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

Nycomed

Status: Completed

Conditions: Hemorrhage

Treatments: Drug: Fibrinogen (human) + thrombin (human) (TachoSil)

Study type: Observational

Funder types: Industry

Identifiers

NCT00546169

TC-027-DE

Details and patient eligibility

About

• 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

500 participants in 1 patient group

A

Treatment:

Drug: Fibrinogen (human) + thrombin (human) (TachoSil)