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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
1,800
Twice weekly proximal lower limb ultrasound
King Abdulaziz Medical City
Riyadh, Riyadh Region, Saudi Arabia
RECRUITING90-day mortality
Mortality 90 days post randomization
Time frame: 90 days
Proximal DVT
Lower limb proximal leg DVT, defined as partially or completely incompressible venous segment.
Time frame: From randomization date to day 28 or ICU discharge whichever comes first
Pulmonary Embolism
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)
Time frame: From randomization date and throughout hospital stay up to day 28
Clinically important bleeding
Fatal bleeding, symptomatic bleeding in critical organ or bleeding causing fall in hemoglobin, requiring transfusion or interventional radiology
Time frame: From randomization date and throughout hospital stay up to day 90
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