Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Proximal lower limb ultrasound
  Twice weekly proximal lower limb ultrasound

Первичные конечные точки

• 90-day mortality [Срок оценки: 90 days]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Саудовская Аравия · 1 центр

• King Abdulaziz Medical City — Riyadh

Публикации

• 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

Идентификаторы

NCT: NCT05112705 · RC 20/257/R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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