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

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

September 30, 2026

Conditions
Venous Thromboembolism (VTE)Trauma Related Injuries
Interventions
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.

DRUG

Standard of Care Dosing

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.

All Listed Sponsors
lead

Alexandre Tran

OTHER

NCT06662253 - Anti-Xa Guided Dosing of Low Molecular Weight Heparin for Prevention of Venous Thromboembolism Following Traumatic Injury: a Multicentre Pilot Randomized Trial | Biotech Hunter | Biotech Hunter