NCT04565977

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
Last Updated

November 20, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

September 22, 2020

Last Update Submit

November 18, 2024

Conditions

Hypercoagulable States

Outcome Measures

Primary Outcomes (2)

  • Rates of thrombotic events during the study period

    Rates of thrombotic events during the study period

    Jan 1,2015 - Dec 31st, 2019

  • Rates of hemorrhagic events during the study period

    Rates of hemorrhagic events during the study period

    Jan 1,2015 - Dec 31st, 2019

Secondary Outcomes (1)

  • Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states

    Jan 1,2015 - Dec 31st, 2019

Study Arms (1)

Retrospective Cohort

All patients with hypercoagulable states identified by ICD-9/ICD-10 codes from January 1st, 2015 to December 31st, 2019

Other: Observational

Interventions

ObservationalOTHER

Retrospective chart review

Retrospective Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hypercoagulable states identified by ICD-9/ICD-10 codes from January 1st, 2015 to December 31st, 2019

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Thrombophilia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Valerie Vuylsteke, PharmD

    Methodist Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2020

First Posted

September 28, 2020

Study Start

July 1, 2020

Primary Completion

June 10, 2021

Study Completion

June 10, 2021

Last Updated

November 20, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)