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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Blood Loss, Surgical

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No