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NCT00546169 Clinical Trial

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

Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00546169
Other study ID # TC-027-DE
Secondary ID
Status Completed
Phase N/A
First received October 17, 2007
Last updated May 4, 2012
Start date June 2007
Est. completion date July 2008

Study information
Verified date August 2008
Source Nycomed
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

- 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.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date July 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Fibrinogen (human) + thrombin (human) (TachoSil)
haemorrhages in cholecystectomy

Locations
Country Name City State
Denmark Nycomed Roskilde

Sponsors (1)
Lead Sponsor Collaborator
Nycomed

Country where clinical trial is conducted

Denmark, 

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