Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Venous Thromboembolism
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 15 years and 49 years
Gender
Only males

Description

This population-based case-control study will be conducted in Germany and Austria. It is intended to recruit the VTE cases from the primary care sector (i.e. community based) before referral to specialized centers/hospitals, from hospitals (emergency department or internal medicine ward) or when the...

This population-based case-control study will be conducted in Germany and Austria. It is intended to recruit the VTE cases from the primary care sector (i.e. community based) before referral to specialized centers/hospitals, from hospitals (emergency department or internal medicine ward) or when the cases are referred back to ambulatory care after diagnosis and initiation of treatment in hospital settings or specialized diagnostic centers. Cases will be prospectively included if they are diagnosed with a new venous thrombotic event after study start. Controls will be accrued as soon as cases are identified to match with. The index date for controls is the date of the event in the matched cases, i.e. information after this index date is dismissed in the analyses. Matching will be based on year of birth, sex and region of residence. In addition, all controls have to be either current COC users or recent past users (non-use for 3 months or less). The recruitment of matched controls will be stopped as soon as 4 matched controls have been identified that are current new or incident users of a CMA or LNG COC in the pre-defined dosage (as defined as primary exposure).

Tracking Information

NCT #
NCT02828904
Collaborators
Not Provided
Investigators
Not Provided