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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
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cushing Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 22, 2020
Last Updated
July 10, 2022
Sponsor
Huashan Hospital
Collaborators
Peking Union Medical College Hospital, West China Hospital
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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

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Postoperative Thrombosis Prevention in Patients With CD

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