Postoperative Thrombosis Prevention in Patients With CD

N/AActive Not RecruitingNCT04486859

Huashan Hospital206 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

206

Conditions

Cushing Disease DVT Pulmonary Embolism

Interventions

LMWH/RivaroxabanDRUG

combined prevention

IPCDEVICE

mechanical prevention

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (7)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

The First Affiliated Hospital of Sun Yat sen University

Guangzhou, Guangdong, China

Tongji Hospital

Wuhan, Hubei, China

Huashan Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

VTE incidence rate

DVT and PE incidence in 12 weeks after surgery

Time frame: 12 weeks

Secondary Outcomes

DVT incidence rate

DVT in 12 weeks after surgery

Time frame: 12 weeks

PE incidence rate

PE in 12 weeks after surgery

Time frame: 12 weeks

Mortality

All-cause Mortality and VTE-specific Mortality

Time frame: 12 weeks

Symptomatic VTE incidence rate

Symptomatic DVT and PE incidence in 12 weeks after surgery

Time frame: 12 weeks

Data from ClinicalTrials.gov

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