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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00546169

Enrollment

500

Registered

2007-10-18

Start date

2007-06-30

Completion date

2008-07-31

Last updated

2012-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage

Keywords

Patients undergoing elective or acute cholecystectomy

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.

Interventions

DRUGFibrinogen (human) + thrombin (human) (TachoSil)

haemorrhages in cholecystectomy

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026