Non-Interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE) - Full Text View

Sponsored by:	Nycomed
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00546169

Purpose

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.

Condition	Intervention
Hemorrhage	Drug: Fibrinogen (human) + thrombin (human) (TachoSil)

Drug Information available for: TachoSil

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Non-Interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)

Further study details as provided by Nycomed:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	June 2007
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: Fibrinogen (human) + thrombin (human) (TachoSil) haemorrhages in cholecystectomy

Eligibility

Study Population

care clinic

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546169

Locations

Sponsors and Collaborators

Nycomed

Investigators

Study Chair:

Nycomed Clinical Trial Operations

Headquaters

More Information

Responsible Party:	Clinical Trial Operations ( Nycomed )
Study ID Numbers:	TC-027-DE
Study First Received:	October 17, 2007
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00546169
Health Authority:	Germany: Ethics Commission

Keywords provided by Nycomed:

Patients undergoing elective or acute cholecystectomy

Study placed in the following topic categories:

Thrombin
Hemorrhage

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009