Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-04-08 @ 3:34 AM
Study NCT ID:
NCT00546169
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2007-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)
Sponsor:
Nycomed
Organization:
Study Overview
Official Title:
Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: