Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients

Official title

Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients (DETECT) Trial

Overview

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.

Interventions

• Diagnostic test Proximal lower limb ultrasound
  Twice weekly proximal lower limb ultrasound

Primary outcome measures

• 90-day mortality [Time frame: 90 days]

Secondary outcome measures (3)

• Proximal DVT [Time frame: From randomization date to day 28 or ICU discharge whichever comes first]
• Pulmonary Embolism [Time frame: From randomization date and throughout hospital stay up to day 28]
• Clinically important bleeding [Time frame: From randomization date and throughout hospital stay up to day 90]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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)
• Patients with Inferior Vena Cava (IVC) Filter.
• Known or suspected pregnancy.
• Limitation of life support, life expectancy <7 days or palliative care.
• Previously enrolled in DETECT trial within the last 180 days.
• Enrolled in another trial for which co-enrolment is not approved.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Screening

Study locations

Saudi Arabia · 1 center

• King Abdulaziz Medical City — Riyadh

Publications

• Arabi YM, Alenezi F, Al-Hameed F, Al Humedi HI, Kharaba A, Alhazzani W, Alshahrani MSS, Algethamy H, Maghrabi K, Chalabi J, Ardah HI, Alahmari AM, AlQahtani RM, Ababtain AA, Al-Filfil WAM, Al-Fares AA, Buabbas SF, Bin Humaid F, Brembali MJ, Amer M, Sadat M, Al Tamimi A, AlHumaidan A, Alqahtani M, Al-Dawood A; Saudi Critical Care Trials Group. Diagnosing deep vein thrombosis early in critically ill PMID 41161824

Identifiers

NCT: NCT05112705 · RC 20/257/R

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗