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Anticoagulant

Enoxaparin Dosing Regimens for Blood Clots

Phase 4
Recruiting
Led By Martin A Schreiber, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitted patients requiring prophylactic dosing of enoxaparin (Lovenox)
Age greater than 15 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily, up to day 90
Awards & highlights

Study Summary

This trial will help determine if a lower dose of enoxaparin given twice daily is as effective as the standard dose of enoxaparin given once daily in preventing blood clots in critically ill patients.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Enoxaparin may cause side effects like bleeding complications, irritation at the injection site, low platelet counts (which helps your blood clot), and allergic reactions. Monitoring will be done to detect these issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in the hospital and need preventive blood clot medication.
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I am older than 15 years.
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I am currently admitted under the care of a trauma or surgical team.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily, up to day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and daily, up to day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Thromboembolic events
Secondary outcome measures
Increase in bleeding complications

Trial Design

2Treatment groups
Active Control
Group I: Enoxaparin Sodium Injection 30 mg BIDActive Control1 Intervention
Subjects are randomized to receive 30 mg twice daily of enoxaparin.
Group II: Enoxaparin Sodium Injection 40 mg QDActive Control1 Intervention
Subjects are randomized to receive 40 mg once daily of enoxaparin.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
7,385,206 Total Patients Enrolled
1 Trials studying Thromboembolism
Martin A Schreiber, MDPrincipal Investigator - Oregon Health and Science University
Oregon Health and Science University
1 Previous Clinical Trials
166 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it a low-risk treatment to administer Enoxaparin Sodium Injection 30 mg BID?

"Since Enoxaparin Sodium Injection 30 mg BID has been approved by the FDA, its safety is rated a 3 out of 3."

Answered by AI

Is this medical experiment actively seeking participants?

"According to the clinicaltrials.gov, this trial is still seeking participants and has been since February 1st 2014. Recent modifications were made on April 14th 2022"

Answered by AI

Could individuals of 40 years and older participate in this research endeavor?

"To take part in this medical experiment, participants must fall between the ages of 15 to 100. Additionally, there are 53 research initiatives for those under 18 and 498 opportunities available to seniors over 65."

Answered by AI

What other experiments have been conducted involving Enoxaparin Sodium Injection 30 mg BID?

"Currently, 20 trials for Enoxaparin Sodium Injection 30 mg BID are ongoing. Out of those active studies, 6 have progressed to Phase 3. Despite the centrality of Saint Louis Missouri as a hub for these trials, other locations across America have 363 sites running tests with this medication."

Answered by AI

Who is the ideal demographic for participating in this research project?

"This medical test requires the enrollment of 606 participants that are between the ages of 15 and 100, and have been diagnosed with venous thrombosis."

Answered by AI

How many individuals are being enlisted in this medical experiment?

"Affirmative. Data accessed on clinicaltrials.gov affirms that this investigation is presently recruiting participants, having been initially posted on February 1st 2014 and revised April 14th 2022. 606 individuals are needed to join the study at a single site."

Answered by AI

What medical ailments can Enoxaparin Sodium Injection 30 mg BID help ameliorate?

"Enoxaparin Sodium Injection 30 mg BID is frequently employed as a treatment for acute chest syndrome. It may also be advantageous in addressing certain outpatients, angina, unstable and ischemic conditions."

Answered by AI
~37 spots leftby Dec 2024