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

Completed

• Conditions: Hemorrhage
• Interventions: Drug: Fibrinogen (human) + thrombin (human) (TachoSil)

• Registration Number: NCT00546169
• Lead Sponsor: Nycomed

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-17
• Study First Posted: 2007-10-18
• Primary Completion: 2008-06
• Study Completion: 2008-07
• Status Verified: 2008-08
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Fibrinogen (human) + thrombin (human) (TachoSil)	-

Trial Locations

Locations (1)

Nycomed; 🇩🇰 Roskilde, Denmark