ThromboembolismNCT03073915
Evaluation of the Risk of VTE Among Patients Hospitalized in Non-surgical Departments
An observational study of Thromboembolism, run by Hadassah Medical Organization.
Trial summary
Patients hospitalized in internal wards are at risk for VTE. The current guidelines recommend the use of thromboprophylaxis for 7-10 days among patients who are at increased risk for VTE. Yet several retrospective studies have shown that the compliance with this guideline is low. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thromboembolism
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Dec 2020
- How long will I take part?
- 4 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to the medical wards at the Hadassah University Hospital
Who may be able to join
- Patients admitted to the medical wards at the Hadassah University Hospital
Who cannot join
- None
About this study
Official title: The Risk for VTE Among Patients in the Medical Wards - Prospective Observational Study.
Patients hospitalized in internal wards are at risk for VTE. The current guidelines recommend the use of thromboprophylaxis for 7-10 days among patients who are at increased risk for VTE. Yet several retrospective studies have shown that the compliance with this guideline is low. Physicians are often reluctant to administer LMWH to their fragile patients mainly because they are not convince that the risk associated with such therapy is greater than the risk for VTE.
In the current study, data concerning the use of thromboprophylaxis among patients admitted to the medical wards will be collected. The occurrence of bleeding or thrombotic event will be evaluated prospectively.
Read the detailed description
Data concerning the use of LMWH among patients admitted to the medical wards at the Hadassah University Hospital will be collected prospectively from the electronic medical records. The occurrence of bleeding episodes or thrombotic events will be followed for the next 90 days following discharge from the hospital.
The percent of patients actually treated by LMWH among patients entitled for such therapy according to the most updated international guidelines will be evaluated. The risk of minor and major bleeding will be compared among those given thromboprophylaxis and those who were not treated. Similar comparison will be made for thrombotic events.
- Conditions
- Thromboembolism
- Medical subject headings
- Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombosis
Rate of thrombotic events within 90 days following discharge
Measured: 90 days
Bleeding
Rate of minor and major bleeding episodes within 90 days following discharge
Measured: 90 days
Compliance
Rate of compliance with ACCP guidelines concerning thromboprophylaxis of non-surgical patients.
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 posted8 Mar 2017
- Study startAug 2013
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073915
- Sponsor's protocol ID
- 0090-08-HMO
- Status last verified
- Mar 2018
- First submitted
- 3 Mar 2017
- Last updated
- 12 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk for VTE Among Patients in the Medical Wards - Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT03073915
- Acronym / sponsor ID
- 0090-08-HMO
- Conditions
- Thromboembolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 8 Mar 2017 (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.
Patients hospitalized in internal wards are at risk for VTE. The current guidelines recommend the use of thromboprophylaxis for 7-10 days among patients who are at increased risk for VTE. Yet several retrospective studies have shown that the compliance with this guideline is low. Physicians are often reluctant to administer LMWH to their fragile patients mainly because they are not convince that the risk associated with such therapy is greater than the risk for VTE.
In the current study, data concerning the use of thromboprophylaxis among patients admitted to the medical wards will be collected. The occurrence of bleeding or thrombotic event will be evaluated prospectively.
Detailed description
Data concerning the use of LMWH among patients admitted to the medical wards at the Hadassah University Hospital will be collected prospectively from the electronic medical records. The occurrence of bleeding episodes or thrombotic events will be followed for the next 90 days following discharge from the hospital.
The percent of patients actually treated by LMWH among patients entitled for such therapy according to the most updated international guidelines will be evaluated. The risk of minor and major bleeding will be compared among those given thromboprophylaxis and those who were not treated. Similar comparison will be made for thrombotic events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to the medical wards at the Hadassah University Hospital
Key inclusion criteria (1 listed)
- Patients admitted to the medical wards at the Hadassah University Hospital
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
Thrombosis
Time frame: 90 days
Rate of thrombotic events within 90 days following discharge
Bleeding
Time frame: 90 days
Rate of minor and major bleeding episodes within 90 days following discharge
Compliance
Time frame: 90 days
Rate of compliance with ACCP guidelines concerning thromboprophylaxis of non-surgical patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolism, run by Hadassah Medical Organization.
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: status not confirmed, as of the sponsor's last update on 12 Jun 2018. 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?
Results are not available in the source record.
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?
Thrombosis (time frame: 90 days). The study lists 3 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 12 Jun 2018.