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

• Sponsor: Nycomed (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00546169
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 38.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhage	Drug: Fibrinogen (human) + thrombin (human) (TachoSil)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
A	Drug: Fibrinogen (human) + thrombin (human) (TachoSil); haemorrhages in cholecystectomy

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Nycomed	Roskilde		Denmark	4000

Sponsors and Collaborators

• Nycomed

Investigators

• Study Chair: Nycomed Clinical Trial Operations, Headquaters

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00546169
• Other Study ID Numbers: TC-027-DE
• First Posted: Oct 18, 2007
• Last Update Posted: May 7, 2012
• Last Verified: Aug 1, 2008

• Keywords provided by , ,: Patients undergoing elective or acute cholecystectomy
• Additional relevant MeSH terms: Hemorrhage; Thrombin

Study Results

No Results Posted as of May 7, 2012