Observational Cohort Study of TachoSil (TC-018-IN)

Blood Loss, Surgical Clinical Trial

Official title:

An Non-interventional, Prospective, Non-controlled Study of the Use of TachoSil in Supportive Treatment in Surgery for Improvement of Haemostasis Where Standard Techniques Are Insufficient.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285623
• Other study ID #: TC-018-IN
• Status: Completed
• Phase: Phase 4
• First received: December 21, 2005
• Last updated: May 4, 2012
• Start date: December 2005
• Est. completion date: July 2008

Study information

• Verified date: July 2009
• Source: Nycomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenBelgium: Federal Agency for Medicines and Health Products, FAMHPDenmark: Danish Medicines AgencyFrance: Ministry of HealthGermany: Paul-Ehrlich-InstitutGreece: National Organization of MedicinesNetherlands: Medicines Evaluation Board (MEB)Norway: Norwegian Medicines AgencySweden: Medical Products AgencySwitzerland: SwissmedicUnited Kingdom: National Health ServiceSpain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect information, after exposure to TachoSil ®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding. In addition, pharmacoeconomic data will be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: July 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• All subjects, treated with TachoSil ® by the participating physicians, will be registered with a set of basic data from their already existing data (i.e. no additional diagnostic procedures will be performed).

• Subjects who will provide their written informed consent to use existing data, allow direct access to data and data processing.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Loss, Surgical

Intervention

Drug:
• Fibrinogen (human) + thrombin (human) (TachoSil)
treatment in surgery for improvement of haemostasis where standard techniques are insufficient

Locations

Country	Name	City	State
Denmark	Nycomed	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Nycomed

Country where clinical trial is conducted

Denmark,