Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients (DETECT)
Primary Purpose
Deep Vein Thrombosis, Pulmonary Embolism
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Proximal lower limb ultrasound
Sponsored by
About this trial
This is an interventional screening trial for Deep Vein Thrombosis
Eligibility Criteria
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Ultrasound Group
Control Group
Arm Description
Patients will be receiving twice weekly proximal lower limb ultrasound
Proximal lower limb ultrasound will be performed as per the treating team discretion
Outcomes
Primary Outcome Measures
90-day mortality
Mortality 90 days post randomization
Secondary Outcome Measures
Proximal DVT
Incident proximal leg DVT, defined as detected 3 or more days post-randomization and up to ICU discharge
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
Distal DVT and all lower limb DVTS
Incidence of distal DVT
Pulmonary Embolism
Pulmonary embolism defined as detected 3 or more days post-randomization and up to ICU discharge
Full Information
NCT ID
NCT05112705
First Posted
October 26, 2021
Last Updated
March 21, 2023
Sponsor
King Abdullah International Medical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT05112705
Brief Title
Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients
Acronym
DETECT
Official Title
Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients (DETECT) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Abdullah International Medical Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Pulmonary Embolism
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound Group
Arm Type
Active Comparator
Arm Description
Patients will be receiving twice weekly proximal lower limb ultrasound
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Proximal lower limb ultrasound will be performed as per the treating team discretion
Intervention Type
Diagnostic Test
Intervention Name(s)
Proximal lower limb ultrasound
Intervention Description
Twice weekly proximal lower limb ultrasound
Primary Outcome Measure Information:
Title
90-day mortality
Description
Mortality 90 days post randomization
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Proximal DVT
Description
Incident proximal leg DVT, defined as detected 3 or more days post-randomization and up to ICU discharge
Time Frame
ICU discharge or day 28 post randomization
Title
Secondary outcomes related to proximal lower-extremity DVT
Description
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
Time Frame
ICU discharge or day 28 post randomization
Title
Distal DVT and all lower limb DVTS
Description
Incidence of distal DVT
Time Frame
ICU discharge or day 28 post randomization
Title
Pulmonary Embolism
Description
Pulmonary embolism defined as detected 3 or more days post-randomization and up to ICU discharge
Time Frame
ICU discharge or day 28 post randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaseen Arabi
Phone
+966118011111
Email
yaseenarabi@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients
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