Postoperative Initiation of Thromboprophylaxis in patients with Cushing’s Disease (PIT-CD): a randomized controlled trial
Abstract Background Pituitary surgical intervention remains the preferred treatment for Cushing’s disease (CD) while postoperative venous thromboembolism (VTE) is a significant risk. Whether to prescribe pharmacological thromboprophylaxis presents a clinical dilemma, balancing the benefit of reducin...
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2025-06-01
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| Online Access: | https://doi.org/10.1186/s13063-025-08923-6 |
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| author | Nidan Qiao Min He Zhao Ye Wei Gong Zengyi Ma Yifei Yu Zhenyu Wu Lin Lu Huijuan Zhu Yong Yao Zhihong Liao Haijun Wang Huiwen Tan Bowen Cai Yerong Yu Ting Lei Yan Yang Changzhen Jiang Xiaofang Yan Yanying Guo Yuan Chen Hongying Ye Yongfei Wang Nicholas A. Tritos Zhaoyun Zhang Yao Zhao |
| author_facet | Nidan Qiao Min He Zhao Ye Wei Gong Zengyi Ma Yifei Yu Zhenyu Wu Lin Lu Huijuan Zhu Yong Yao Zhihong Liao Haijun Wang Huiwen Tan Bowen Cai Yerong Yu Ting Lei Yan Yang Changzhen Jiang Xiaofang Yan Yanying Guo Yuan Chen Hongying Ye Yongfei Wang Nicholas A. Tritos Zhaoyun Zhang Yao Zhao |
| author_sort | Nidan Qiao |
| collection | DOAJ |
| description | Abstract Background Pituitary surgical intervention remains the preferred treatment for Cushing’s disease (CD) while postoperative venous thromboembolism (VTE) is a significant risk. Whether to prescribe pharmacological thromboprophylaxis presents a clinical dilemma, balancing the benefit of reducing VTE risk with the potential for increasing hemorrhagic events in these patients. Currently, strong evidence and established protocols for routine pharmacological thromboprophylaxis in this population are lacking. Therefore, a randomized, controlled trial is warranted to determine the efficacy and safety of combined pharmacological and mechanical thromboprophylaxis in reducing postoperative VTE risk in patients with CD. Methods This investigator-initiated, multi-center, prospective, randomized, open-label trial with blinded outcome assessment aims to evaluate the efficacy and safety of combined pharmacological and mechanical thromboprophylaxis compared to mechanical thromboprophylaxis alone in postoperative patients with CD. A total of 206 patients diagnosed with CD who will be undergoing transsphenoidal surgery will be randomized in a 1:1 ratio to receive either combined pharmacological and mechanical thromboprophylaxis (intervention) or mechanical thromboprophylaxis only (control). The primary outcome is the risk of VTE within 12 weeks following surgery. Discussion This trial represents a significant milestone in evaluating the efficacy of combined pharmacological and mechanical prophylaxis in reducing VTE events in postoperative CD patients. Trial registration ClinicalTrials.gov Identifier: NCT04486859, first registered on 22 July 2020. |
| format | Article |
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| language | English |
| publishDate | 2025-06-01 |
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| spelling | doaj-art-71caeffdcd9943f89cdd55b161675c682025-08-20T02:10:32ZengBMCTrials1745-62152025-06-0126111010.1186/s13063-025-08923-6Postoperative Initiation of Thromboprophylaxis in patients with Cushing’s Disease (PIT-CD): a randomized controlled trialNidan Qiao0Min He1Zhao Ye2Wei Gong3Zengyi Ma4Yifei Yu5Zhenyu Wu6Lin Lu7Huijuan Zhu8Yong Yao9Zhihong Liao10Haijun Wang11Huiwen Tan12Bowen Cai13Yerong Yu14Ting Lei15Yan Yang16Changzhen Jiang17Xiaofang Yan18Yanying Guo19Yuan Chen20Hongying Ye21Yongfei Wang22Nicholas A. Tritos23Zhaoyun Zhang24Yao Zhao25Huashan Hospital, Shanghai Medical College, Fudan University, Department of NeurosurgeryHuashan Hospital, Shanghai Medical College, Fudan University, Department of Endocrinology,Huashan Hospital, Shanghai Medical College, Fudan University, Department of NeurosurgeryHuashan Hospital, Shanghai Medical College, Fudan University, Department of Endocrinology,Huashan Hospital, Shanghai Medical College, Fudan University, Department of NeurosurgeryHuashan Hospital, Shanghai Medical College, Fudan University, Department of Endocrinology,Fudan University, School of Public HealthPeking Union Medical College Hospital, Department of EndocrinologyPeking Union Medical College Hospital, Department of EndocrinologyPeking Union Medical College Hospital, Department of NeurosurgeryThe First Affiliated Hospital, Sun Yat-sen University, Department of EndocrinologyThe First Affiliated Hospital, Sun Yat-sen University, Department of NeurosurgeryChina West Hospital, Department of EndocrinologyChina West Hospital, Department of NeurosurgeryChina West Hospital, Department of EndocrinologyTongji Hospital, Tongji Medical College, Department of NeurosurgeryTongji Hospital, Tongji Medical College, Department of EndocrinologyThe First Affiliated Hospital of Fujian Medical University, Department of NeurosurgeryThe First Affiliated Hospital of Fujian Medical University, Department of EndocrinologyPeople’s Hopital of Xinjiang Uygur Autonomous Region, Department of EndocrinologyPeople’s Hopital of Xinjiang Uygur Autonomous Region, Department of EndocrinologyHuashan Hospital, Shanghai Medical College, Fudan University, Department of Endocrinology,Huashan Hospital, Shanghai Medical College, Fudan University, Department of NeurosurgeryMassachusetts General Hospital and Harvard Medical School, Neuroendocrine UnitHuashan Hospital, Shanghai Medical College, Fudan University, Department of Endocrinology,Huashan Hospital, Shanghai Medical College, Fudan University, Department of NeurosurgeryAbstract Background Pituitary surgical intervention remains the preferred treatment for Cushing’s disease (CD) while postoperative venous thromboembolism (VTE) is a significant risk. Whether to prescribe pharmacological thromboprophylaxis presents a clinical dilemma, balancing the benefit of reducing VTE risk with the potential for increasing hemorrhagic events in these patients. Currently, strong evidence and established protocols for routine pharmacological thromboprophylaxis in this population are lacking. Therefore, a randomized, controlled trial is warranted to determine the efficacy and safety of combined pharmacological and mechanical thromboprophylaxis in reducing postoperative VTE risk in patients with CD. Methods This investigator-initiated, multi-center, prospective, randomized, open-label trial with blinded outcome assessment aims to evaluate the efficacy and safety of combined pharmacological and mechanical thromboprophylaxis compared to mechanical thromboprophylaxis alone in postoperative patients with CD. A total of 206 patients diagnosed with CD who will be undergoing transsphenoidal surgery will be randomized in a 1:1 ratio to receive either combined pharmacological and mechanical thromboprophylaxis (intervention) or mechanical thromboprophylaxis only (control). The primary outcome is the risk of VTE within 12 weeks following surgery. Discussion This trial represents a significant milestone in evaluating the efficacy of combined pharmacological and mechanical prophylaxis in reducing VTE events in postoperative CD patients. Trial registration ClinicalTrials.gov Identifier: NCT04486859, first registered on 22 July 2020.https://doi.org/10.1186/s13063-025-08923-6Pituitary adenomaCushing’s diseaseVenous thromboembolismDeep vein thrombosisPulmonary embolism |
| spellingShingle | Nidan Qiao Min He Zhao Ye Wei Gong Zengyi Ma Yifei Yu Zhenyu Wu Lin Lu Huijuan Zhu Yong Yao Zhihong Liao Haijun Wang Huiwen Tan Bowen Cai Yerong Yu Ting Lei Yan Yang Changzhen Jiang Xiaofang Yan Yanying Guo Yuan Chen Hongying Ye Yongfei Wang Nicholas A. Tritos Zhaoyun Zhang Yao Zhao Postoperative Initiation of Thromboprophylaxis in patients with Cushing’s Disease (PIT-CD): a randomized controlled trial Trials Pituitary adenoma Cushing’s disease Venous thromboembolism Deep vein thrombosis Pulmonary embolism |
| title | Postoperative Initiation of Thromboprophylaxis in patients with Cushing’s Disease (PIT-CD): a randomized controlled trial |
| title_full | Postoperative Initiation of Thromboprophylaxis in patients with Cushing’s Disease (PIT-CD): a randomized controlled trial |
| title_fullStr | Postoperative Initiation of Thromboprophylaxis in patients with Cushing’s Disease (PIT-CD): a randomized controlled trial |
| title_full_unstemmed | Postoperative Initiation of Thromboprophylaxis in patients with Cushing’s Disease (PIT-CD): a randomized controlled trial |
| title_short | Postoperative Initiation of Thromboprophylaxis in patients with Cushing’s Disease (PIT-CD): a randomized controlled trial |
| title_sort | postoperative initiation of thromboprophylaxis in patients with cushing s disease pit cd a randomized controlled trial |
| topic | Pituitary adenoma Cushing’s disease Venous thromboembolism Deep vein thrombosis Pulmonary embolism |
| url | https://doi.org/10.1186/s13063-025-08923-6 |
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