Venous ThromboembolismNCT00810784
Evaluation of Venous Thromboembolism (VTE) Prophylaxis in Medically Ill Patients
An observational study of Venous Thromboembolism, run by University of Utah at 1 site in United States.
Trial summary
VTE prophylaxis is not as routinely employed in medically ill patients as compared to surgical patients. This retrospective chart review project will evaluate the effectiveness of VTE prophylaxis in medically ill patients at the University of Utah Hospitals and Clinics compared to current literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Mar 2007
- 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: Data was collected on consecutive patients ≥18 years with a hospital length of stay of >48 hours admitted to the cardiology, pulmonary, or general medical services. Admission dates were a sample of two different two-week blocks (January 1-14, 2006 and April 1-14, 2006). These blocks were chosen to be consistent with dates of analysis in the pre-intervention cohort. Patients receiving therapeutic anticoagulation were excluded.
Who may be able to join
- Hospitalized at the University of Utah on one our medical services.
Who cannot join
- Patients received therapeutic anticoagulation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
About this study
VTE prophylaxis is not as routinely employed in medically ill patients as compared to surgical patients. This retrospective chart review project will evaluate the effectiveness of VTE prophylaxis in medically ill patients at the University of Utah Hospitals and Clinics compared to current literature. The study will ultimately serve as a quality improvement project to help improve patient care.
- Conditions
- Venous Thromboembolism
- Being tested
- Education
- Keywords
- Venous Thromboembolism, Prevention, Quality Improvement, Education, Compliance with VTE prophylaxis
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
(1) a risk-assessment tool completed at the time of a hospital admission, (2) structured educational sessions on VTE prevention, and (3) audit-feedback where institutional data was reviewed during the educational sessions. These sessions were given once to the clinical pharmacists and on three separate occasions to the medicine house officers.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients cared for before our intervention. | |
| 2 | Patients cared for after our intervention. Receives: Behavioral: Education |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startMar 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Matthew Rondina, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810784
- Sponsor's protocol ID
- UUHSC-IRB-00018164
- Status last verified
- Dec 2008
- First submitted
- 16 Dec 2008
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stinnett JM, Pendleton R, Skordos L, Wheeler M, Rodgers GM. Venous thromboembolism prophylaxis in medically ill patients and the development of strategies to improve prophylaxis rates. Am J Hematol. 2005 Mar;78(3):167-72. doi: 10.1002/ajh.20281.
PubMed 15726600
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Venous Thromboembolism (VTE) Prophylaxis in Medically Ill Patients
- ClinicalTrials.gov ID
- NCT00810784
- Acronym / sponsor ID
- UUHSC-IRB-00018164
- Conditions
- Venous Thromboembolism
- Keywords
- Venous Thromboembolism, Prevention, Quality Improvement, Education, Compliance with VTE prophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 18 Dec 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.
VTE prophylaxis is not as routinely employed in medically ill patients as compared to surgical patients. This retrospective chart review project will evaluate the effectiveness of VTE prophylaxis in medically ill patients at the University of Utah Hospitals and Clinics compared to current literature. The study will ultimately serve as a quality improvement project to help improve patient care.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients cared for before our intervention. |
| 2 | – | Behavioral: EducationPatients cared for after our intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data was collected on consecutive patients ≥18 years with a hospital length of stay of >48 hours admitted to the cardiology, pulmonary, or general medical services. Admission dates were a sample of two different two-week blocks (January 1-14, 2006 and April 1-14, 2006). These blocks were chosen to be consistent with dates of analysis in the pre-intervention cohort. Patients receiving therapeutic anticoagulation were excluded.
Key inclusion criteria (1 listed)
- Hospitalized at the University of Utah on one our medical services.
Key exclusion criteria (1 listed)
- Patients received therapeutic anticoagulation.
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 |
|---|---|---|
| Education(1) a risk-assessment tool completed at the time of a hospital admission, (2) structured educational sessions on VTE prevention, and (3) audit-feedback where institutional data was reviewed during the educational sessions. These sessions were given once to the clinical pharmacists and on three separate occasions to the medicine house officers. | Behavioural | 2 |
Primary outcome
Not reported in the source record.
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 18 Dec 2008.
- Background: PubMed 15726600Stinnett JM, Pendleton R, Skordos L, Wheeler M, Rodgers GM. Venous thromboembolism prophylaxis in medically ill patients and the development of strategies to improve prophylaxis rates. Am J Hematol. 2005 Mar;78(3):167-72. doi: 10.1002/ajh.20281.
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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.
Matthew Rondina, M.D. principal investigator
University of Utah
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 Venous Thromboembolism, run by University of Utah 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 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 18 Dec 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00810784, which also lists 1 linked publication.
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 18 Dec 2008.