Description of Patients With Acute Venous Thromboembolism in the UK's Clinical Practice Research Datalink Linked With Hospital Episode Statistics Dataset (CPRD-HES)

Anticoagulation Treatment Patterns and Persistence After Acute Venous Thromboembolism in the UK in Routine Clinical Practice: A Retrospective Database Study of the Clinical Practice Research Datalink and the Hospital Episode Statistics Dataset

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02661568

Enrollment

38409

Registered

2016-01-22

Start date

2014-09-30

Completion date

2015-12-31

Last updated

2016-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Brief summary

This study will utilize a retrospective cohort design. Using the Clinical Practice Research Datalink (CPRD) linked with Hospital Episode Statistics (HES) datasets, all patients with a record of VTE diagnosis between 1 April, 2008 and 31 March, 2013 will be identified and followed from the occurrence of VTE (index date) to the first of 24 months after the index date, end of the study period, leaving the database, or death.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

VTE events will be included if: * they are identified by at least one Read code diagnosis of acute VTE in the CPRD, or one ICD-10 code of VTE in the HES database, during the study period; and * they occurred in patients ≥ 18 years old at time of VTE occurrence; and * CPRD acceptability quality criteria are present

Exclusion criteria

VTE events will be excluded if: * Patients have fewer than 12 months of computerized data available prior to VTE occurrence. The date of start of computerized records will be the latter of the patient's date of current registration with the practice or the practice's Up-to-Standard (UTS) date (date from which practice data is of research quality)

Design outcomes

Primary

Measure	Time frame	Description
Anticoagulation treatment patterns for patients following acute Venous Thromboembolism (VTE) based on all VTE events that occur during the study period	up to 24 months following VTE occurrence	Anticoagulation treatment pattern includes type of anticoagulant (AC), duration of AC treatment, switching between ACs and switching from AC to aspirin or other antiplatelet agents (APA).

Secondary

Measure	Time frame
Demographic characteristics (age, gender) of patients with acute VTE	up to 24 months following VTE occurrence
Clinical characteristics (comorbidities, concomitant treatments, medical and surgical history) of patients with acute VTE	up to 24 months following VTE occurrence
Rates of unplanned (emergency) hospital admission, major surgery, major bleeding, and VTE recurrence	up to 24 months following VTE occurrence
Baseline demographic and clinical characteristics associated with the duration of AC treatment after VTE	up to 24 months following VTE occurrence
Baseline demographic and clinical characteristics associated with novel oral anticoagulant (NOAC) treatment compared with vitamin K antagonist (VKA) treatment following VTE	up to 24 months following VTE occurrence

Outcome results