Enoxaparin Dosing Regimens for Blood Clots
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two different doses of enoxaparin, a medication used to prevent blood clots, to determine which is more effective and safe for patients in critical care. It compares the development of blood clots and the risk of bleeding in patients receiving either 30mg twice daily or 40mg once daily. Researchers will closely monitor participants for signs of blood clots, and an ultrasound will check for clots in their legs. The trial seeks patients hospitalized for trauma or surgery who need blood clot prevention. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already receiving a therapeutic dose of enoxaparin or other forms of anticoagulation.
What is the safety track record for Enoxaparin Sodium Injection?
Research has shown that enoxaparin, also known as Lovenox, is generally safe for preventing blood clots. The FDA has approved it for several conditions, including deep vein thrombosis (DVT) and certain heart problems. Studies have found that enoxaparin reduces the risk of blood clots more effectively than some other treatments, such as heparin.
However, like any medication, it can cause side effects. The most common concern with enoxaparin is the risk of bleeding, which doctors monitor closely. In one study, some patients experienced major bleeding, but this is uncommon. Overall, enoxaparin is well-tolerated and has a strong safety record across different patient groups.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the enoxaparin sodium injection trial because it explores different dosing regimens that could optimize treatment for blood clots. Unlike the standard once-daily or twice-daily anticoagulant treatments, this trial compares a 30 mg twice-daily regimen with a 40 mg once-daily regimen. The goal is to find the most effective and safe dosing strategy, potentially improving patient outcomes by customizing the anticoagulation approach. This could offer a more tailored and potentially safer option for managing blood clots compared to existing treatments.
What evidence suggests that this trial's treatments could be effective for blood clots?
This trial will compare two dosing regimens of Enoxaparin Sodium Injection for blood clots: 30 mg twice daily and 40 mg once daily. Research has shown that enoxaparin, also known as Lovenox, reduces the risk of blood clots. In one study, 10.1% of patients treated with Lovenox developed blood clots in their veins, compared to 11.3% of those treated with heparin, indicating a slight benefit of Lovenox. Another study found that Lovenox reduced the risk of blood clots by 43% in stroke patients. The FDA has approved enoxaparin for preventing and treating blood clots, highlighting its effectiveness. It also poses a lower risk of causing major bleeding compared to some other treatments. This evidence supports the idea that enoxaparin can be effective for patients at risk of developing clots.13467
Who Is on the Research Team?
Martin A Schreiber, MD
Principal Investigator
Oregon Health and Science University
Are You a Good Fit for This Trial?
This trial is for patients over 15 years old who are at risk of blood clots and need preventive treatment with enoxaparin after trauma or surgery. It's not for those who can't consent, already on a full dose of enoxaparin, using other anticoagulants, have kidney failure needing special doses, or have bleeding in the brain.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive enoxaparin, either 30 mg twice daily or 40 mg once daily, and are monitored for signs and symptoms of blood clots.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including weekly ultrasound duplex examinations of the lower extremities.
What Are the Treatments Tested in This Trial?
Interventions
- Enoxaparin Sodium Injection
Enoxaparin Sodium Injection is already approved in United States, European Union for the following indications:
- Prevention of deep vein thrombosis
- Treatment of acute deep vein thrombosis with or without pulmonary embolism
- Prevention of ischemic complications in unstable angina and non-Q-wave myocardial infarction
- Prevention of deep vein thrombosis
- Treatment of acute deep vein thrombosis with or without pulmonary embolism
- Prevention of ischemic complications in unstable angina and non-Q-wave myocardial infarction
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Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor