A Phase 2/3 interventional study of Anti-Xa Guided Dosing of Low Molecular Weight Heparin and Standard of Care Dosing in Venous Thromboembolism (VTE) and Trauma Related Injuries, sponsored by Alexandre Tran. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-28.
Sponsored by Alexandre Tran · Phase 2/3, Interventional, and Prevention
This multicentre pilot trial will assess the feasibility of a full-scale, randomized trial to determine whether bloodwork guided dosing of blood thinners reduces the risk of clotting in high-risk trauma patients. Patients will receive either standard of care dosing or dosing with adjustments based on bloodwork to achieve a minimum therapeutic threshold.
This multicentre pilot trial will assess the feasibility of a full-scale, randomized trial to determine whether anti-Xa guided dosing of low molecular heparin (LMWH) reduces the risk of venous thromboembolism (VTE) in high-risk trauma patients. Patients will receive either standard of care fixed dosing of Enoxaparin or 0.5 mg/kg twice daily with dose adjustments to achieve an anti-Xa trough level between 0.1 and 0.2 IU/mL.
708 studies on the registry are indexed under Venous Thromboembolism; 152 are open to participants now.
This study's planned enrollment of 150 is below the median of 257 across 390 interventional studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →This is the only study on the registry with Alexandre Tran as lead sponsor.
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To be eligible, patients must be deemed appropriate for pharmacologic prophylaxis by the most responsible physician and randomized with the intention to receive prophylaxis within 48 hours of admission. Prior to randomization, there is no restriction on whether or not patients have previously received pharmacologic or mechanical prophylaxis.
Exclusion Criteria:
Participants will receive Enoxaparin dosed at the discretion of the most responsible physician (MRP). In cases of severe renal insufficiency (CrCl \< 30mL/min\^:), the LMWH may dose reduced or changed to Heparin at the discretion of the MRP.
Drug: Standard of Care Dosing
Participants will receive Enoxaparin 0.5 mg/kg twice daily (rounded up or down to the nearest 10 mg) the initial starting dose. Dose adjustments will be made based on trough levels drawn between the 3rd and 4th dose. The target anti-Xa level range is between 0.1 and 0.2 IU/mL. If the patient is below the target range, then the next Enoxaparin dose will be increased by 10 mg per dose with a new trough anti-Xa level 24 hours after dose modification. If the patient is above the target range, then the next Enoxaparin dose will be decreased by 10 mg per dose with a new trough anti-Xa level 24 hours after dose modification. This dose will be maintained until hospital discharge.
Drug: Anti-Xa Guided Dosing of Low Molecular Weight Heparin
Participants will receive Enoxaparin 0.5 mg/kg twice daily (rounded up or down to the nearest 10 mg) the initial starting dose. Dose adjustments will be made based on trough levels drawn between the 3rd and 4th dose. The target anti-Xa level range is between 0.1 and 0.2 IU/mL. If the patient is below the target range, then the next Enoxaparin dose will be increased by 10 mg per dose with a new trough anti-Xa level 24 hours after dose modification. If the patient is above the target range, then the next Enoxaparin dose will be decreased by 10 mg per dose with a new trough anti-Xa level 24 hours after dose modification. This dose will be maintained until hospital discharge.
Participants will receive Enoxaparin dosed at the discretion of the most responsible physician (MRP). In cases of severe renal insufficiency (CrCl \< 30mL/min\^:), the LMWH may dose reduced or changed to Heparin at the discretion of the MRP.
Recruitment (Patients per site per month)
The pilot trial will have an expected duration of 15 months during which time we hope to enroll at least 150 participants total across all sites - therefore, 5 patients/site/month. There are no maximum enrollment targets for each site.
Time frame: Participants per site per month x 15 months
Eligibility rate
Proportion of screened patients who are eligible
Time frame: 15 months
Consent rate
Proportion of eligible patients who provide consent
Time frame: 15 months
Retention rate
Proportion of participants retained at follow-up
Time frame: 15 months
Study completion rate
Proportion of participants who completed all study procedures
Time frame: 15 months
Adherence rate
Adherence to study drug measured by proportion of prophylaxis doses received.
Time frame: 15 months
Adherence to monitoring
Proportion of patients with anti-Xa tests ordered appropriately
Time frame: 15 months
Adherence to dose adjustment
Proportion of doses adjusted appropriately for anti-Xa level
Time frame: 15 months
Adherence to anti-Xa target
Proportion of patients who achieved target anti-Xa range
Time frame: 15 months
Reasons for declining participation
Reasons for declining participation
Time frame: 15 months
No study locations are listed for this record.
Start is estimated for Jan 2025; primary completion for Jun 2026, 17 months later.
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This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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