NCT05112705

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Mar 2023Dec 2026

First Submitted

Initial submission to the registry

October 26, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2.9 years

First QC Date

October 26, 2021

Last Update Submit

September 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 90-day mortality

    Mortality 90 days post randomization

    90 days

Secondary Outcomes (3)

  • Proximal DVT

    From randomization date to day 28 or ICU discharge whichever comes first

  • Pulmonary Embolism

    From randomization date and throughout hospital stay up to day 28

  • Clinically important bleeding

    From randomization date and throughout hospital stay up to day 90

Other Outcomes (3)

  • Mechanical ventilation-free days

    28 days

  • Vasopressor-free days

    28 days

  • Days alive and out of hospital by day 90

    90 days

Study Arms (2)

Ultrasound Group

ACTIVE COMPARATOR

Patients will be receiving twice weekly proximal lower limb ultrasound

Diagnostic Test: Proximal lower limb ultrasound

Control Group

NO INTERVENTION

Proximal lower limb ultrasound will be performed as per the treating team discretion

Interventions

Twice weekly proximal lower limb ultrasound

Ultrasound Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz Medical City

Riyadh, Riyadh Region, 11426, Saudi Arabia

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Venous ThrombosisPulmonary Embolism

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Yaseen M Arabi

    King Saud bin Abdulaziz University of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 9, 2021

Study Start

March 21, 2023

Primary Completion

March 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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).

Time Frame
After the publication of the main manuscript (Primary outcome analysis)
Access Criteria
Proposal that describes planned analyses must be submitted along with a data sharing agreement

Locations