Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-27 @ 1:55 AM
Study NCT ID:
NCT04486859
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-02
First Post:
2020-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Thrombosis Prevention in Patients With CD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047748', 'term': 'Pituitary ACTH Hypersecretion'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-12', 'size': 571258, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-29T22:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 206}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-29', 'studyFirstSubmitDate': '2020-07-22', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VTE incidence rate', 'timeFrame': '12 weeks', 'description': 'DVT and PE incidence in 12 weeks after surgery'}], 'secondaryOutcomes': [{'measure': 'DVT incidence rate', 'timeFrame': '12 weeks', 'description': 'DVT in 12 weeks after surgery'}, {'measure': 'PE incidence rate', 'timeFrame': '12 weeks', 'description': 'PE in 12 weeks after surgery'}, {'measure': 'Mortality', 'timeFrame': '12 weeks', 'description': 'All-cause Mortality and VTE-specific Mortality'}, {'measure': 'Symptomatic VTE incidence rate', 'timeFrame': '12 weeks', 'description': 'Symptomatic DVT and PE incidence in 12 weeks after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cushing Disease', 'DVT', 'Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '40544300', 'type': 'DERIVED', 'citation': "Qiao N, He M, Ye Z, Gong W, Ma Z, Yu Y, Wu Z, Lu L, Zhu H, Yao Y, Liao Z, Wang H, Tan H, Cai B, Yu Y, Lei T, Yang Y, Jiang C, Yan X, Guo Y, Chen Y, Ye H, Wang Y, Tritos NA, Zhang Z, Zhao Y. Postoperative Initiation of Thromboprophylaxis in patients with Cushing's Disease (PIT-CD): a randomized controlled trial. Trials. 2025 Jun 21;26(1):217. doi: 10.1186/s13063-025-08923-6."}]}, 'descriptionModule': {'briefSummary': 'Patients with Cushing disease was randomized to 2 groups. After surgery, the patients were managed with mechanical prevention or mechanical prevention plus anticoagulant drugs(LMWH followed by rivaroxaban), VTE was observed 24h, 5day, 4weeks and 12weeks after surgery.Bleeding events were also recorded.', 'detailedDescription': "Cushing disease, caused by ACTH-secreting pituitary adenomas, can lead to serious complications with increased mortality. Minimally invasive surgery is currently the preferred treatment for the disease, allowing more than 80% of tumors to be completely removed. However, postoperative venous thrombosis (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) pose great threats to patients' safety. According to the literatures and the data from our center, up to 27% of the patients with Cushing's disease developed VTE after surgery. Due to the lacking of a randomized prospective study, there is no consensus or guideline on preventative anticoagulation protocols for postoperative management in patients with Cushing's disease. This is a prospective randomized control study on preventative anticoagulation in patients with Cushing's disease after transsphenoidal resection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cushing\\'s disease diagnosed and treated with transsphenoid surgery at study centers\n\nExclusion Criteria:\n\n1. History of VTE before surgery or within 24 hours post-surgery\n2. Acute bacterial endocarditis\n3. Major bleeding events\n4. Thrombocytopenia\n5. Active gastrointestinal ulcers\n6. History of stroke\n7. High risk of bleeding due to clotting abnormalities\n8. Participation in other clinical trials within the last three months\n9. Contraindications to rivaroxaban (e.g., renal dysfunction with eGFR \\< 50 mL/min)\n10. Presence of other malignant diseases\n11. Severe mental or neurological disorders\n12. Presence of intracranial vascular abnormalities\n13. Contraindications to mechanical prophylactic anticoagulation\n14. Pregnancy\n15. Any other condition that researchers deem inappropriate for study participation.'}, 'identificationModule': {'nctId': 'NCT04486859', 'acronym': 'PIT-CD', 'briefTitle': 'Postoperative Thrombosis Prevention in Patients With CD', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': "A Prospective, Multicenter, Randomized Controlled Study of Postoperative Initiation of Thromboprophylaxis in Patients With Cushing's Disease", 'orgStudyIdInfo': {'id': 'KY2020-794'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'mechanical prevention', 'description': 'patients were managed with IPC', 'interventionNames': ['Device: IPC']}, {'type': 'OTHER', 'label': 'mechanical plus anticoagulant drugs prevention', 'description': 'patients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery', 'interventionNames': ['Drug: LMWH/Rivaroxaban', 'Device: IPC']}], 'interventions': [{'name': 'LMWH/Rivaroxaban', 'type': 'DRUG', 'description': 'combined prevention', 'armGroupLabels': ['mechanical plus anticoagulant drugs prevention']}, {'name': 'IPC', 'type': 'DEVICE', 'description': 'mechanical prevention', 'armGroupLabels': ['mechanical plus anticoagulant drugs prevention', 'mechanical prevention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350004', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'The First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Sun Yat sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'China West Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '830001', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': "People's Hopital of Xinjiang Uygur Autonomous Region", 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice director of endocrine department', 'investigatorFullName': 'Zhaoyun Zhang', 'investigatorAffiliation': 'Huashan Hospital'}}}}