Trials / Completed
CompletedNCT00546169
Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Nycomed · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fibrinogen (human) + thrombin (human) (TachoSil) | haemorrhages in cholecystectomy |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2008-06-01
- Completion
- 2008-07-01
- First posted
- 2007-10-18
- Last updated
- 2012-05-07
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00546169. Inclusion in this directory is not an endorsement.