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

NCT06662253 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 20240579-01H
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Venous Thromboembolism (VTE); Trauma Related Injuries

Keywords

trauma; venous thromboembolism; prophylaxis

Outcome Measures

Primary Outcomes (1)

• Recruitment (Patients per site per month)

  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.

  Participants per site per month x 15 months

Secondary Outcomes (9)

• Eligibility rate

  15 months

• Consent rate

  15 months

• Retention rate

  15 months

• Study completion rate

  15 months

• Adherence rate

  15 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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.

Drug: Standard of Care Dosing

Intervention (Anti-Xa Guided)

EXPERIMENTAL

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: Anti-Xa Guided Dosing of Low Molecular Weight Heparin

Interventions

Anti-Xa Guided Dosing of Low Molecular Weight Heparin DRUG

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.

Intervention (Anti-Xa Guided)

Standard of Care Dosing DRUG

Participants will receive Enoxaparin dosed at the discretion of the most responsible physician (MRP). In cases of severe renal insufficiency (CrCl \&lt; 30mL/min\^:), the LMWH may dose reduced or changed to Heparin at the discretion of the MRP.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \&lt; 30.
• Expected discharge or transfer from hospital within 72 hours.

Sponsors & Collaborators

• Alexandre Tran: lead

MeSH Terms

Conditions

Venous Thromboembolism; Wounds and Injuries

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alexandre Tran, MD, MSc, FRCSC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Marc Carrier, MD, MSc, FRCPC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Tran, MD, MSc, FRCSC

CONTACT

613-737-8899; aletran@toh.ca

Rebecca Porteous, RN, BNSC, CCRP

CONTACT

613-737-8899; rporteous@ohri.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Scientist

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 28, 2024

Record last verified: 2024-09