Deep Vein ThrombosisDETECTNCT05112705
Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients
A study testing Proximal lower limb ultrasound in people with Deep Vein Thrombosis and Pulmonary Embolism, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolism
- What is being tested?
- Proximal lower limb ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 21 Mar 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdulaziz Medical City
Riyadh, Riyadh Region, 11426
Haifa M Alhumedi, 080111111 ext. 19589, alhumediha@mngha.med.sa
Felwa M Bin Humaid, 08011111 ext. 10819, binhumaidfe1@mngha.med.sa
About this study
Official title: 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.
Read the 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.
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Being tested
- Proximal lower limb ultrasound
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal lower limb ultrasoundDiagnostic test
Twice weekly proximal lower limb ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Group | Active comparator | Patients will be receiving twice weekly proximal lower limb ultrasound Receives: Diagnostic Test: Proximal lower limb ultrasound |
| Control Group | No intervention | Proximal lower limb ultrasound will be performed as per the treating team discretion |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day mortality
Mortality 90 days post randomization
Measured: 90 days
Secondary outcomes (3)
Proximal DVT
Lower limb proximal leg DVT, defined as partially or completely incompressible venous segment.
Measured: 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)
Measured: 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
Measured: From randomization date and throughout hospital stay up to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start21 Mar 2023
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaseen M Arabi, Principal investigator, King Saud bin Abdulaziz University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112705
- Sponsor's protocol ID
- RC 20/257/R
- Acronym
- DETECT
- Status last verified
- Sep 2025
- First submitted
- 26 Oct 2021
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 41161824
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients (DETECT) Trial
- ClinicalTrials.gov ID
- NCT05112705
- Acronym / sponsor ID
- DETECT / RC 20/257/R
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Group | Active comparator | Diagnostic Test: Proximal lower limb ultrasoundPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proximal lower limb ultrasoundTwice weekly proximal lower limb ultrasound | Diagnostic test | Ultrasound Group |
Primary outcome
90-day mortality
Time frame: 90 days
Mortality 90 days post randomization
3 secondary outcomes
Proximal DVT
Time frame: From randomization date to day 28 or ICU discharge whichever comes first
Pulmonary Embolism
Time frame: From randomization date and throughout hospital stay up to day 28
Clinically important bleeding
Time frame: From randomization date and throughout hospital stay up to day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 41161824Arabi 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yaseen M Arabi principal investigator
King Saud bin Abdulaziz University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal lower limb ultrasound in people with Deep Vein Thrombosis and Pulmonary Embolism, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaseen M Arabi (+966118011111 ext. 18899, yaseenarabi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05112705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.