posted (Estimate)

October 18, 2007

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC-027-DE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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