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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
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
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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