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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00285623

Enrollment

3000

Registered

2006-02-02

Start date

2005-12-31

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

Blood Loss, Surgical

Keywords

Collection of all thromboembolic events,, immunological events and drug interactions leading to thromboembolic events or major, bleeding after exposure to TachoSil®.

Brief 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.

Interventions

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

treatment in surgery for improvement of haemostasis where standard techniques are insufficient

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026