Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)
This study has been completed.
Information provided by:
First received: October 17, 2007
Last updated: May 4, 2012
Last verified: August 2008
- 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 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:
|Study Start Date:||June 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Drug: Fibrinogen (human) + thrombin (human) (TachoSil)
haemorrhages in cholecystectomy
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