Clinical trial NCT06662253: Anti-Xa Guided Dosing of Low Molecular Weight Heparin for Prevention of Venous Thromboembolism Following Traumatic Injury: a Multicentre Pilot Randomized Trial
Official title: Anti-Xa Guided Dosing of Low Molecular Weight Heparin for Prevention of Venous Thromboembolism Following Traumatic Injury: a Multicentre Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Venous Thromboembolism (VTE)
Trauma Related Injuries
Keywords: trauma
venous thromboembolism
prophylaxis
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

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:

1. Greater than 7 days since time of injury.
2. Requirement for therapeutic anticoagulation or dual-antiplatelet therapy
3. Unable or unwilling to receive pharmacologic prophylaxis within 48 hours of admission.
4. History of allergic reaction or sensitivity to LMWH.
5. Thrombocytopenia with platelets \&lt; 30.
6. Expected discharge or transfer from hospital within 72 hours.

Primary outcomes:
measure: Recruitment (Patients per site per month)
timeFrame: Participants per site per month x 15 months
Secondary outcomes:
measure: Eligibility rate
timeFrame: 15 months
measure: Consent rate
timeFrame: 15 months
measure: Retention rate
timeFrame: 15 months
measure: Study completion rate
timeFrame: 15 months
measure: Adherence rate
timeFrame: 15 months
measure: Adherence to monitoring
timeFrame: 15 months
measure: Adherence to dose adjustment
timeFrame: 15 months
measure: Adherence to anti-Xa target
timeFrame: 15 months
measure: Reasons for declining participation
timeFrame: 15 months
Other outcomes:
Locations:
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Alexandre Tran, MD, MSc, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Marc Carrier, MD, MSc, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: