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

NCT00546169 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2012-05-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Fibrinogen (human) + thrombin (human) (TachoSil)

haemorrhages in cholecystectomy

Sponsors & Collaborators

  • Nycomed

    lead INDUSTRY

Principal Investigators

  • Nycomed Clinical Trial Operations · Headquaters

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-06-30
Completion
2008-07-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00546169 on ClinicalTrials.gov