Postoperative Thrombosis Prevention in Patients With CD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Multicenter, Randomized Controlled Study of Postoperative Thrombosis Prevention in Patients With Cushing's Disease

Conditions
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DVT, Cushing Disease, Pulmonary Embolism

Intervention / Treatment
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* Drug: LMWH/Rivaroxaban
* Device: IPC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cushing's disease patient diagnosed and treated with transsphenoid surgery at study centers Exclusion Criteria: patients with thrombosis before surgery; patients with cute bacterial endocarditis, thrombocytopenia, active peptic ulcer, with contraindications to Rivaroxaban; patients whose cranial MRA or CTA prompts abnormalities in intracranial blood vessels which may be at risk of intracranial hemorrhage; patients with coagulation abnormalities suggesting a high risk of bleeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: mechanical prevention<br>patients were managed with IPC | Device: IPC<br>* mechanical prevention<br>|
| Other: mechanical plus anticoagulant drugs prevention<br>patients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery | Drug: LMWH/Rivaroxaban<br>* combined prevention<br>Device: IPC<br>* mechanical prevention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VTE incidence rate | DVT and PE incidence in 12 weeks after surgery | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |