Deep Vein Thrombosis (DVT)Phase 4NCT03805672
Below Knee DVT Study
A Phase 4 study testing Low Dose Enoxaparin and High Dose Enoxaparin in people with Deep Vein Thrombosis (DVT) and Blood Clots, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Hospitalized patients are at risk of developing blood clots in the legs (Deep Vein Thrombosis or DVT), which can lead to death if those clots break off and migrate to the lungs. We know that if there is a blood clot in the large leg veins near the hips and in the thighs, treating these patients with high-doses of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis (DVT), Blood Clots
- What is being tested?
- Low Dose Enoxaparin and High Dose Enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jul 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients over the age of 18 admitted to a trauma or general surgery service will be eligible
- Patients diagnosed with an isolated distal DVT
- Able to obtain informed consent
Who cannot join
- Patients with a previous diagnosis of hypercoagulability
- Patients on chronic anticoagulation
- Patients with a history of heparin induced thrombocytopenia
- Patients have preexisting contraindications to anticoagulation
- Patients in renal failure requiring adjusted enoxaparin dosing
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97206
About this study
Official title: Is Therapeutic Anticoagulation Necessary for the Treatment of Distal Deep Venous Thrombosis of the Lower Extremity? A Randomized, Controlled Trial
Hospitalized patients are at risk of developing blood clots in the legs (Deep Vein Thrombosis or DVT), which can lead to death if those clots break off and migrate to the lungs. We know that if there is a blood clot in the large leg veins near the hips and in the thighs, treating these patients with high-doses of blood thinners reduces the risk of these deaths.
It is unclear if treating blood clots in the calf with high doses of blood thinners is better than using low doses. In this study, after being diagnosed with a blood clot in the calf, patients will be treated with either low dose or high dose enoxaparin (Lovenox), a blood thinner. We will then see if low dose blood thinner has similar results as high dose blood thinner.
- Conditions
- Deep Vein Thrombosis (DVT), Blood Clots
- Being tested
- Low Dose Enoxaparin, High Dose Enoxaparin
- Keywords
- Lovenox, enoxaparin, DVT
- Medical subject headings
- Venous Thrombosis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose EnoxaparinDrug
Also called Lovenox
High Dose EnoxaparinDrug
Also called Lovenox
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Enoxaparin | Active comparator | Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution. Receives: Drug: Low Dose Enoxaparin |
| High Dose Enoxaparin | Active comparator | Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution. Receives: Drug: High Dose Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep Vein Thrombosis Resolution
Evaluation of DVT resolution
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study startSep 2014
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Terminated due to low enrollment because of decrease in DVT rates.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Deep Vein Thrombosis (DVT)Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin A Schreiber, MD, Oregon Health and Science University
- Investigators
- Martin Schreiber, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805672
- Sponsor's protocol ID
- 9134
- Status last verified
- Feb 2019
- First submitted
- 14 Jan 2015
- Last updated
- 13 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Therapeutic Anticoagulation Necessary for the Treatment of Distal Deep Venous Thrombosis of the Lower Extremity? A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03805672
- Acronym / sponsor ID
- 9134
- Conditions
- Deep Vein Thrombosis (DVT), Blood Clots
- Keywords
- Lovenox, enoxaparin, DVT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low enrollment because of decrease in DVT rates.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Posted 13 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hospitalized patients are at risk of developing blood clots in the legs (Deep Vein Thrombosis or DVT), which can lead to death if those clots break off and migrate to the lungs. We know that if there is a blood clot in the large leg veins near the hips and in the thighs, treating these patients with high-doses of blood thinners reduces the risk of these deaths.
It is unclear if treating blood clots in the calf with high doses of blood thinners is better than using low doses. In this study, after being diagnosed with a blood clot in the calf, patients will be treated with either low dose or high dose enoxaparin (Lovenox), a blood thinner. We will then see if low dose blood thinner has similar results as high dose blood thinner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Enoxaparin | Active comparator | Drug: Low Dose EnoxaparinSubjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution. |
| High Dose Enoxaparin | Active comparator | Drug: High Dose EnoxaparinSubjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over the age of 18 admitted to a trauma or general surgery service will be eligible
- Patients diagnosed with an isolated distal DVT
- Able to obtain informed consent
Key exclusion criteria (6 listed)
- Patients with a previous diagnosis of hypercoagulability
- Patients on chronic anticoagulation
- Patients with a history of heparin induced thrombocytopenia
- Patients have preexisting contraindications to anticoagulation
- Patients in renal failure requiring adjusted enoxaparin dosing
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 |
|---|---|---|
| Low Dose EnoxaparinAlso: Lovenox | Drug | Low Dose Enoxaparin |
| High Dose EnoxaparinAlso: Lovenox | Drug | High Dose Enoxaparin |
Primary outcome
Deep Vein Thrombosis Resolution
Time frame: 6 weeks
Evaluation of DVT resolution
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
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SAFELY RULING OUT DEEP VEIN THROMBOSIS IN PREGNANCY WITH THE LEFt SCORE AND TRIMESTER-ADJUSTED D-DIMER CUTOFFS (the PREG-DVT Study): A PROSPECTIVE COHORT STUDY.
Pregnancy Related, Deep Vein Thrombosis
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.
Martin Schreiber, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low Dose Enoxaparin and High Dose Enoxaparin in people with Deep Vein Thrombosis (DVT) and Blood Clots, run by Oregon Health and Science University 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 6 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: stopped early, as of the sponsor's last update on 13 Mar 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Deep Vein Thrombosis Resolution (time frame: 6 weeks). 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 13 Mar 2019.