Deep Venous ThrombosisNCT02078154
Measurement of D-Dimer Levels in Patients With Confirmed Deep Vein Thrombosis
An observational study of Deep Venous Thrombosis, run by Diagnostica Stago at 1 site in United States.
Trial summary
Measurement of D-Di (D-Dimer) levels using the in-vitro diagnostic reagent STA® - Liatest® D-Di and STA® - Liatest® D-Di PLUS in plasma samples from patients diagnosed with Deep Vein Thrombosis (DVT) Data from this study may be used in conjunction with data from the prospective study entitled "STA® - Liatest® D-Di … Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Deep Venous Thrombosis
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jan 2015
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with proximal DVT diagnosed by imaging technique and with a low and moderate Wells score
Who may be able to join
- The study population tested will be recruited from ambulatory outpatients (presenting at the emergency unit or outpatient clinic) suspected of having DVT.
- Patient is < 80 years old.
- Patient presenting at least one of these symptoms indicative of proximal DVT: leg pain, tenderness (discomfort through palpation), leg swelling and /or edema,
- Patient has confirmed proximal DVT by imaging
- Low or moderate Wells score
- Patient provides written informed consent to participate in the sample collection
Who cannot join
- Patient presenting with a condition that may be associated with increased D-dimer levels, even in the absence of VTE, such as:
- Fibrinolytic therapy within the previous seven (7) days,
- Bone fracture or surgery (with general anesthesia longer than thirty (30) minutes) within the previous one (1) month,
- Deep hematoma diagnosed by imaging techniques within the previous one (1) month,
- Disseminated malignancies and active cancer (active cancer defined as: cancer for which therapeutic or palliative treatment is either ongoing at the time of enrolment or has stopped less than six (6) months before enrolment),
- Sepsis, severe infections, pneumonia within the previous 1 month,
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- Known liver cirrhosis,
- Pregnancy or post-partum within the previous 1 month,
- Atherosclerotic vascular disease thrombosis within the previous 1month (e.g. myocardial infarction, stroke, coronary syndrome, peripheral artery disease stage III or IV),
- Sickle cell disease,
- Patients presenting with a suspect thrombotic event related to catheter implantation
- Ongoing therapeutic anticoagulants (curative and preventive treatment) starting twenty four (24) hours or more before the blood drawing for D-dimer testing
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Measurement of D-Di (D-Dimer) levels using the in-vitro diagnostic reagent STA® - Liatest® D-Di and STA® - Liatest® D-Di PLUS in plasma samples from patients diagnosed with Deep Vein Thrombosis (DVT) Data from this study may be used in conjunction with data from the prospective study entitled "STA® - Liatest® D-Di - Exclusion of Venous Thromboembolism (VTE)", NCT01221805, the DiET study,
- Conditions
- Deep Venous Thrombosis
- Keywords
- D-Dimer, DVT, Wells score
- Medical subject headings
- Venous Thrombosis
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 |
|---|---|---|
| Deep Venous Thrombosis (DVT) | DVT diagnosed by imaging technique with a low or moderate Wells score |
What is being measured
The primary outcome is the main question the study is designed to answer.
STA Liatest DDi results in DVT positive cases
Prospective, ambulatory outpatients (presenting to the emergency unit or outpatient clinic) suspected of having DVT, with a proximal positive imaging results, will be screened for eligibility using the inclusion and exclusion criteria (see Section above). Then the eligible patients will be evaluated using the Wells score and only patient with Low or moderate Pre-Test Probability (PTP) will receive full explanation concerning nature, objectives and risks associated to the participation in this study. Written informed consent will be obtained from each participating subject prior blood drawing, processing, plasma aliquoting and freezing at -80°C for D-Dimer testing (STA Liatest DDi). The whole process, starting from the moment the patient is diagnosed with DVT, should not exceed 24 hours.
Measured: At the initial visit (up to 24 hours)
Secondary outcomes (1)
STA Liatest DDi Versus STA Liatest DDi Plus
Prospective, ambulatory outpatients (presenting to the emergency unit or outpatient clinic) suspected of having DVT, with a proximal positive imaging results, will be screened for eligibility using the inclusion and exclusion criteria (see Section above). Then the eligible patients will be evaluated using the Wells score and only patient with Low or moderate PTP will receive full explanation concerning nature, objectives and risks associated to the participation in this study. Written informed consent will be obtained from each participating subject prior blood drawing, processing, plasma aliquoting and freezing at -80°C for D-Dimer testing (STA Liatest DDi Plus). The whole process, starting from the moment the patient is diagnosed with DVT, should not exceed 24 hours
Measured: At the initial visit (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Decision to start a new study on DVT with another protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ThrombosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diagnostica Stago
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suman Wasan Rathbun, MD, Principal investigator, University of Oklahoma Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078154
- Sponsor's protocol ID
- D-Dimer DVT
- Status last verified
- Jun 2015
- First submitted
- 26 Feb 2014
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of D-Dimer Levels in Patients With Confirmed Deep Vein Thrombosis
- ClinicalTrials.gov ID
- NCT02078154
- Acronym / sponsor ID
- D-Dimer DVT
- Conditions
- Deep Venous Thrombosis
- Keywords
- D-Dimer, DVT, Wells score
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decision to start a new study on DVT with another protocol
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Diagnostica StagoIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 5 Mar 2014 (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.
Measurement of D-Di (D-Dimer) levels using the in-vitro diagnostic reagent STA® - Liatest® D-Di and STA® - Liatest® D-Di PLUS in plasma samples from patients diagnosed with Deep Vein Thrombosis (DVT) Data from this study may be used in conjunction with data from the prospective study entitled "STA® - Liatest® D-Di - Exclusion of Venous Thromboembolism (VTE)", NCT01221805, the DiET study,
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Venous Thrombosis (DVT) | – | –DVT diagnosed by imaging technique with a low or moderate Wells score |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with proximal DVT diagnosed by imaging technique and with a low and moderate Wells score
Key inclusion criteria (6 listed)
- The study population tested will be recruited from ambulatory outpatients (presenting at the emergency unit or outpatient clinic) suspected of having DVT.
- Patient is < 80 years old.
- Patient presenting at least one of these symptoms indicative of proximal DVT: leg pain, tenderness (discomfort through palpation), leg swelling and /or edema,
- Patient has confirmed proximal DVT by imaging
- Low or moderate Wells score
Key exclusion criteria (12 listed)
- Patient presenting with a condition that may be associated with increased D-dimer levels, even in the absence of VTE, such as:
- Patients presenting with a suspect thrombotic event related to catheter implantation
- Ongoing therapeutic anticoagulants (curative and preventive treatment) starting twenty four (24) hours or more before the blood drawing for D-dimer testing
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
STA Liatest DDi results in DVT positive cases
Time frame: At the initial visit (up to 24 hours)
Prospective, ambulatory outpatients (presenting to the emergency unit or outpatient clinic) suspected of having DVT, with a proximal positive imaging results, will be screened for eligibility using the inclusion and exclusion criteria (see Section above). Then the eligible patients will be evaluated using the Wells score and only patient with Low or moderate Pre-Test Probability (PTP) will receive full explanation concerning nature, objectives and risks associated to the participation in this study. Written informed consent will be obtained from each participating subject prior blood drawing, processing, plasma aliquoting and freezing at -80°C for D-Dimer testing (STA Liatest DDi). The whole process, starting from the moment the patient is diagnosed with DVT, should not exceed 24 hours.
1 secondary outcome
STA Liatest DDi Versus STA Liatest DDi Plus
Time frame: At the initial visit (up to 24 hours)
Results and safety
The study was stopped early (reason given: Decision to start a new study on DVT with another protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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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.
Suman Wasan Rathbun, MD principal investigator
University of Oklahoma Health Sciences
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 Deep Venous Thrombosis, run by Diagnostica Stago 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 6 inclusion and 12 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 3 Jun 2015. 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 was stopped early (reason given: Decision to start a new study on DVT with another protocol). 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?
STA Liatest DDi results in DVT positive cases (time frame: At the initial visit (up to 24 hours)). 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 3 Jun 2015.