Postoperative Thrombosis Prevention in Patients With CD

Pulmonary Embolism Clinical Trial

Official title:

A Prospective, Multicenter, Randomized Controlled Study of Postoperative Thrombosis Prevention in Patients With Cushing's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04486859
• Other study ID #: KY2020-794
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• ACTH-Secreting Pituitary Adenoma
• Cushing Disease
• DVT
• Embolism
• Pituitary ACTH Hypersecretion
• Pulmonary Embolism
• Thrombosis

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