Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Abdullah International Medical Research Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Medical, surgical or trauma ICU patients ≥18 years old.
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).
Disqualifiers
Patients with DVT or PE diagnosed within the last year.
Patients receiving chronic systemic anticoagulation.
Patients who have received up to the time of ICU admission or are receiving therapeutic doses of anticoagulation with UFH, LMWH, or other anticoagulants.
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Proximal lower limb ultrasound
Diagnostic testTwice weekly proximal lower limb ultrasound
Treatment groups
1,800 Participants
are divided into 2 treatment groupsGroup A: Ultrasound GroupActive comparator 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
90-day mortality
Mortality 90 days post randomization
Time frame
90 daysSecondary outcomes
1
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 first2
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 283
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 90Other outcomes
1
Mechanical ventilation-free days
Total number of days alive and free of mechanical ventilation within 28 days after randomization
Time frame
28 days2
Vasopressor-free days
Total number of days alive and free of vasopressor use within 28 days after randomization
Time frame
28 days3
Days alive and out of hospital by day 90
Days alive and out of the hospital at day 90 calculated by using the days from alive at hospital discharge to day 90
Time frame
90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov