Clinical trial NCT04486859: Postoperative Thrombosis Prevention in Patients With CD
Official title: A Prospective, Multicenter, Randomized Controlled Study of Postoperative Initiation of Thromboprophylaxis in Patients With Cushing's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cushing Disease
DVT
Pulmonary Embolism
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Cushing\&#39;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 \&lt; 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.

Primary outcomes:
measure: VTE incidence rate
timeFrame: 12 weeks
Secondary outcomes:
measure: DVT incidence rate
timeFrame: 12 weeks
measure: PE incidence rate
timeFrame: 12 weeks
measure: Mortality
timeFrame: 12 weeks
measure: Symptomatic VTE incidence rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat sen University
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
city: Chengdu
country: China
facility: China West Hospital
state: Sichuan
city: Urumqi
country: China
facility: People's Hopital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References: