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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Deep Vein Thrombosis; Pulmonary Embolism
• Intervention / Treatment: Diagnostic test: Proximal lower limb ultrasound

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 Type: Interventional
• Enrollment (Estimated): 1800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yaseen M Arabi; Phone Number: 18899 +966118011111; Email: yaseenarabi@yahoo.com
• Study Contact Backup: Name: Haifa Al Humeidi; Phone Number: 19589 +966118011111; Email: alhumediha@mngha.med.sa

Study Locations

• Saudi Arabia
  • Riyadh Region
    • Riyadh, Riyadh Region, Saudi Arabia, 11426
      • Recruiting
      • King Abdulaziz Medical City
      • Contact: Haifa M Alhumedi; Phone Number: 19589 080111111; Email: alhumediha@mngha.med.sa
      • Contact: Felwa M Bin Humaid; Phone Number: 10819 08011111; Email: binhumaidfe1@mngha.med.sa
      • Principal Investigator: Yaseen M Arabi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound Group; Patients will be receiving twice weekly proximal lower limb ultrasound	Diagnostic test: Proximal lower limb ultrasound; Twice weekly proximal lower limb ultrasound
No Intervention: Control Group; Proximal lower limb ultrasound will be performed as per the treating team discretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day mortality	Mortality 90 days post randomization	90 days

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center
• Investigators: Principal Investigator: Yaseen M Arabi, King Saud bin Abdulaziz University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Pulmonary Embolism; Venous Thrombosis
• Other Study ID Numbers: RC 20/257/R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing Time Frame: After the publication of the main manuscript (Primary outcome analysis)
• IPD Sharing Access Criteria: Proposal that describes planned analyses must be submitted along with a data sharing agreement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No