Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients

Pulmonary Embolism Clinical Trial

— DETECT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05112705
• Other study ID #: RC 20/257/R
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: January 2026

Study information

• Verified date: March 2023
• Source: King Abdullah International Medical Research Center
• Contact: Yaseen Arabi
• Phone: +966118011111
• Email: yaseenarabi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is no randomized controlled trial examining surveillance ultrasonography for lower limb DVT in high-risk medical-surgical ICU patients compared to a clinician-directed approach. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1800
• Est. completion date: January 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• Patient in the ICU for more than 2 calendar days
• 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 dose of anticoagulation with UFH or 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 or in the thighs that prevent adequate ultrasounds
• Acute ischemia in the lower extremities
• Amputated foot or leg on one or two sides
• Compartment Syndrome
• Severe peripheral arterial disease
• Vein ligation, gangrene, recent vein grafts, and draining incisions
• Evidence of bone fracture in lower extremities
• 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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Diagnostic Test:
• Proximal lower limb ultrasound
Twice weekly proximal lower limb ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day mortality	Mortality 90 days post randomization	90 days
Secondary	Proximal DVT	Incident proximal leg DVT, defined as detected 3 or more days post-randomization and up to ICU discharge	ICU discharge or day 28 post randomization
Secondary	Secondary outcomes related to proximal lower-extremity DVT	Unilateral/bilateral proximal Lower-extremity DVT including central-venous-catheter- and non-central-venous-catheter-related incident proximal lower-extremity DVT defined as detected 3 or more days post-randomization and up to ICU discharge	ICU discharge or day 28 post randomization
Secondary	Distal DVT and all lower limb DVTS	Incidence of distal DVT	ICU discharge or day 28 post randomization
Secondary	Pulmonary Embolism	Pulmonary embolism defined as detected 3 or more days post-randomization and up to ICU discharge	ICU discharge or day 28 post randomization