Venous Thromboembolism (VTE)Phase 2/3PrOVE iTNCT06662253
Anti-Xa Guided Dosing of Low Molecular Weight Heparin for Prevention of Venous Thromboembolism Following Traumatic Injury: a Multicentre Pilot Randomized Trial
A Phase 2/3 study testing Anti-Xa Guided Dosing of Low Molecular Weight Heparin in people with Venous Thromboembolism (VTE) and Trauma Related Injuries, run by Alexandre Tran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism (VTE), Trauma Related Injuries
- What is being tested?
- Anti-Xa Guided Dosing of Low Molecular Weight Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Sep 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- Anti-Xa Guided Dosing of Low Molecular Weight Heparin, Standard of Care Dosing
- Keywords
- trauma, venous thromboembolism, prophylaxis
- Medical subject headings
- Venous Thromboembolism, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Xa Guided Dosing of Low Molecular Weight HeparinDrug
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.
Standard of Care DosingDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Anti-Xa Guided Dosing of Low Molecular Weight Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants per site per month x 15 months
Secondary outcomes (9)
Eligibility rate
Proportion of screened patients who are eligible
Measured: 15 months
Consent rate
Proportion of eligible patients who provide consent
Measured: 15 months
Retention rate
Proportion of participants retained at follow-up
Measured: 15 months
Study completion rate
Proportion of participants who completed all study procedures
Measured: 15 months
Adherence rate
Adherence to study drug measured by proportion of prophylaxis doses received.
Measured: 15 months
Adherence to monitoring
Proportion of patients with anti-Xa tests ordered appropriately
Measured: 15 months
Adherence to dose adjustment
Proportion of doses adjusted appropriately for anti-Xa level
Measured: 15 months
Adherence to anti-Xa target
Proportion of patients who achieved target anti-Xa range
Measured: 15 months
Reasons for declining participation
Reasons for declining participation
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study startJan 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolism (VTE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandre Tran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexandre Tran, Ottawa Hospital Research Institute
- Investigators
- Alexandre Tran, MD, MSc, FRCSC, Principal investigator, Ottawa Hospital Research InstituteMarc Carrier, MD, MSc, FRCPC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662253
- Sponsor's protocol ID
- 20240579-01H
- Acronym
- PrOVE iT
- Status last verified
- Sep 2024
- First submitted
- 24 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Xa Guided Dosing of Low Molecular Weight Heparin for Prevention of Venous Thromboembolism Following Traumatic Injury: a Multicentre Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT06662253
- Acronym / sponsor ID
- PrOVE iT / 20240579-01H
- Keywords
- trauma, venous thromboembolism, prophylaxis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Alexandre TranUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: Standard of Care DosingParticipants 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. |
| Intervention (Anti-Xa Guided) | Experimental | Drug: Anti-Xa Guided Dosing of Low Molecular Weight HeparinParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-Xa Guided Dosing of Low Molecular Weight HeparinParticipants 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 | Intervention (Anti-Xa Guided) |
| Standard of Care DosingParticipants 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 |
Primary outcome
Recruitment (Patients per site per month)
Time frame: 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.
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Tran, MD, MSc, FRCSC principal investigator
Ottawa Hospital Research Institute
Marc Carrier, MD, MSc, FRCPC principal investigator
Ottawa Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anti-Xa Guided Dosing of Low Molecular Weight Heparin in people with Venous Thromboembolism (VTE) and Trauma Related Injuries, run by Alexandre Tran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Tran, MD, MSc, FRCSC (613-737-8899 ext. 17076, aletran@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (Patients per site per month) (time frame: Participants per site per month x 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.