Hypercoagulable StatesNCT04565977
Evaluating Off-label Use of Direct Oral Anticoagulants (DOACs) in Hypercoagulable States
An observational study of Hypercoagulable States, run by Methodist Health System at 1 site in United States.
Trial summary
Retrospective, cohort study chart review in patients with hypercoagulable states. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercoagulable States
- What is being tested?
- Observational
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 10 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hypercoagulable states identified by ICD-9/ICD-10 codes from January 1st, 2015 to December 31st, 2019
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Retrospective, cohort study chart review in patients with hypercoagulable states.
Read the 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
- Conditions
- Hypercoagulable States
- Being tested
- Observational
- Medical subject headings
- Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Retrospective chart review
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | All patients with hypercoagulable states identified by ICD-9/ICD-10 codes from January 1st, 2015 to December 31st, 2019 Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of thrombotic events during the study period
Rates of thrombotic events during the study period
Measured: Jan 1,2015 - Dec 31st, 2019
Rates of hemorrhagic events during the study period
Rates of hemorrhagic events during the study period
Measured: Jan 1,2015 - Dec 31st, 2019
Secondary outcomes (1)
Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states
Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states
Measured: Jan 1,2015 - Dec 31st, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Jul 2020
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercoagulable StatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie Vuylsteke, PharmD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565977
- Sponsor's protocol ID
- 042.PHA.2020.A
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2020
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Off-label Use of Direct Oral Anticoagulants (DOACs) in Hypercoagulable States
- ClinicalTrials.gov ID
- NCT04565977
- Acronym / sponsor ID
- 042.PHA.2020.A
- Conditions
- Hypercoagulable States
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | Other: ObservationalAll patients with hypercoagulable states identified by ICD-9/ICD-10 codes from January 1st, 2015 to December 31st, 2019 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hypercoagulable states identified by ICD-9/ICD-10 codes from January 1st, 2015 to December 31st, 2019
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalRetrospective chart review | Other | Retrospective Cohort |
Primary outcome
Rates of thrombotic events during the study period
Time frame: Jan 1,2015 - Dec 31st, 2019
Rates of thrombotic events during the study period
Rates of hemorrhagic events during the study period
Time frame: Jan 1,2015 - Dec 31st, 2019
Rates of hemorrhagic events during the study period
1 secondary outcome
Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states
Time frame: Jan 1,2015 - Dec 31st, 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Hypercoagulable States
Active, not recruitingObservational study
An Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related
Sepsis, Venous Thromboembolism
Not yet recruiting
Effects of Sweetener Consumption on Risk Factors for Heart Disease in Prediabetic Subjects
Prediabetic State, Metabolic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Vuylsteke, PharmD principal investigator
Methodist Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercoagulable States, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of thrombotic events during the study period (time frame: Jan 1,2015 - Dec 31st, 2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.