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Completed

NCT Number: NCT04565977

Evaluating Off-label Use of Direct Oral Anticoagulants (DOACs) in Hypercoagulable States

Retrospective, cohort study chart review in patients with hypercoagulable states.

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Key information

Conditions

Hypercoagulable States Hematologic Diseases Hemic and Lymphatic Diseases Thrombophilia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

  • Retrospective, cohort study chart review in patients at Methodist Health System
  • Data will be pulled on all patients with hypercoagulable states identified by ICD-9/ICD-10 codes from January 1st, 2015 to December 31st, 2019

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 18 year-old
  • Patients with diagnosis of hypercoagulable state identified by ICD-9/ICD-10 codes
  • Patients who were prescribed DOACs or VKA for primary or secondary prevention of thrombosis

Exclusion criteria

  • Patients with FDA-approved indications of oral anticoagulants including atrial fibrillation or treatment/prevention of thrombotic events unrelated to specified hypercoagulable states
  • Patients with incomplete electronic medical records

Treatment and study plan

Observational

Other

Retrospective chart review

Primary outcomes

  1. Rates of thrombotic events during the study period

    Time frame: Jan 1,2015 - Dec 31st, 2019

    Rates of thrombotic events during the study period

  2. Rates of hemorrhagic events during the study period

    Time frame: Jan 1,2015 - Dec 31st, 2019

    Rates of hemorrhagic events during the study period

Secondary outcomes

  1. Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states

    Time frame: Jan 1,2015 - Dec 31st, 2019

    Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2020
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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