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

Launched by ALEXANDRE TRAN · Oct 24, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into a new way to give blood thinners to patients who have experienced serious injuries, which can lead to dangerous blood clots known as venous thromboembolism (VTE). The trial will compare two methods of dosing: one will use the standard approach, while the other will adjust the medication based on specific blood tests. The goal is to see if this personalized approach can better prevent blood clots in high-risk trauma patients.

To be eligible for this trial, you must be at least 18 years old and have been admitted to the hospital after a traumatic injury that affects two or more parts of your body, such as your head, chest, or limbs. You also need to meet certain risk factors, like being over 65 years old or having a high body mass index. If you join the trial, you can expect to receive either the standard treatment or the adjusted dosing based on your bloodwork within 48 hours of your hospital admission. It’s important to know that the trial is not yet recruiting participants, so it will take some time before it starts.

Gender

ALL

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 \< 30.
• • 6. Expected discharge or transfer from hospital within 72 hours.