Comparing two dosing regimens of Lovenox for preventing blood clots in trauma and surgery patients
A Prospective Randomized Trial Comparing Two Standard Doses of Enoxaparin for the Prevention of Thromboembolism in Surgical Patients
This study is testing whether giving trauma and surgery patients Lovenox twice a day or once a day is better at preventing blood clots and causing fewer bleeding issues.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 606 (estimated) |
| Ages | 15 Years to 100 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT02342444 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness and safety of two dosing regimens of enoxaparin (Lovenox) in preventing blood clots in patients admitted to trauma or surgical services. Participants will be randomized to receive either 30 mg of enoxaparin twice daily or 40 mg once daily. The study will monitor the development of deep vein thrombosis (DVT) and assess any bleeding complications associated with each dosing regimen. Data on patient characteristics and outcomes will be collected throughout the study.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 15 years old who are admitted to trauma or surgical services and require prophylactic dosing of enoxaparin.
Not a fit: Patients who are unable to provide consent, have intracranial hemorrhage, or are receiving therapeutic doses of anticoagulation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the optimal dosing of enoxaparin, potentially reducing the risk of blood clots and associated complications in high-risk patients.
How similar studies have performed: While similar studies have explored enoxaparin dosing, this specific comparison in trauma and surgical patients is novel and has not been directly tested before.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitted patients requiring prophylactic dosing of enoxaparin (Lovenox) * Admitted to the trauma or surgical service * Age greater than 15 years Exclusion Criteria: * 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
Where this trial is running
Portland, Oregon
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Martin A Schreiber, MD — Oregon Health and Science University
- Study coordinator: Laura Nguyen
- Email: nguyelau@ohsu.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.