Venous ThromboembolismSToPNCT02978950
SToP: Venous Thromboembolism Screening in the Trauma Population
A study testing Duplex ultrasound surveillance and No ultrasound surveillance in people with Venous Thromboembolism and Deep Vein Thrombosis, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
This is a prospective, randomized vanguard trial of trauma patients admitted to the trauma surgery service at Intermountain Medical Center who are deemed to be at high risk for venous thromboembolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Deep Vein Thrombosis, Trauma, Multiple
- What is being tested?
- Duplex ultrasound surveillance and No ultrasound surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2017to Jun 2020
- Phase
- Interventional
- 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
Who may be able to join
- Inpatient status on Intermountain Medical Center (IMC) trauma surgery service, admitted within 24 hours of injury.
- Age ≥18 at the time of injury
- Meets the definition of high-risk for VTE according to current IMC trauma service guidelines
Who cannot join
- Patient age <18 years at the time of admission to the hospital
- Pregnancy
- Prisoners
- Patients with a life expectancy of less than 30 days
- Patients with a known hypercoagulable state including:
- Factor V Leiden
Show all 14Show fewer
- Protein C and S deficiencies
- Dysfibrogenemia of any sort
- Active cancer
- Antiphospholipid antibody syndrome
- History of DVT or PE within past 6 months
- Myeloproliferative disorders
- Patients on therapeutic anticoagulation who do not have their agent held upon admission to the hospital.
- Patient elects to opt-out of the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Intermountain Medical Center
Murray, Utah, 84157
Valerie Aston, MBA, RT, 801-507-4606, Valerie.Aston@imail.org
Brent Armbruster, 801-507-4605, Brent.Armbruster@imail.org
About this study
This is a prospective, randomized vanguard trial of trauma patients admitted to the trauma surgery service at Intermountain Medical Center who are deemed to be at high risk for venous thromboembolism. Once identified and enrolled, subjects will be randomized to receive bilateral lower extremity duplex ultrasound surveillance versus no surveillance. The study will compare the two groups with regard to deep vein thrombosis, pulmonary embolism, and major and clinically relevant bleeding episode rates, both during the index hospitalization and at 90 days post-discharge.
- Being tested
- Duplex ultrasound surveillance, No ultrasound surveillance
- Keywords
- duplex ultrasound, trauma, venous thromboembolism, prevention
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Multiple Trauma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duplex ultrasound surveillanceOther
bilateral lower extremity venous duplex
No ultrasound surveillanceOther
will have daily exam and history as per normal clinical routine
| Study group | Role | What they receive |
|---|---|---|
| Surveillance arm | Experimental | Bilateral duplex ultrasound surveillance Receives: Other: Duplex ultrasound surveillance |
| No surveillance arm | Active comparator | no duplex ultrasound surveillance Receives: Other: No ultrasound surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymptomatic lower extremity DVT
any DVT found in the lower extremity
Measured: during index hospitalization, up to 2 weeks
Secondary outcomes (6)
Symptomatic DVT propagation from calf veins to proximal veins
calf vein clot that moves to popliteal vein or higher
Measured: 14 days from hospital discharge
Symptomatic/fatal pulmonary embolism
any pulmonary embolism diagnosed by computed tomography angiogram
Measured: 90 days from hospital discharge
Major and clinically relevant bleeding episodes
as defined by the International Society of Thrombosis and Hemostasis
Measured: during index hospitalization, up to 2 weeks
Composite outcome of proximal DVT plus major and clinically relevant bleeding episodes
additive outcome of above knee thrombosis plus major and clinically relevant bleeding
Measured: during index hospitalization, up to 2 weeks
All cause mortality
Measured: 90 days
Symptomatic DVT
any lower extremity thrombosis that causes clinical symptoms
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 posted1 Dec 2016 (estimated)
- Study start20 Mar 2017
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
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.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Majercik, MD,MBA, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978950
- Sponsor's protocol ID
- 1050048
- Acronym
- SToP
- Status last verified
- Nov 2018
- First submitted
- 23 Nov 2016
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kay AB, Morris DS, Woller SC, Stevens SM, Bledsoe JR, Lloyd JF, Collingridge DS, Majercik S. Trauma patients at risk for venous thromboembolism who undergo routine duplex ultrasound screening experience fewer pulmonary emboli: A prospective randomized trial. J Trauma Acute Care Surg. 2021 May 1;90(5):787-796. doi: 10.1097/TA.0000000000003104.
PubMed 33560104
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SToP: Venous Thromboembolism Screening in the Trauma Population
- ClinicalTrials.gov ID
- NCT02978950
- Acronym / sponsor ID
- SToP / 1050048
- Keywords
- duplex ultrasound, trauma, venous thromboembolism, prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 1 Dec 2016 (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.
This is a prospective, randomized vanguard trial of trauma patients admitted to the trauma surgery service at Intermountain Medical Center who are deemed to be at high risk for venous thromboembolism. Once identified and enrolled, subjects will be randomized to receive bilateral lower extremity duplex ultrasound surveillance versus no surveillance. The study will compare the two groups with regard to deep vein thrombosis, pulmonary embolism, and major and clinically relevant bleeding episode rates, both during the index hospitalization and at 90 days post-discharge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surveillance arm | Experimental | Other: Duplex ultrasound surveillanceBilateral duplex ultrasound surveillance |
| No surveillance arm | Active comparator | Other: No ultrasound surveillanceno duplex ultrasound surveillance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inpatient status on Intermountain Medical Center (IMC) trauma surgery service, admitted within 24 hours of injury.
- Age ≥18 at the time of injury
- Meets the definition of high-risk for VTE according to current IMC trauma service guidelines
Key exclusion criteria (14 listed)
- Patient age <18 years at the time of admission to the hospital
- Pregnancy
- Prisoners
- Patients with a life expectancy of less than 30 days
- Patients with a known hypercoagulable state including:
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 |
|---|---|---|
| Duplex ultrasound surveillancebilateral lower extremity venous duplex | Other | Surveillance arm |
| No ultrasound surveillancewill have daily exam and history as per normal clinical routine | Other | No surveillance arm |
Primary outcome
Asymptomatic lower extremity DVT
Time frame: during index hospitalization, up to 2 weeks
any DVT found in the lower extremity
6 secondary outcomes
Symptomatic DVT propagation from calf veins to proximal veins
Time frame: 14 days from hospital discharge
Symptomatic/fatal pulmonary embolism
Time frame: 90 days from hospital discharge
Major and clinically relevant bleeding episodes
Time frame: during index hospitalization, up to 2 weeks
Composite outcome of proximal DVT plus major and clinically relevant bleeding episodes
Time frame: during index hospitalization, up to 2 weeks
All cause mortality
Time frame: 90 days
Symptomatic DVT
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Derived from this study: PubMed 33560104Kay AB, Morris DS, Woller SC, Stevens SM, Bledsoe JR, Lloyd JF, Collingridge DS, Majercik S. Trauma patients at risk for venous thromboembolism who undergo routine duplex ultrasound screening experience fewer pulmonary emboli: A prospective randomized trial. J Trauma Acute Care Surg. 2021 May 1;90(5):787-796. doi: 10.1097/TA.0000000000003104.
- Individual participant dataSharing planned: No
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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.
Sarah Majercik, MD,MBA principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duplex ultrasound surveillance and No ultrasound surveillance in people with Venous Thromboembolism and Deep Vein Thrombosis, run by Intermountain Health Care, Inc. 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 14 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 29 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brent Armbruster (801-507-4605, brent.armbruster@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asymptomatic lower extremity DVT (time frame: during index hospitalization, up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02978950, 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 29 Nov 2018.