Cushing Disease, DVT, Pulmonary Embolism
Conditions
Brief summary
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
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.
Interventions
DRUGLMWH/Rivaroxaban
combined prevention
DEVICEIPC
mechanical prevention
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Cushing's disease diagnosed and treated with transsphenoid surgery at study centers
Exclusion criteria
1. History of VTE before surgery or within 24 hours post-surgery 2. Acute bacterial endocarditis 3. Major bleeding events 4. Thrombocytopenia 5. Active gastrointestinal ulcers 6. History of stroke 7. High risk of bleeding due to clotting abnormalities 8. Participation in other clinical trials within the last three months 9. Contraindications to rivaroxaban (e.g., renal dysfunction with eGFR < 50 mL/min) 10. Presence of other malignant diseases 11. Severe mental or neurological disorders 12. Presence of intracranial vascular abnormalities 13. Contraindications to mechanical prophylactic anticoagulation 14. Pregnancy 15. Any other condition that researchers deem inappropriate for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VTE incidence rate | 12 weeks | DVT and PE incidence in 12 weeks after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DVT incidence rate | 12 weeks | DVT in 12 weeks after surgery |
| PE incidence rate | 12 weeks | PE in 12 weeks after surgery |
| Mortality | 12 weeks | All-cause Mortality and VTE-specific Mortality |
| Symptomatic VTE incidence rate | 12 weeks | Symptomatic DVT and PE incidence in 12 weeks after surgery |
Countries
China
Outcome results
None listed