Deep Vein Thrombosis, Pulmonary Embolism
Conditions
Brief summary
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.
Detailed description
This is an open-label multicenter multinational randomized-controlled trial. All patients admitted to ICU will be screened within the first 48 hours of ICU admission for eligibility. Subjects who meet all criteria for enrollment will be randomized via a password-protected, secure website using a variable-size block concealed computer-generated randomization procedure. Patients will be allocated to twice weekly bilateral lower limb ultrasound or standard care (control) in a 1:1 ratio.
Interventions
DIAGNOSTIC_TESTProximal lower limb ultrasound
Twice weekly proximal lower limb ultrasound
Sponsors
King Abdullah International Medical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Medical, surgical or trauma ICU patients ≥18 years old. 2. Patients who are expected to stay in the ICU more than 2 calendar days (unlikely to be discharged out of ICU on the day of admission or on the next day).
Exclusion criteria
1. Patients with DVT or PE diagnosed within the last year. 2. Patients receiving chronic systemic anticoagulation. 3. Patients who have received up to the time of ICU admission or are receiving therapeutic doses of anticoagulation with UFH, LMWH, or other anticoagulants. 4. 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 in the thighs that prevent adequate ultrasounds OR amputated foot or leg on one or two sides) 5. Patients with Inferior Vena Cava (IVC) Filter. 6. Known or suspected pregnancy. 7. Limitation of life support, life expectancy \<7 days or palliative care. 8. Previously enrolled in DETECT trial within the last 180 days. 9. Enrolled in another trial for which co-enrolment is not approved.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day mortality | 90 days | Mortality 90 days post randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proximal DVT | From randomization date to day 28 or ICU discharge whichever comes first | Lower limb proximal leg DVT, defined as partially or completely incompressible venous segment. |
| Pulmonary Embolism | From randomization date and throughout hospital stay up to day 28 | Pulmonary embolism defined as definite PE (characteristic intraluminal filling defect on CT chest, high probability VQ scan or detected at autopsy); probable PE (moderate-high pretest, no test or a non-diagnostic test); possible PE (low pre-test probability, non-diagnostic test) or No PE (negative or normal test) |
| Clinically important bleeding | From randomization date and throughout hospital stay up to day 90 | Fatal bleeding, symptomatic bleeding in critical organ or bleeding causing fall in hemoglobin, requiring transfusion or interventional radiology |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vasopressor-free days | 28 days | Total number of days alive and free of vasopressor use within 28 days after randomization |
| Days alive and out of hospital by day 90 | 90 days | Days alive and out of the hospital at day 90 calculated by using the days from alive at hospital discharge to day 90 |
| Mechanical ventilation-free days | 28 days | Total number of days alive and free of mechanical ventilation within 28 days after randomization |
Countries
Saudi Arabia
Contacts
Primary ContactYaseen M Arabi
Backup ContactHaifa Al Humeidi
Outcome results
None listed