Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients

Study Overview
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Brief Summary
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There is no randomized controlled trial examining surveillance ultrasonography for lower limb DVT in high-risk medical-surgical ICU patients compared to a clinician-directed approach. The DETECT randomized controlled trial addresses the question of whether surveillance ultrasound in critically ill patients by facilitating DVT detection reduces the incidence of PE and lowers all cause 90-day mortality. The primary outcome is 90-day all-cause mortality.

Official Title
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Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients (DETECT) Trial

Conditions
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Deep Vein Thrombosis, Pulmonary Embolism

Intervention / Treatment
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* Diagnostic Test: Proximal lower limb ultrasound


Participation Criteria
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Eligibility Criteria
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Patient in the ICU for more than 2 calendar days Patients with DVT or PE diagnosed within the last year Patients receiving chronic systemic anticoagulation Patients who have received up to the time of ICU admission or are receiving therapeutic dose of anticoagulation with UFH or LMWH or other anticoagulants Inability or contraindication to obtain adequate ultrasound on the lower extremities Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs, large dressings or in the thighs that prevent adequate ultrasounds Acute ischemia in the lower extremities Amputated foot or leg on one or two sides Compartment Syndrome Severe peripheral arterial disease Vein ligation, gangrene, recent vein grafts, and draining incisions Evidence of bone fracture in lower extremities Patients with Inferior Vena Cava (IVC) Filter Known or suspected pregnancy Limitation of life support, life expectancy <7 days or palliative care Previously enrolled in DETECT trial within the last 180 days Enrolled in another trial for which co-enrolment is not approved

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound Group<br>Patients will be receiving twice weekly proximal lower limb ultrasound | Diagnostic Test: Proximal lower limb ultrasound<br>* Twice weekly proximal lower limb ultrasound<br>|
| No Intervention: Control Group<br>Proximal lower limb ultrasound will be performed as per the treating team discretion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day mortality | Mortality 90 days post randomization | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proximal DVT | Incident proximal leg DVT, defined as detected 3 or more days post-randomization and up to ICU discharge | ICU discharge or day 28 post randomization | 
| Secondary outcomes related to proximal lower-extremity DVT | Unilateral/bilateral proximal Lower-extremity DVT including central-venous-catheter- and non-central-venous-catheter-related incident proximal lower-extremity DVT defined as detected 3 or more days post-randomization and up to ICU discharge | ICU discharge or day 28 post randomization | 
| Distal DVT and all lower limb DVTS | Incidence of distal DVT | ICU discharge or day 28 post randomization | 
| Pulmonary Embolism | Pulmonary embolism defined as detected 3 or more days post-randomization and up to ICU discharge | ICU discharge or day 28 post randomization |