Cushing DiseasePIT-CDNCT04486859
Postoperative Thrombosis Prevention in Patients With CD
A study testing LMWH/Rivaroxaban and IPC in people with Cushing Disease and DVT, run by Huashan Hospital at 7 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cushing Disease, DVT, Pulmonary Embolism
- What is being tested?
- LMWH/Rivaroxaban and IPC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 7 sitesChina
- Study dates
- 1 Dec 2020to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cushing\'s disease diagnosed and treated with transsphenoid surgery at study centers
Who cannot join
- History of VTE before surgery or within 24 hours post-surgery
- Acute bacterial endocarditis
- Major bleeding events
- Thrombocytopenia
- Active gastrointestinal ulcers
- History of stroke
Show all 15Show fewer
- High risk of bleeding due to clotting abnormalities
- Participation in other clinical trials within the last three months
- Contraindications to rivaroxaban (e.g., renal dysfunction with eGFR \< 50 mL/min)
- Presence of other malignant diseases
- Severe mental or neurological disorders
- Presence of intracranial vascular abnormalities
- Contraindications to mechanical prophylactic anticoagulation
- Pregnancy
- Any other condition that researchers deem inappropriate for study participation.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking Union Medical College Hospital
Beijing
China West Hospital
Chengdu, Sichuan, 610041
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350004
The First Affiliated Hospital of Sun Yat sen University
Guangzhou, Guangdong, 510000
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
People's Hopital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001
Tongji Hospital
Wuhan, Hubei, 430000
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Study of Postoperative Initiation of Thromboprophylaxis 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.
Read the 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.
- Conditions
- Cushing Disease, DVT, Pulmonary Embolism
- Being tested
- LMWH/Rivaroxaban, IPC
- Medical subject headings
- Pituitary ACTH Hypersecretion, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMWH/RivaroxabanDrug
combined prevention
IPCDevice
mechanical prevention
| Study group | Role | What they receive |
|---|---|---|
| mechanical prevention | Other | patients were managed with IPC Receives: Device: IPC |
| mechanical plus anticoagulant drugs prevention | Other | patients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery Receives: Drug: LMWH/Rivaroxaban; Device: IPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE incidence rate
DVT and PE incidence in 12 weeks after surgery
Measured: 12 weeks
Secondary outcomes (4)
DVT incidence rate
DVT in 12 weeks after surgery
Measured: 12 weeks
PE incidence rate
PE in 12 weeks after surgery
Measured: 12 weeks
Mortality
All-cause Mortality and VTE-specific Mortality
Measured: 12 weeks
Symptomatic VTE incidence rate
Symptomatic DVT and PE incidence in 12 weeks after surgery
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Dec 2020
- Primary completion1 May 2025
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cushing DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoyun Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486859
- Sponsor's protocol ID
- KY2020-794
- Acronym
- PIT-CD
- Status last verified
- Jun 2025
- First submitted
- 22 Jul 2020
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qiao N, He M, Ye Z, Gong W, Ma Z, Yu Y, Wu Z, Lu L, Zhu H, Yao Y, Liao Z, Wang H, Tan H, Cai B, Yu Y, Lei T, Yang Y, Jiang C, Yan X, Guo Y, Chen Y, Ye H, Wang Y, Tritos NA, Zhang Z, Zhao Y. Postoperative Initiation of Thromboprophylaxis in patients with Cushing's Disease (PIT-CD): a randomized controlled trial. Trials. 2025 Jun 21;26(1):217. doi: 10.1186/s13063-025-08923-6.
PubMed 40544300
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Study of Postoperative Initiation of Thromboprophylaxis in Patients With Cushing's Disease
- ClinicalTrials.gov ID
- NCT04486859
- Acronym / sponsor ID
- PIT-CD / KY2020-794
- Conditions
- Cushing Disease, DVT, Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mechanical prevention | Other | Device: IPCpatients were managed with IPC |
| mechanical plus anticoagulant drugs prevention | Other | Drug: LMWH/Rivaroxaban, Device: IPCpatients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cushing\'s disease diagnosed and treated with transsphenoid surgery at study centers
Key exclusion criteria (15 listed)
- History of VTE before surgery or within 24 hours post-surgery
- Acute bacterial endocarditis
- Major bleeding events
- Thrombocytopenia
- Active gastrointestinal ulcers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMWH/Rivaroxabancombined prevention | Drug | mechanical plus anticoagulant drugs prevention |
| IPCmechanical prevention | Device | mechanical plus anticoagulant drugs prevention, mechanical prevention |
Primary outcome
VTE incidence rate
Time frame: 12 weeks
DVT and PE incidence in 12 weeks after surgery
4 secondary outcomes
DVT incidence rate
Time frame: 12 weeks
PE incidence rate
Time frame: 12 weeks
Mortality
Time frame: 12 weeks
Symptomatic VTE incidence rate
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Derived from this study: PubMed 40544300Qiao N, He M, Ye Z, Gong W, Ma Z, Yu Y, Wu Z, Lu L, Zhu H, Yao Y, Liao Z, Wang H, Tan H, Cai B, Yu Y, Lei T, Yang Y, Jiang C, Yan X, Guo Y, Chen Y, Ye H, Wang Y, Tritos NA, Zhang Z, Zhao Y. Postoperative Initiation of Thromboprophylaxis in patients with Cushing's Disease (PIT-CD): a randomized controlled trial. Trials. 2025 Jun 21;26(1):217. doi: 10.1186/s13063-025-08923-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMWH/Rivaroxaban and IPC in people with Cushing Disease and DVT, run by Huashan Hospital at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VTE incidence rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04486859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.