Enoxaparin Dosing Regimens for Blood Clots

Overseen By Laura Nguyen

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Oregon Health and Science University

Must be taking: Enoxaparin

Must not be taking: Other anticoagulants

Disqualifiers: Intracranial hemorrhage, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 90 days

606 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 3 4 6 7}

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

I am in the hospital and need preventive blood clot medication.

I am older than 15 years.

I am currently admitted under the care of a trauma or surgical team.

Exclusion Criteria

Unable to obtain consent from patient or authorized representative

I am currently on blood thinners.

I have had bleeding in my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive enoxaparin, either 30 mg twice daily or 40 mg once daily, and are monitored for signs and symptoms of blood clots.

Up to 90 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including weekly ultrasound duplex examinations of the lower extremities.

4 weeks

Weekly visits

What Are the Treatments Tested in This Trial?

Interventions

• Enoxaparin Sodium Injection

Trial Overview The study compares two dosing schedules of enoxaparin: one group receives 30 mg twice daily while another gets 40 mg once daily. The goal is to see which dosage better prevents blood clots without increasing bleeding risks in critical care patients.

How Is the Trial Designed?

Group I: Enoxaparin Sodium Injection 30 mg BID Active Control 1 Intervention

Subjects are randomized to receive 30 mg twice daily of enoxaparin.

Group II: Enoxaparin Sodium Injection 40 mg QD Active Control 1 Intervention

Subjects are randomized to receive 40 mg once daily of enoxaparin.

Enoxaparin Sodium Injection is already approved in United States, European Union for the following indications:

Approved in United States as Lovenox for:

• 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

Approved in European Union as Clexane for:

• 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

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

In a multicenter trial involving 72 hemodialysis patients, an initial dose of 0.5 mg/kg of enoxaparine effectively prevented clotting in nearly half of the patients during dialysis sessions without any complications or side effects.

The study found that 59% of patients required a higher dose (between 0.6 and 0.9 mg/kg) to maintain effective anticoagulation, suggesting that individual patient factors may influence the optimal dosage for preventing thrombotic events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optimization of enoxaparin dose in the prevention of coagulation in the circuits of hemodialysis: results of a multicenter study]. Reach, I., Thébaud, HE., Dupuy, CA., et al.[2006]

Enoxaparin sodium is crucial for treating and preventing thromboembolic complications in COVID-19, but the rise of generic versions has raised concerns about quality and safety, prompting stricter regulatory measures.

The U.S. Pharmacopoeia now requires specific molecular weight determination and the presence of a unique structural feature in generic enoxaparin, allowing for potential approval without animal or human testing if strong analytical similarities are demonstrated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium - A lifesaving carbohydrate polymer. Iqbal, Z., Sadaf, S.[2023]

A patient received an accidental subcutaneous injection of 450 mg Enoxaparin sodium after complex cardiac surgery, leading to severe coagulopathy.

The situation required the transfusion of allogenic blood products, highlighting the risks associated with high doses of anticoagulants like Enoxaparin in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hemorrhage after accidental overdosage of enoxaparin: monitoring and therapy]. Weber, CF., Meybohm, P., Kramer, S., et al.[2014]

Lovenox (Enoxaparin) is an effective anticoagulant used to prevent and treat venous thromboembolism events, administered via subcutaneous injection.

While common side effects like skin reactions typically occur at the injection site, new studies indicate that severe skin and tissue necrosis can also develop at a distance from the injection site, highlighting a potential safety concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lovenox Induced Tissue Necrosis, a Case Report and Literature Review. Issa, AA., Simman, R.[2020]

The Heptest method was used to analyze the effects of two low-molecular-weight heparin (LMWH) drugs, Enoxaparin sodium from Russia and Clexane from France, on blood clotting times, showing that both drugs had similar effects on human plasma.

The study found that Enoxaparin sodium was comparable in efficacy to Clexane, indicating that the domestic version may be a viable alternative to the original drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Analysis of Two Enoxaparin Sodium Drugs by Heptest. Berkovskii, AL., Sergeeva, EV., Chernobrovkin, MG., et al.[2023]

Enoxaparin, a low-molecular-weight heparin, has been approved for use in patients with ST-segment myocardial infarction (STEMI) and has shown to be significantly more effective than unfractionated heparin (UFH) in reducing the incidence of all-cause mortality and recurrent nonfatal myocardial infarction, as demonstrated in the ExTRACT-TIMI 25 trial with a follow-up of 1 year.

While enoxaparin was associated with a higher frequency of bleeding compared to UFH, it still provided a net clinical benefit, indicating its efficacy in preventing serious cardiovascular events in STEMI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enoxaparin: a review of its use in ST-segment elevation myocardial infarction. Carter, NJ., McCormack, PL., Plosker, GL.[2021]

A preclinical study involving 80 rats showed that the biosimilar enoxaparin product 'Enoxa' has a comparable toxicity profile to the reference drug 'Lovenox' at therapeutic and toxic doses, indicating potential safety for use.

Both 'Enoxa' and 'Lovenox' exhibited few adverse effects at a toxic dose of 20 mg/kg/day, with significant mortality only observed at much higher doses, suggesting that 'Enoxa' may be a safe alternative to the original enoxaparin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative subcutaneous repeated toxicity study of enoxaparin products in rats. Kobbi, Z., Kraiem, H., Benlasfar, Z., et al.[2017]

Enoxaparin, administered at a subcutaneous dose of 40 mg daily, is highly effective for antithrombotic prophylaxis after total hip replacement surgery.

The use of enoxaparin showed minor side effects, indicating a good safety profile for patients undergoing this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Enoxaparin (clexane) in the prevention of thromboembolism after total hip replacement]. Babiak, I., Jabłoński, T., Serafin, J.[2014]

Citations

1. lovenox.com lovenox.com/treatment-indications

Proven Outcomes Across All Indications - Lovenox DVT/PE/death occurred in 10.1% (95% CI: 8 to 13) of Lovenox-treated patients and 11.3% (95% CI: 9 to 14) of heparin-treated patients. Adverse Events: Major ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK539865/

Enoxaparin - StatPearls - NCBI Bookshelf - NIH It has FDA approval for the following clinical conditions - acute coronary syndromes, deep venous thrombosis (DVT) treatment and prophylaxis, treatment for ...

3. news.sanofi.us news.sanofi.us/press-releases?item=118375

New study shows LOVENOX® (enoxaparin sodium ... The PREVAIL study showed that in acute ischemic stroke patients treated with Lovenox, the risk of having a VTE was lowered by a significant 43%.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7059046/

An Open-label Randomized Clinical Trial - PubMed Central There was no significant difference in the development of injection site reactions, confusion, and hematuria between two groups of the patients. Table 3.

5. jheor.org jheor.org/article/92408-effectiveness-safety-and-costs-of-thromboprophylaxis-with-enoxaparin-or-unfractionated-heparin-among-medical-inpatients-with-chronic-obstructive-pul

Effectiveness, Safety, and Costs of Thromboprophylaxis ... Enoxaparin recipients had 24% and 10% lower odds of major bleeding and in-hospital mortality during index admission, and 13%, 11%, and 51% lower ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/020164s129lbl.pdf

LOVENOX (enoxaparin sodium) Label - accessdata.fda.gov The incidence of deep vein thrombosis was lower for Lovenox compared to heparin. Extended Prophylaxis of Deep Vein Thrombosis following Hip Replacement ...

7. nejm.org nejm.org/doi/full/10.1056/NEJM199909093411103

A Comparison of Enoxaparin with Placebo for ... In our placebo-controlled study, daily injections of 40 mg of enoxaparin significantly reduced the incidence of venous thromboembolism in ...