Postoperative Thrombosis Prevention in Patients With CD

Not Applicable

• Conditions: Pulmonary Embolism; Cushing Disease; DVT
• Interventions: Device: IPC; Drug: LMWH/Rivaroxaban

• Registration Number: NCT04486859
• Lead Sponsor: Huashan Hospital

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.

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Study Start: 2020-12-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-10
• Last Update Posted: 2022-07-12
• Primary Completion: 2023-01-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 206

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mechanical prevention	IPC	patients were managed with IPC
mechanical plus anticoagulant drugs prevention	LMWH/Rivaroxaban	patients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery
mechanical plus anticoagulant drugs prevention	IPC	patients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery

Primary Outcome Measures

Name	Time	Method
VTE incidence rate	12 weeks	DVT and PE incidence in 12 weeks after surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

China West Hospital; 🇨🇳 Chengdu, Sichuan, China

People's Hopital of Xinjiang Uygur Autonomous Region; 🇨🇳 Urumqi, Xinjiang, China

The First Affiliated Hospital of Sun Yat sen University; 🇨🇳 Guangzhou, Guangdong, China

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China