Postoperative Thrombosis Prevention in Patients With CD
Primary Purpose
Cushing Disease, DVT, Pulmonary Embolism
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LMWH/Rivaroxaban
IPC
Sponsored by
About this trial
This is an interventional prevention trial for Cushing Disease
Eligibility Criteria
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
Sites / Locations
- The First Affiliated Hospital of Sun Yat sen UniversityRecruiting
- Tongji HospitalRecruiting
- Huashan HospitalRecruiting
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
mechanical prevention
mechanical plus anticoagulant drugs prevention
Arm Description
patients were managed with IPC
patients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery
Outcomes
Primary Outcome Measures
VTE incidence rate
DVT and PE incidence in 12 weeks after surgery
Secondary Outcome Measures
DVT incidence rate
DVT in 12 weeks after surgery
PE incidence rate
PE in 12 weeks after surgery
Mortality
All-cause Mortality and VTE-specific Mortality
Symptomatic VTE incidence rate
Symptomatic DVT and PE incidence in 12 weeks after surgery
Full Information
NCT ID
NCT04486859
First Posted
July 22, 2020
Last Updated
July 10, 2022
Sponsor
Huashan Hospital
Collaborators
Peking Union Medical College Hospital, West China Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04486859
Brief Title
Postoperative Thrombosis Prevention in Patients With CD
Official Title
A Prospective, Multicenter, Randomized Controlled Study of Postoperative Thrombosis Prevention in Patients With Cushing's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
Collaborators
Peking Union Medical College Hospital, West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing Disease, DVT, Pulmonary Embolism
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
206 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mechanical prevention
Arm Type
Other
Arm Description
patients were managed with IPC
Arm Title
mechanical plus anticoagulant drugs prevention
Arm Type
Other
Arm Description
patients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery
Intervention Type
Drug
Intervention Name(s)
LMWH/Rivaroxaban
Intervention Description
combined prevention
Intervention Type
Device
Intervention Name(s)
IPC
Intervention Description
mechanical prevention
Primary Outcome Measure Information:
Title
VTE incidence rate
Description
DVT and PE incidence in 12 weeks after surgery
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
DVT incidence rate
Description
DVT in 12 weeks after surgery
Time Frame
12 weeks
Title
PE incidence rate
Description
PE in 12 weeks after surgery
Time Frame
12 weeks
Title
Mortality
Description
All-cause Mortality and VTE-specific Mortality
Time Frame
12 weeks
Title
Symptomatic VTE incidence rate
Description
Symptomatic DVT and PE incidence in 12 weeks after surgery
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haijun Wang
Phone
020-87755766
Email
XXX@sysu.edu.cn
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Chen
Phone
027-83665555
Email
XXX@mail.hust.edu.cn
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao Zhao
Phone
86-13916872553
Email
zhaoyaohs@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Yao Zhao
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huijuan Zhu
Phone
010-69156114
Email
XXX@pumch.edu
12. IPD Sharing Statement
Learn more about this trial
Postoperative Thrombosis Prevention in Patients With CD
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