Trauma Related Injuries, Venous Thromboembolism (VTE)
Conditions
Keywords
trauma, venous thromboembolism, prophylaxis
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.
Interventions
DRUGAnti-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.
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.
Sponsors
Alexandre Tran
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 < 30. 6. Expected discharge or transfer from hospital within 72 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment (Patients per site per month) | Participants per site per month x 15 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consent rate | 15 months | Proportion of eligible patients who provide consent |
| Retention rate | 15 months | Proportion of participants retained at follow-up |
| Study completion rate | 15 months | Proportion of participants who completed all study procedures |
| Adherence rate | 15 months | Adherence to study drug measured by proportion of prophylaxis doses received. |
| Eligibility rate | 15 months | Proportion of screened patients who are eligible |
| Adherence to dose adjustment | 15 months | Proportion of doses adjusted appropriately for anti-Xa level |
| Adherence to anti-Xa target | 15 months | Proportion of patients who achieved target anti-Xa range |
| Reasons for declining participation | 15 months | Reasons for declining participation |
| Adherence to monitoring | 15 months | Proportion of patients with anti-Xa tests ordered appropriately |
Contacts
Primary ContactAlexandre Tran, MD, MSc, FRCSC
Backup ContactRebecca Porteous, RN, BNSC, CCRP
Outcome results
None listed