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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mechanical prevention | Other | patients were managed with IPC |
|
| mechanical plus anticoagulant drugs prevention | Other | patients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMWH/Rivaroxaban | Drug | combined prevention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| VTE incidence rate | DVT and PE incidence in 12 weeks after surgery | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| DVT incidence rate | DVT in 12 weeks after surgery | 12 weeks |
| PE incidence rate | PE in 12 weeks after surgery | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350004 | China | ||
| The First Affiliated Hospital of Sun Yat sen University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40544300 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2025 | Jun 29, 2025 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D047748 | Pituitary ACTH Hypersecretion |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
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| IPC |
| Device |
mechanical prevention |
|
| Mortality | All-cause Mortality and VTE-specific Mortality | 12 weeks |
| Symptomatic VTE incidence rate | Symptomatic DVT and PE incidence in 12 weeks after surgery | 12 weeks |
| Guangzhou |
| Guangdong |
| 510000 |
| China |
| Tongji Hospital | Wuhan | Hubei | 430000 | China |
| Huashan Hospital | Shanghai | Shanghai Municipality | 200040 | China |
| China West Hospital | Chengdu | Sichuan | 610041 | China |
| People's Hopital of Xinjiang Uygur Autonomous Region | Ürümqi | Xinjiang | 830001 | China |
| Peking Union Medical College Hospital | Beijing | China |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |