Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 10:18 PM
Study NCT ID:
NCT07330661
Status:
COMPLETED
Last Update Posted:
2026-01-12
First Post:
2025-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nursing-Led Deep Vein Thrombosis Prevention in Neurosurgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1286}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-08', 'studyFirstSubmitDate': '2025-12-28', 'studyFirstSubmitQcDate': '2025-12-28', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of objectively confirmed lower-extremity deep-vein thrombosis (DVT)', 'timeFrame': '30 days', 'description': 'diagnosed by blinded duplex ultrasound using standard non-compressibility or intraluminal thrombus criteria.'}], 'secondaryOutcomes': [{'measure': 'Time from surgery to first objectively confirmed DVT (days)', 'timeFrame': '30 days', 'description': 'Time from surgery to first objectively confirmed DVT (days)'}, {'measure': 'All-cause mortality within 30 days', 'timeFrame': '30 days', 'description': 'All-cause mortality within 30 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurosurgery', 'Interdisciplinary Nursing', 'Multimodal Prevention', 'Risk Prediction', 'Randomized Controlled Trial'], 'conditions': ['Deep Vein Thrombosis (DVT)']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to see if a nurse-led program (early movement, leg-sleeve squeezes, and blood tests) can prevent dangerous leg blood clots in adults who have just had brain or spine surgery.\n\nMain questions it aims to answer:\n\n* Does the program lower the number of clots within 30 days after surgery?\n* Is the program safer and more accurate than the usual clot-risk score nurses already use?\n\nResearchers will compare patients who receive the nurse-led program with patients who receive standard hospital care.\n\nParticipants will:\n\n* Be randomly assigned to one of the two groups.\n* Have regular leg ultrasounds to check for clots.\n* Wear a small activity tracker if they are in the nurse-led group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age ≥ 18 years\n* Any elective or emergency craniotomy, spinal, or other neurosurgical procedure\n* Expected post-operative hospital stay ≥ 3 days\n* Patient or legally authorized representative willing and able to give written informed consent\n\nExclusion Criteria\n\n* Pre-operative ultrasound or imaging proven DVT or pulmonary embolism\n* Known hereditary bleeding disorder (e.g., hemophilia) or platelet count \\< 50 × 10⁹/L\n* Chronic therapeutic anticoagulation (warfarin, DOAC, heparin) that cannot be safely stopped, or need for full-dose post-op anticoagulation\n* Severe liver disease (Child-Pugh class C) or eGFR \\< 30 mL/min/1.73 m²\n* Life-limiting co-morbidity with expected survival \\< 30 days\n* Pregnancy or breastfeeding\n* Current participation in another interventional VTE trial'}, 'identificationModule': {'nctId': 'NCT07330661', 'briefTitle': 'Nursing-Led Deep Vein Thrombosis Prevention in Neurosurgery', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Neurointerdisciplinary Nursing Prevention Strategies for Deep Vein Thrombosis (DVT) After Neurosurgical Procedures: A Multicenter Randomized Controlled Trial and Nomogram Development', 'orgStudyIdInfo': {'id': 'WestChinaH-HX-2025-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nurse-led prevention group', 'description': 'In addition to routine post-operative care, participants assigned to the nurse-led prevention arm receive:\n\n* Graded early-movement plan starting within 24 h of surgery\n* Unconscious patients: passive leg exercises 10-15 min, 3× daily\n* Conscious patients: assisted leg, sitting and walking sessions escalated daily (target ≥ 40 min total activity, logged automatically by a wrist-band activity tracker)\n* Intermittent pneumatic compression (IPC)\n* 2 h/session, 2× daily, 30-45 mmHg while in bed, continued until independent walking\n* D-dimer blood checks on post-op days 1, 3, 7 and 14; any rise ≥ 20 % or level \\> 2 mg/L triggers an extra leg ultrasound\n* Continuous safety watch (heart rate, blood pressure, intracranial pressure if monitored); IPC or movement is paused if pressure \\> 20 mmHg or vital signs become unstable\n\nAll steps are recorded in the electronic nursing chart and coordinated by a neurosurgery-rehabilitation-data', 'interventionNames': ['Behavioral: nurse-led program (early movement, leg-sleeve squeezes, and blood tests)']}, {'type': 'NO_INTERVENTION', 'label': 'Standard post-neurosurgical care group', 'description': "Participants in the control arm receive the hospital's standard post-neurosurgical care, which follows current Chinese and U.S. VTE-guidelines and includes:\n\n* Routine hydration and general health-education advice\n* Graduated compression stockings (class II, knee-high) worn 8-12 h each day until the patient is walking independently\n* Gentle passive leg movements (about 10 min, 1-2 times daily) when nursing staff judge it safe\n* Low-molecular-weight heparin (40 mg enoxaparin subcutaneous once daily) only for patients judged to be at low bleeding risk (Caprini 4-7) and with no intracranial hemorrhage\n\nNo systematic Caprini re-assessments, no scheduled early-mobilization protocol, no IPC machines, no D-dimer surveillance, and no activity trackers are used."}], 'interventions': [{'name': 'nurse-led program (early movement, leg-sleeve squeezes, and blood tests)', 'type': 'BEHAVIORAL', 'description': 'Graded early-movement plan starting within 24 h of surgery\n\n* Unconscious patients: passive leg exercises 10-15 min, 3× daily\n* Conscious patients: assisted leg, sitting and walking sessions escalated daily (target ≥ 40 min total activity, logged automatically by a wrist-band activity tracker) Intermittent pneumatic compression (IPC)\n* 2 h/session, 2× daily, 30-45 mmHg while in bed, continued until independent walking D-dimer blood checks on post-op days 1, 3, 7 and 14; any rise ≥ 20 % or level \\> 2 mg/L triggers an extra leg ultrasound Continuous safety watch (heart rate, blood pressure, intracranial pressure if monitored); IPC or movement is paused if pressure \\> 20 mmHg or vital signs become unstable', 'armGroupLabels': ['Nurse-led prevention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhigang Lan', 'investigatorAffiliation': 'West China Hospital'}}}}