Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients (DETECT) Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,800
- Locations
- 2
- Primary Endpoint
- 90-day mortality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
90-day mortality
Time Frame: 90 days
Mortality 90 days post randomization
Secondary Outcomes
- Proximal DVT(From randomization date to day 28 or ICU discharge whichever comes first)
- Pulmonary Embolism(From randomization date and throughout hospital stay up to day 28)
- Clinically important bleeding(From randomization date and throughout hospital stay up to day 90)