DETECT: Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Ultrasound Group Patients will be receiving twice weekly proximal lower limb ultrasound |
Diagnostic Test: Proximal lower limb ultrasound
Twice weekly proximal lower limb ultrasound
|
| No Intervention: Control Group Proximal lower limb ultrasound will be performed as per the treating team discretion |
Outcome Measures
Primary Outcome Measures
- 90-day mortality [90 days]
Mortality 90 days post randomization
Secondary Outcome Measures
- Proximal DVT [ICU discharge or day 28 post randomization]
Incident proximal leg DVT, defined as detected 3 or more days post-randomization and up to ICU discharge
- Secondary outcomes related to proximal lower-extremity DVT [ICU discharge or day 28 post randomization]
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
- Distal DVT and all lower limb DVTS [ICU discharge or day 28 post randomization]
Incidence of distal DVT
- Pulmonary Embolism [ICU discharge or day 28 post randomization]
Pulmonary embolism defined as detected 3 or more days post-randomization and up to ICU discharge
Eligibility Criteria
Criteria
-
Patient in the ICU for more than 2 calendar days
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Patients with DVT or PE diagnosed within the last year
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Patients receiving chronic systemic anticoagulation
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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
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Inability or contraindication to obtain adequate ultrasound on the lower extremities
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Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs, large dressings or in the thighs that prevent adequate ultrasounds
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Acute ischemia in the lower extremities
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Amputated foot or leg on one or two sides
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Compartment Syndrome
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Severe peripheral arterial disease
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Vein ligation, gangrene, recent vein grafts, and draining incisions
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Evidence of bone fracture in lower extremities
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Patients with Inferior Vena Cava (IVC) Filter
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Known or suspected pregnancy
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Limitation of life support, life expectancy <7 days or palliative care
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Previously enrolled in DETECT trial within the last 180 days
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Enrolled in another trial for which co-enrolment is not approved
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- King Abdullah International Medical Research Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC 20/257/R