Venous ThromboembolismNCT00604370
Retrospective Study to Review Patients at Risk for VTE at Hospital Discharge
An observational study of Venous Thromboembolism, run by Brigham and Women's Hospital.
Trial summary
An investigator initiated study exploring VTE prophylaxis at the time of hospital discharge. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Dec 2011
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acutely ill medical and surgical patients who were hospitalized at BWH and who are at risk for DVT.
Who may be able to join
- Acutely ill medical and surgical patients with a risk score of 4 or greater without prophylaxis or a risk score of 4 or greater with anticoagulation at hospital discharge.
Who cannot join
- None.
About this study
Official title: VTE Prophylaxis Across the Continuum of Care: High Risk Patients at Hospital Discharge
An investigator initiated study exploring VTE prophylaxis at the time of hospital discharge.
Read the detailed description
It appears likely that many patients will remain at risk for VTE at the time of hospital discharge. These risks will go unrecognized, and discharge prophylaxis orders will not be prescribed.
To test this hypothesis, we will perform a retrospective review of approximately 2,500 patients at Brigham and Women's Hospital at risk for VTE at the time of hospital discharge to determine what proportion received VTE prophylaxis. We will correlate the implementation of discharge VTE prophylaxis with the occurrence of symptomatic DVT and pulmonary embolism within 90 days of hospital discharge.
We will also conduct a substudy of this patient population to determine adherence to VTE prophylaxis among hospitalized patients.
- Conditions
- Venous Thromboembolism
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Acutely ill medical and surgical patients who were hospitalized at BWH, and at-risk for VTE, but were not treated with prophylaxis at hospital discharge. | |
| 2 | Acutely ill medical and surgical patients who were at risk for VTE at time of hospital discharge and prescribed a prophylaxis strategy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic PE/DVT within 90 days of hospital discharge.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Samuel Z.Goldhaber, MD, Brigham and Women's Hospital
- Investigators
- Samuel Z Goldhaber, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604370
- Sponsor's protocol ID
- 2006-P-001981
- Status last verified
- Feb 2012
- First submitted
- 28 Dec 2007
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VTE Prophylaxis Across the Continuum of Care: High Risk Patients at Hospital Discharge
- ClinicalTrials.gov ID
- NCT00604370
- Acronym / sponsor ID
- 2006-P-001981
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Jan 2008 (estimated)
- 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.
An investigator initiated study exploring VTE prophylaxis at the time of hospital discharge.
Detailed description
It appears likely that many patients will remain at risk for VTE at the time of hospital discharge. These risks will go unrecognized, and discharge prophylaxis orders will not be prescribed.
To test this hypothesis, we will perform a retrospective review of approximately 2,500 patients at Brigham and Women's Hospital at risk for VTE at the time of hospital discharge to determine what proportion received VTE prophylaxis. We will correlate the implementation of discharge VTE prophylaxis with the occurrence of symptomatic DVT and pulmonary embolism within 90 days of hospital discharge.
We will also conduct a substudy of this patient population to determine adherence to VTE prophylaxis among hospitalized patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Acutely ill medical and surgical patients who were hospitalized at BWH, and at-risk for VTE, but were not treated with prophylaxis at hospital discharge. |
| 2 | – | –Acutely ill medical and surgical patients who were at risk for VTE at time of hospital discharge and prescribed a prophylaxis strategy. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acutely ill medical and surgical patients who were hospitalized at BWH and who are at risk for DVT.
Key inclusion criteria (1 listed)
- Acutely ill medical and surgical patients with a risk score of 4 or greater without prophylaxis or a risk score of 4 or greater with anticoagulation at hospital discharge.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptomatic PE/DVT within 90 days of hospital discharge.
Time frame: 90 days
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 10 Feb 2012.
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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.
Samuel Z Goldhaber, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Brigham and Women's Hospital.
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 1 inclusion and 1 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 10 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Symptomatic PE/DVT within 90 days of hospital discharge. (time frame: 90 days). 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 10 Feb 2012.