TraumaPhase 4NCT02342444
Lovenox 30 mg Twice Daily (BID) Versus 40 mg Once Daily (QD)
A Phase 4 study testing Enoxaparin Sodium Injection 30 mg BID and Enoxaparin Sodium Injection 40 mg QD in people with Trauma and Surgery, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many times enoxaparin (or Lovenox) is given to patients who are at a higher risk of developing clots in their legs or lungs. There are two standard doses of enoxaparin that are recommended by the drug companies. Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Trauma, Surgery, Deep Vein Thrombosis (DVT)
- What is being tested?
- Enoxaparin Sodium Injection 30 mg BID and Enoxaparin Sodium Injection 40 mg QD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 31 Mar 2025
- Phase
- Phase 4
- 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 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admitted patients requiring prophylactic dosing of enoxaparin (Lovenox)
- Admitted to the trauma or surgical service
- Age greater than 15 years
Who cannot join
- Unable to obtain consent from patient or authorized representative
- Presence of intracranial hemorrhage
- Receiving therapeutic dose of enoxaparin (Lovenox)
- Receiving other forms of anticoagulation
- Presence of renal failure requiring non-standard dosing regimen
Trial locations and contacts
1 site in 1 country.
Laura Nguyen contact
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Laura Nguyen, nguyelau@ohsu.edu
About this study
Official title: A Prospective Randomized Trial Comparing Two Standard Doses of Enoxaparin for the Prevention of Thromboembolism in Surgical Patients
The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many times enoxaparin (or Lovenox) is given to patients who are at a higher risk of developing clots in their legs or lungs. There are two standard doses of enoxaparin that are recommended by the drug companies. These two doses have never been directly compared in trauma, general, and vascular surgery patients. The purposes of this study are:
- to compare the development of blood clots in patients receiving 30mg twice daily of enoxaparin compared to patients receiving 40mg once daily of enoxaparin.
- to determine if there is higher risk of bleeding complications in patients receiving 30mg twice daily of enoxaparin compared to patients receiving 40mg once daily.
Read more
Patients enrolled into the study will be randomized to receive enoxaparin, 30mg twice daily or enoxaparin, 40mg once daily. Patients will then be monitored for signs and symptoms of blood clots. At the time of discharge (or before, if medically indicated), an ultrasound test will be performed to look for blood clots in the patient's legs.
The investigators will compare incidence of blood clots formed between the 2 groups of patients to determine if one dose of enoxaparin relates to a lower rate of blood clots in critically ill patients. The investigators will also compare the incidence of bleeding complications between the 2 groups.
Read the detailed description
This is a prospective randomized single center study in human subjects.
Initiation of enoxaparin thromboprophylaxis will be done by the treatment team. Patients admitted to the trauma service will be eligible for enrollment. Research staff will approach patients or their LARs for consent prior to or at the time enoxaparin is ordered. This will include patients with traumatic intracranial hemorrhage, after the consulting neurosurgical team and primary treatment team decide to initiate thromboprophylaxis. Once enrolled, the subject will be randomized to receive either 30 mg twice daily dosing or 40 mg daily dosing of enoxaparin. However, treatment team will be responsible for deciding when to start enoxaparin treatment. Patients who are discharged without receiving enoxaparin or are started on a non-standard or therapeutic dose will be withdrawn from the study. Patient characteristics: age, sex, body mass index (BMI), medical comorbidities, Acute Physiology and Chronic Health Evaluation II score (APACHE II), injuries, and operations will be collected, coded with a unique identification letter and number combination, and entered into a database.
All patients will undergo weekly ultrasound duplex examination of the lower extremities for the presence of deep venous thrombosis. Patients who develop symptoms of pulmonary embolism including acute shortness of breath and increased A-a gradient will undergo computed tomography angiography as part of their standard care. A bleeding complication will be defined as a known bleeding episode associated with hypotension (greater than 20 mmHG drop from baseline) and the need for blood transfusion.
Current practice at OHSU is for patients age 15 and above to be admitted to the adult trauma service, and are treated with the same standard of care as adults. Currently, there are no clear data stratifying the risk of VTE in this population compared to other age groups. Therefore, patients in this age range on the adult Trauma Service will be included in the study as they are treated in the same method as our adult patient population.
- Conditions
- Trauma, Surgery, Deep Vein Thrombosis (DVT), Thromboembolic Events
- Being tested
- Enoxaparin Sodium Injection 30 mg BID, Enoxaparin Sodium Injection 40 mg QD
- Keywords
- Trauma, Surgery, Enoxaparin, DVTs, Thromboembolic events
- Medical subject headings
- Wounds and Injuries, Venous Thrombosis, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin Sodium Injection 30 mg BIDDrug
Also called Lovenox
Enoxaparin Sodium Injection 40 mg QDDrug
Also called Lovenox
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin Sodium Injection 30 mg BID | Active comparator | Subjects are randomized to receive 30 mg twice daily of enoxaparin. Receives: Drug: Enoxaparin Sodium Injection 30 mg BID |
| Enoxaparin Sodium Injection 40 mg QD | Active comparator | Subjects are randomized to receive 40 mg once daily of enoxaparin. Receives: Drug: Enoxaparin Sodium Injection 40 mg QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboembolic events
Daily monitoring per standard of care for the development of thromboembolic events.
Measured: Daily, up to Day 90
Secondary outcomes (1)
Increase in bleeding complications
Daily monitoring for an increase in bleeding complications due to study drug dose and regime.
Measured: Daily, up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startFeb 2014
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- 606 participants (estimated)
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 A Schreiber, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342444
- Sponsor's protocol ID
- 8080
- Status last verified
- Apr 2024
- First submitted
- 21 May 2014
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Two Standard Doses of Enoxaparin for the Prevention of Thromboembolism in Surgical Patients
- ClinicalTrials.gov ID
- NCT02342444
- Acronym / sponsor ID
- 8080
- Conditions
- Trauma, Surgery, Deep Vein Thrombosis (DVT), Thromboembolic Events
- Keywords
- Trauma, Surgery, Enoxaparin, DVTs, Thromboembolic events
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 606 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 21 Jan 2015 (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.
The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many times enoxaparin (or Lovenox) is given to patients who are at a higher risk of developing clots in their legs or lungs. There are two standard doses of enoxaparin that are recommended by the drug companies. These two doses have never been directly compared in trauma, general, and vascular surgery patients. The purposes of this study are:
- to compare the development of blood clots in patients receiving 30mg twice daily of enoxaparin compared to patients receiving 40mg once daily of enoxaparin.
- to determine if there is higher risk of bleeding complications in patients receiving 30mg twice daily of enoxaparin compared to patients receiving 40mg once daily.
Patients enrolled into the study will be randomized to receive enoxaparin, 30mg twice daily or enoxaparin, 40mg once daily. Patients will then be monitored for signs and symptoms of blood clots. At the time of discharge (or before, if medically indicated), an ultrasound test will be performed to look for blood clots in the patient's legs.
The investigators will compare incidence of blood clots formed between the 2 groups of patients to determine if one dose of enoxaparin relates to a lower rate of blood clots in critically ill patients. The investigators will also compare the incidence of bleeding complications between the 2 groups.
Detailed description
This is a prospective randomized single center study in human subjects.
Initiation of enoxaparin thromboprophylaxis will be done by the treatment team. Patients admitted to the trauma service will be eligible for enrollment. Research staff will approach patients or their LARs for consent prior to or at the time enoxaparin is ordered. This will include patients with traumatic intracranial hemorrhage, after the consulting neurosurgical team and primary treatment team decide to initiate thromboprophylaxis. Once enrolled, the subject will be randomized to receive either 30 mg twice daily dosing or 40 mg daily dosing of enoxaparin. However, treatment team will be responsible for deciding when to start enoxaparin treatment. Patients who are discharged without receiving enoxaparin or are started on a non-standard or therapeutic dose will be withdrawn from the study. Patient characteristics: age, sex, body mass index (BMI), medical comorbidities, Acute Physiology and Chronic Health Evaluation II score (APACHE II), injuries, and operations will be collected, coded with a unique identification letter and number combination, and entered into a database.
All patients will undergo weekly ultrasound duplex examination of the lower extremities for the presence of deep venous thrombosis. Patients who develop symptoms of pulmonary embolism including acute shortness of breath and increased A-a gradient will undergo computed tomography angiography as part of their standard care. A bleeding complication will be defined as a known bleeding episode associated with hypotension (greater than 20 mmHG drop from baseline) and the need for blood transfusion.
Current practice at OHSU is for patients age 15 and above to be admitted to the adult trauma service, and are treated with the same standard of care as adults. Currently, there are no clear data stratifying the risk of VTE in this population compared to other age groups. Therefore, patients in this age range on the adult Trauma Service will be included in the study as they are treated in the same method as our adult patient population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin Sodium Injection 30 mg BID | Active comparator | Drug: Enoxaparin Sodium Injection 30 mg BIDSubjects are randomized to receive 30 mg twice daily of enoxaparin. |
| Enoxaparin Sodium Injection 40 mg QD | Active comparator | Drug: Enoxaparin Sodium Injection 40 mg QDSubjects are randomized to receive 40 mg once daily of enoxaparin. |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted patients requiring prophylactic dosing of enoxaparin (Lovenox)
- Admitted to the trauma or surgical service
- Age greater than 15 years
Key exclusion criteria (5 listed)
- Unable to obtain consent from patient or authorized representative
- Presence of intracranial hemorrhage
- Receiving therapeutic dose of enoxaparin (Lovenox)
- Receiving other forms of anticoagulation
- Presence of renal failure requiring non-standard dosing regimen
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 |
|---|---|---|
| Enoxaparin Sodium Injection 30 mg BIDAlso: Lovenox | Drug | Enoxaparin Sodium Injection 30 mg BID |
| Enoxaparin Sodium Injection 40 mg QDAlso: Lovenox | Drug | Enoxaparin Sodium Injection 40 mg QD |
Primary outcome
Thromboembolic events
Time frame: Daily, up to Day 90
Daily monitoring per standard of care for the development of thromboembolic events.
1 secondary outcome
Increase in bleeding complications
Time frame: Daily, up to Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
Related trials for Trauma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
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.
Laura Nguyen contact
Martin A 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 Enoxaparin Sodium Injection 30 mg BID and Enoxaparin Sodium Injection 40 mg QD in people with Trauma and Surgery, 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 5 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 3 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Nguyen (nguyelau@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thromboembolic events (time frame: Daily, up to Day 90). 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 Apr 2024.