Venous ThromboembolismPhase 4NCT02396732

Aspirin and Enoxaparin for VTE in Trauma

A Phase 4 study testing Aspirin and Enoxaparin in people with Venous Thromboembolism and Thromboprophylaxis, run by University of Miami at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Venous Thromboembolism, Thromboprophylaxis, Trauma
What is being tested?: Aspirin and Enoxaparin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: Feb 2016to 15 May 2018
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

Age 18 years or older
Blunt or penetrating trauma
Requires VTE thromboprophylaxis
High-risk for VTE

Who cannot join

Presence of VTE upon admission
Pregnant or nursing
Inability to give informed consent by patient or healthcare proxy
Contraindication to enoxaparin
Contraindication to aspirin
Epidural or subdural hematoma
Presence, or removal within the last 12 hours, of an epidural or spinal catheter, or recent (within the last 12 hours) epidural or spinal anesthesia/procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

Ryder Trauma Center
Miami, Florida, 33136

Other trials in United States

About this study

Official title: The Role Of Combined Therapy With Aspirin and Enoxaparin In Prevention Of Venous Thromboembolism In Trauma Patients: A Randomized-Controlled Trial

The purpose of this study is to determine if the addition of antiplatelet therapy (i.e. aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of venous thromboembolism (VTE) in high-risk critically injured patients. The investigators further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and enoxaparin for decreasing the incidence of VTE after trauma.

Conditions: Venous Thromboembolism, Thromboprophylaxis, Trauma
Being tested: Aspirin, Enoxaparin
Keywords: Aspirin, Enoxaparin, Thromboprophylaxis, Trauma, Venous thromboembolism
Medical subject headings: Venous Thromboembolism, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AspirinDrug
Daily dose is 81 mg oral tablet
EnoxaparinDrug
Daily dose is by subcutaneous injection and weight based at the discretion of the treating clinician.

Study groups in NCT02396732
Study group	Role	What they receive
Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)	Experimental	Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge. Receives: Drug: Aspirin; Drug: Enoxaparin
Low Molecular Weight Heparin (LMWH) Alone	Active comparator	Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge. Receives: Drug: Enoxaparin

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Venous Thromboembolism
Incidence of VTE is defined as new cases reported of: 1. Deep Vein Thrombosis (DVT), symptomatic or asymptomatic as assessed via venous duplex ultrasonography, and 2. Pulmonary Embolism (PE), symptomatic or asymptomatic as assessed via chest computed tomography with angiography (CTA) or ventilation-perfusion (VQ) Scan
Measured: Up to 2 months of hospitalization

Secondary outcomes (2)

Change in Hypercoagulability
Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG)
Measured: Baseline, up to 2 months hospitalization
Mortality
Mortality will be reported as the number of participants with reported death upon hospital discharge
Measured: Up to 2 months of hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201615 May 2018

First posted24 Mar 2015 (estimated)
Study startFeb 2016
Primary completion15 May 2018
Study completion15 May 2018

Why it stopped: Terminated due to futility and less subjects meeting entry criteria

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 Venous ThromboembolismStudies of the same condition, open and under way.
More trials run by University of MiamiThe 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: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02396732
Sponsor's protocol ID: 20140937
Status last verified: Oct 2019
First submitted: 12 Mar 2015
Last updated: 19 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
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Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
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REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
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RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
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All Venous Thromboembolism trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role Of Combined Therapy With Aspirin and Enoxaparin In Prevention Of Venous Thromboembolism In Trauma Patients: A Randomized-Controlled Trial
ClinicalTrials.gov ID: NCT02396732
Acronym / sponsor ID: 20140937
Conditions: Venous Thromboembolism, Thromboprophylaxis, Trauma
Keywords: Aspirin, Enoxaparin, Thromboprophylaxis, Trauma, Venous thromboembolism
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to futility and less subjects meeting entry criteria
Enrolment: 31 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Study start: Feb 2016
Primary completion: 15 May 2018 (actual)
Study completion: 15 May 2018 (actual)
First posted: 24 Mar 2015 (estimated)
Results: Posted 19 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)	Experimental	Drug: Aspirin, Drug: EnoxaparinGroup will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.
Low Molecular Weight Heparin (LMWH) Alone	Active comparator	Drug: EnoxaparinGroup will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 18 years or older
Blunt or penetrating trauma
Requires VTE thromboprophylaxis
High-risk for VTE

Key exclusion criteria (7 listed)

Presence of VTE upon admission
Pregnant or nursing
Inability to give informed consent by patient or healthcare proxy
Contraindication to enoxaparin
Contraindication to aspirin

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
AspirinDaily dose is 81 mg oral tablet	Drug	Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)
EnoxaparinDaily dose is by subcutaneous injection and weight based at the discretion of the treating clinician.	Drug	Low Molecular Weight Heparin (LMWH) + Aspirin (ASA), Low Molecular Weight Heparin (LMWH) Alone

Primary outcome

Incidence of Venous Thromboembolism
Time frame: Up to 2 months of hospitalization
Incidence of VTE is defined as new cases reported of: 1. Deep Vein Thrombosis (DVT), symptomatic or asymptomatic as assessed via venous duplex ultrasonography, and 2. Pulmonary Embolism (PE), symptomatic or asymptomatic as assessed via chest computed tomography with angiography (CTA) or ventilation-perfusion (VQ) Scan

2 secondary outcomes

Change in Hypercoagulability
Time frame: Baseline, up to 2 months hospitalization
Mortality
Time frame: Up to 2 months of hospitalization

Results and safety

Results posted to the registry on 19 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LMWH + ASA	14	14
LMWH Alone	17	17

Primary outcome: Incidence of Venous Thromboembolism

Time frame: Up to 2 months of hospitalization. Number. Unit: incidents

Measure	LMWH + ASA n = 14	LMWH Alone n = 17
Value	1	3

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LMWH + ASA	2 of 14 (14.3%)	1 of 14 (7.1%)	0 of 14
LMWH Alone	4 of 17 (23.5%)	1 of 17 (5.9%)	1 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Venous Thromboembolism

RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
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RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
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RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
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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.

Kenneth Proctor, PhD principal investigator

University of Miami

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 Aspirin and Enoxaparin in people with Venous Thromboembolism and Thromboprophylaxis, run by University of Miami 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 4 inclusion and 7 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 19 Nov 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 19 Nov 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?

Incidence of Venous Thromboembolism (time frame: Up to 2 months of hospitalization). 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 NCT02396732.

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 19 Nov 2019.