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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound Group | Active Comparator | Patients will be receiving twice weekly proximal lower limb ultrasound |
|
| Control Group | No Intervention | Proximal lower limb ultrasound will be performed as per the treating team discretion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proximal lower limb ultrasound | Diagnostic Test | Twice weekly proximal lower limb ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| 90-day mortality | Mortality 90 days post randomization | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proximal DVT | Lower limb proximal leg DVT, defined as partially or completely incompressible venous segment. | From randomization date to day 28 or ICU discharge whichever comes first |
| Pulmonary Embolism |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical ventilation-free days | Total number of days alive and free of mechanical ventilation within 28 days after randomization | 28 days |
| Vasopressor-free days | Total number of days alive and free of vasopressor use within 28 days after randomization |
Inclusion criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaseen M Arabi | Contact | +966118011111 | 18899 | yaseenarabi@yahoo.com |
| Haifa Al Humeidi | Contact | +966118011111 | 19589 | alhumediha@mngha.med.sa |
| Name | Affiliation | Role |
|---|---|---|
| Yaseen M Arabi | King Saud bin Abdulaziz University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz Medical City | Recruiting | Riyadh | Riyadh Region | 11426 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41161824 | Derived | 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 patients (DETECT) trial: a protocol for a randomised controlled trial. BMJ Open. 2025 Oct 29;15(10):e104468. doi: 10.1136/bmjopen-2025-104468. |
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The data supporting this study's findings will be available from the corresponding author upon reasonable request as per the regulations of King Abdullah International Medical Research Center (KAIMRC).
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After the publication of the main manuscript (Primary outcome analysis)
Proposal that describes planned analyses must be submitted along with a data sharing agreement
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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)
| From randomization date and throughout hospital stay up to day 28 |
| Clinically important bleeding | Fatal bleeding, symptomatic bleeding in critical organ or bleeding causing fall in hemoglobin, requiring transfusion or interventional radiology | From randomization date and throughout hospital stay up to day 90 |
| 28 days |
| 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 | 90 days |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |