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

* 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.

Completed

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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nycomed

Roskilde, 4000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fibrinogen (human) + thrombin (human) (TachoSil)

Drug

haemorrhages in cholecystectomy

Sponsors and collaborators

Lead sponsor

Nycomed

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Oct 18, 2007
Registry last updated: May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed