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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04486859
Other study ID # KY2020-794
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date July 31, 2023

Study information

Verified date July 2022
Source Huashan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 206
Est. completion date July 31, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Intervention

Drug:
LMWH/Rivaroxaban
combined prevention
Device:
IPC
mechanical prevention

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing
China The First Affiliated Hospital of Sun Yat sen University Guangzhou Guangdong
China Huashan Hospital Shanghai Shanghai
China Tongji Hospital Wuhan Hubei

Sponsors (3)

Lead Sponsor Collaborator
Huashan Hospital Peking Union Medical College Hospital, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary VTE incidence rate DVT and PE incidence in 12 weeks after surgery 12 weeks
Secondary DVT incidence rate DVT in 12 weeks after surgery 12 weeks
Secondary PE incidence rate PE in 12 weeks after surgery 12 weeks
Secondary Mortality All-cause Mortality and VTE-specific Mortality 12 weeks
Secondary Symptomatic VTE incidence rate Symptomatic DVT and PE incidence in 12 weeks after surgery 12 weeks
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