Clinical trial NCT05112705: Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients
Official title: Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients (DETECT) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 90-day mortality
timeFrame: 90 days
Secondary outcomes:
measure: Proximal DVT
timeFrame: From randomization date to day 28 or ICU discharge whichever comes first
measure: Pulmonary Embolism
timeFrame: From randomization date and throughout hospital stay up to day 28
measure: Clinically important bleeding
timeFrame: From randomization date and throughout hospital stay up to day 90
Other outcomes:
measure: Mechanical ventilation-free days
timeFrame: 28 days
measure: Vasopressor-free days
timeFrame: 28 days
measure: Days alive and out of hospital by day 90
timeFrame: 90 days
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City
Study officials:
affiliation: King Saud bin Abdulaziz University of Health Sciences
name: Yaseen M Arabi
role: PRINCIPAL_INVESTIGATOR
References: