Postoperative Thrombosis Prevention in Patients With CD

July 10, 2022 updated by: Zhaoyun Zhang, Huashan Hospital

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

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.

Study Overview

Status

Recruiting

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 Type

Interventional

Enrollment (Anticipated)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Sun Yat sen University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Tongji Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: mechanical prevention
patients were managed with IPC
mechanical prevention
OTHER: mechanical plus anticoagulant drugs prevention
patients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery
mechanical prevention
combined prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VTE incidence rate
Time Frame: 12 weeks
DVT and PE incidence in 12 weeks after surgery
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DVT incidence rate
Time Frame: 12 weeks
DVT in 12 weeks after surgery
12 weeks
PE incidence rate
Time Frame: 12 weeks
PE in 12 weeks after surgery
12 weeks
Mortality
Time Frame: 12 weeks
All-cause Mortality and VTE-specific Mortality
12 weeks
Symptomatic VTE incidence rate
Time Frame: 12 weeks
Symptomatic DVT and PE incidence in 12 weeks after surgery
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2020

Primary Completion (ANTICIPATED)

January 31, 2023

Study Completion (ANTICIPATED)

July 31, 2023

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (ACTUAL)

July 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 10, 2022

Last Verified

July 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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