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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03050138
Date of registration: 08/02/2017
Prospective Registration: No
Primary sponsor: Oslo University Hospital
Public title: Prevalence of Post-Thrombotic Syndrome in Deep-Vein Thrombosis (DVT) Patients Treated With Dabigatran DABI-PTS
Scientific title: The Prevalence of Post-Thrombotic Syndrome in Deep-Vein Thrombosis (DVT) Patients Treated With Dabigatran- a Cross-Sectional Assessment of RE-COVER Study Patients
Date of first enrolment: April 2016
Target sample size: 351
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03050138
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Canada Norway Sweden
Contacts
Name:     Hilde S Wik, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Oslo University Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients with DVT (±PE) treated in the RE-COVER studies.

2. Signed written informed consent.

Exclusion Criteria:

1. Patients who refuse to participate

2. Deceased patients



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Postthrombotic Syndrome
Intervention(s)
Primary Outcome(s)
Post-thrombotic syndrome (PTS) [Time Frame: April 2016 - December 2017]
Secondary Outcome(s)
Post-thrombotic syndrome (PTS) determined by the standard Villalta score [Time Frame: April 2016 - December 2017]
Recurrent venous thromboembolism [Time Frame: April 2016 - December 2017]
Disease specific health related Quality of Life (HRQoL) [Time Frame: April 2016 - December 2017]
Generic health related Quality of Life (HRQoL) [Time Frame: April 2016 - December 2017]
Secondary ID(s)
2014/151
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Jewish General Hospital
Ostfold Hospital Trust
McMaster University
Vestre Viken Hospital Trust
Sahlgrenska University Hospital, Sweden
St. Olavs Hospital
Kristianstad University
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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