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.
Patients 18 years of age or older admitted to a hospital ward or intensive care unit following a traumatic injury involving two or more body systems (head, chest, abdomen, pelvis, extremity) and meeting at least one of the following high-risk criteria previously identified in a recent systematic review (1): age ≥ 65, body mass index ≥ 30 kg/m2, injury severity score ≥ 16, pelvic injury with activity restrictions, lower extremity injury with activity restrictions, or surgery during the index hospitalization.
Greater than 7 days since time of injury.
Requirement for therapeutic anticoagulation or dual-antiplatelet therapy
Unable or unwilling to receive pharmacologic prophylaxis within 48 hours of admission.
History of allergic reaction or sensitivity to LMWH.
Single group
Anti-Xa Guided Dosing of Low Molecular Weight Heparin
DrugParticipants 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.
Standard of Care Dosing
DrugParticipants 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.
Eligibility rate
Proportion of screened patients who are eligible
Consent rate
Proportion of eligible patients who provide consent
Retention rate
Proportion of participants retained at follow-up
Study completion rate
Proportion of participants who completed all study procedures
Click on the lead sponsor to view all of their trials.
Alexandre Tran
Lead sponsor
Ottawa Hospital Research Institute
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
