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

Completed

• Conditions: Hypercoagulable States
• Interventions: Other: Observational

• Registration Number: NCT04565977
• Lead Sponsor: Methodist Health System

Brief Summary

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

Detailed Description

* 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

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Primary Completion: 2021-06-10
• Study Completion: 2021-06-10
• Status Verified: 2024-09
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective Cohort	Observational	All patients with hypercoagulable states identified by ICD-9/ICD-10 codes from January 1st, 2015 to December 31st, 2019

Primary Outcome Measures

Name	Time	Method
Rates of hemorrhagic events during the study period	Jan 1,2015 - Dec 31st, 2019	Rates of hemorrhagic events during the study period
Rates of thrombotic events during the study period	Jan 1,2015 - Dec 31st, 2019	Rates of thrombotic events during the study period

Secondary Outcome Measures

Name	Time	Method
Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states	Jan 1,2015 - Dec 31st, 2019	Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States