Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Deep Vein Thrombosis Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Ultrasound Group

Patients will be receiving twice weekly proximal lower limb ultrasound

Group Type ACTIVE_COMPARATOR

Proximal lower limb ultrasound

Intervention Type DIAGNOSTIC_TEST

Twice weekly proximal lower limb ultrasound

Control Group

Proximal lower limb ultrasound will be performed as per the treating team discretion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Proximal lower limb ultrasound

Twice weekly proximal lower limb ultrasound

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No