Anti-Xa Guided Dosing of Low Molecular Weight Heparin for Prevention of Venous Thromboembolism Following Traumatic Injury: a Multicentre Pilot Randomized Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anti-Xa Guided Dosing of Low Molecular Weight Heparin, Standard of Care Dosing.
- Who it may be relevant to
- Registry conditions: Venous Thromboembolism (VTE), Trauma Related Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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 t - 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.
Primary outcome measures
- Recruitment (Patients per site per month) [Time frame: Participants per site per month x 15 months]
Secondary outcome measures (9)
- Eligibility rate [Time frame: 15 months]
- Consent rate [Time frame: 15 months]
- Retention rate [Time frame: 15 months]
- Study completion rate [Time frame: 15 months]
- Adherence rate [Time frame: 15 months]
- Adherence to monitoring [Time frame: 15 months]
- Adherence to dose adjustment [Time frame: 15 months]
- Adherence to anti-Xa target [Time frame: 15 months]
- Reasons for declining participation [Time frame: 15 months]
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
- 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.
- Thrombocytopenia with platelets \< 30.
- Expected discharge or transfer from hospital within 72 hours.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06662253 · 20240579-01H