Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT05112705
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2021-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2021-10-26', 'studyFirstSubmitQcDate': '2021-11-08', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mechanical ventilation-free days', 'timeFrame': '28 days', 'description': 'Total number of days alive and free of mechanical ventilation within 28 days after randomization'}, {'measure': 'Vasopressor-free days', 'timeFrame': '28 days', 'description': 'Total number of days alive and free of vasopressor use within 28 days after randomization'}, {'measure': 'Days alive and out of hospital by day 90', 'timeFrame': '90 days', 'description': 'Days alive and out of the hospital at day 90 calculated by using the days from alive at hospital discharge to day 90'}], 'primaryOutcomes': [{'measure': '90-day mortality', 'timeFrame': '90 days', 'description': 'Mortality 90 days post randomization'}], 'secondaryOutcomes': [{'measure': 'Proximal DVT', 'timeFrame': 'From randomization date to day 28 or ICU discharge whichever comes first', 'description': 'Lower limb proximal leg DVT, defined as partially or completely incompressible venous segment.'}, {'measure': 'Pulmonary Embolism', 'timeFrame': 'From randomization date and throughout hospital stay up to day 28', 'description': '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)'}, {'measure': 'Clinically important bleeding', 'timeFrame': 'From randomization date and throughout hospital stay up to day 90', 'description': 'Fatal bleeding, symptomatic bleeding in critical organ or bleeding causing fall in hemoglobin, requiring transfusion or interventional radiology'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deep Vein Thrombosis', 'Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '41161824', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Medical, surgical or trauma ICU patients ≥18 years old.\n2. 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).\n\nExclusion Criteria\n\n1. Patients with DVT or PE diagnosed within the last year.\n2. Patients receiving chronic systemic anticoagulation.\n3. Patients who have received up to the time of ICU admission or are receiving therapeutic doses of anticoagulation with UFH, LMWH, or other anticoagulants.\n4. 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)\n5. Patients with Inferior Vena Cava (IVC) Filter.\n6. Known or suspected pregnancy.\n7. Limitation of life support, life expectancy \\<7 days or palliative care.\n8. Previously enrolled in DETECT trial within the last 180 days.\n9. Enrolled in another trial for which co-enrolment is not approved.'}, 'identificationModule': {'nctId': 'NCT05112705', 'acronym': 'DETECT', 'briefTitle': 'Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'King Abdullah International Medical Research Center'}, 'officialTitle': 'Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients (DETECT) Trial', 'orgStudyIdInfo': {'id': 'RC 20/257/R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound Group', 'description': 'Patients will be receiving twice weekly proximal lower limb ultrasound', 'interventionNames': ['Diagnostic Test: Proximal lower limb ultrasound']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Proximal lower limb ultrasound will be performed as per the treating team discretion'}], 'interventions': [{'name': 'Proximal lower limb ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Twice weekly proximal lower limb ultrasound', 'armGroupLabels': ['Ultrasound Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11426', 'city': 'Riyadh', 'state': 'Riyadh Region', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Haifa M Alhumedi', 'role': 'CONTACT', 'email': 'alhumediha@mngha.med.sa', 'phone': '080111111', 'phoneExt': '19589'}, {'name': 'Felwa M Bin Humaid', 'role': 'CONTACT', 'email': 'binhumaidfe1@mngha.med.sa', 'phone': '08011111', 'phoneExt': '10819'}, {'name': 'Yaseen M Arabi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'King Abdulaziz Medical City', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'centralContacts': [{'name': 'Yaseen M Arabi', 'role': 'CONTACT', 'email': 'yaseenarabi@yahoo.com', 'phone': '+966118011111', 'phoneExt': '18899'}, {'name': 'Haifa Al Humeidi', 'role': 'CONTACT', 'email': 'alhumediha@mngha.med.sa', 'phone': '+966118011111', 'phoneExt': '19589'}], 'overallOfficials': [{'name': 'Yaseen M Arabi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Saud bin Abdulaziz University of Health Sciences'}]}, 'ipdSharingStatementModule': {'timeFrame': 'After the publication of the main manuscript (Primary outcome analysis)', 'ipdSharing': 'YES', '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).", 'accessCriteria': 'Proposal that describes planned analyses must be submitted along with a data sharing agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdullah International Medical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}