Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients

Not Applicable

Recruiting

• Conditions: Pulmonary Embolism; Deep Vein Thrombosis
• Interventions: Diagnostic Test: Proximal lower limb ultrasound

• Registration Number: NCT05112705
• Lead Sponsor: King Abdullah International Medical Research Center

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.

Study Timeline

• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-11-08
• Study First Posted: 2021-11-09
• Study Start: 2023-03-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27
• Primary Completion: 2026-03
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound Group	Proximal lower limb ultrasound	Patients will be receiving twice weekly proximal lower limb ultrasound

Primary Outcome Measures

Name	Time	Method
90-day mortality	90 days	Mortality 90 days post randomization

Secondary Outcome Measures

Name	Time	Method
Proximal DVT	From randomization date to day 28 or ICU discharge whichever comes first	Lower limb proximal leg DVT, defined as partially or completely incompressible venous segment.
Pulmonary Embolism	From randomization date and throughout hospital stay up to day 28	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)
Clinically important bleeding	From randomization date and throughout hospital stay up to day 90	Fatal bleeding, symptomatic bleeding in critical organ or bleeding causing fall in hemoglobin, requiring transfusion or interventional radiology

Trial Locations

Locations (1)

King Abdulaziz Medical City; 🇸🇦 Riyadh, Saudi Arabia