Anti-Xa Guided Dosing of Low Molecular Weight Heparin for Prevention of Venous Thromboembolism Following Traumatic Injury: a Multicentre Pilot Randomized Trial

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexandre Tran

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Anti-Xa Guided Dosing of Low Molecular Weight Heparin
  • Standard of Care Dosing

Treatment groups

150 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Alexandre Tran

Lead sponsor

Ottawa Hospital Research Institute

Sponsor institution