- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04486859
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
Conditions
Intervention / Treatment
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:
- Huijuan Zhu
- Phone Number: 010-69156114
- Email: XXX@pumch.edu
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- The First Affiliated Hospital of Sun Yat sen University
-
Contact:
- Haijun Wang
- Phone Number: 020-87755766
- Email: XXX@sysu.edu.cn
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Recruiting
- Tongji Hospital
-
Contact:
- Juan Chen
- Phone Number: 027-83665555
- Email: XXX@mail.hust.edu.cn
-
-
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Embolism and Thrombosis
- Hypothalamic Diseases
- Hyperpituitarism
- Pituitary Diseases
- Adenoma
- Pituitary Neoplasms
- Embolism
- Thrombosis
- Pulmonary Embolism
- ACTH-Secreting Pituitary Adenoma
- Pituitary ACTH Hypersecretion
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Rivaroxaban
Other Study ID Numbers
- KY2020-794
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Pulmonary Embolism
-
Boston Scientific CorporationEKOS CorporationCompletedPulmonary Embolism | Acute Pulmonary Embolism | Pulmonary Thromboembolism | Massive Pulmonary Embolism | Sub-massive Pulmonary EmbolismUnited States
-
Inari MedicalCompletedPulmonary Embolism | Submassive Pulmonary Embolism | Acute Pulmonary Embolism | Massive Pulmonary EmbolismUnited States
-
University of California, Los AngelesEnrolling by invitationPulmonary Disease | Pulmonary Embolism | Pulmonary Embolus/Emboli | Pulmonary Embolism and Thrombosis | Pulmonary Embolism Subacute Massive | Pulmonary Embolism Acute MassiveUnited States
-
Bristol-Myers SquibbCompletedPulmonary Embolism (PE) | Pulmonary ThromboembolismUnited Kingdom
-
Inari MedicalActive, not recruitingPE - Pulmonary Embolism | PE - Pulmonary ThromboembolismUnited States, Spain, Belgium, Germany, France, Switzerland, Netherlands, United Kingdom, Austria
-
GlaxoSmithKlineCompleted
-
Sociedad Española de Neumología y Cirugía TorácicaCompletedPulmonary Hypertension | Pulmonary ThromboembolismsSpain
-
Victor Tapson, MDBristol-Myers SquibbTerminatedPulmonary Embolism | Right Ventricular Dysfunction | Right Ventricular Failure | Pulmonary Embolism With Acute Cor Pulmonale | Pulmonary Embolism With Pulmonary Infarction | Pulmonary Embolism Subacute MassiveUnited States
-
Imperative Care, Inc.RecruitingCardiovascular Diseases | Vascular Diseases | Embolism | Thrombosis | Thromboembolism | Acute Pulmonary Embolism | Thrombus; Embolism | Emboli, PulmonaryUnited States
-
Suzhou Zenith Vascular Scitech Co., Ltd.Not yet recruitingPE - Pulmonary Embolism | PE - Pulmonary ThromboembolismChina
Clinical Trials on IPC
-
University of ValenciaRecruiting
-
Johns Hopkins UniversityMedical University of South Carolina; Vanderbilt University Medical Center; University... and other collaboratorsRecruitingPleural EffusionUnited States, United Kingdom
-
Peking University Third HospitalCompletedAcute Myocardial InfarctionChina
-
Radboud University Medical CenterCompletedCardiovascular DiseaseNetherlands
-
Institut Paoli-CalmettesNot yet recruitingBreast Cancer | Colorectal Cancer | Lung CancerFrance
-
Karolinska University HospitalIstituto Ortopedico Rizzoli; Sahlgrenska University Hospital, Sweden; University... and other collaboratorsRecruitingVenous Thromboembolism | Ankle Fractures | Achilles Tendon RuptureSweden
-
M.D. Anderson Cancer CenterCareFusionActive, not recruitingAdvanced Cancer | Pleural EffusionUnited States
-
University of PennsylvaniaOsciFlex LLCCompletedDeep Vein Thrombosis | Venous Thromboembolism | Pulmonary ThromboembolismsUnited States
-
National University of SingaporeSaglik Bilimleri UniversitesiRecruitingHospital-acquired InfectionsCambodia