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Active, not recruitingNCT04486859PIT-CDUpdated Jul 2, 2025

Postoperative Thrombosis Prevention in Patients With CD

An interventional study of LMWH/Rivaroxaban and IPC in Cushing Disease, DVT and Pulmonary Embolism, sponsored by Huashan Hospital. Active, not recruiting at 7 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-02.

Sponsored by Huashan Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cushing Disease
  • DVT
  • Pulmonary Embolism
03

In context

Pituitary ACTH Hypersecretion

64 studies on the registry are indexed under Pituitary ACTH Hypersecretion; 16 are open to participants now.

This study's planned enrollment of 206 is above the median of 44 across 40 interventional studies indexed under Pituitary ACTH Hypersecretion.

Browse Pituitary ACTH Hypersecretion studies →

Lead sponsor

Huashan Hospital is the lead sponsor of 247 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Cushing\'s disease diagnosed and treated with transsphenoid surgery at study centers

Exclusion criteria

Exclusion Criteria:

  1. History of VTE before surgery or within 24 hours post-surgery
  2. Acute bacterial endocarditis
  3. Major bleeding events
  4. Thrombocytopenia
  5. Active gastrointestinal ulcers
  6. History of stroke
  7. High risk of bleeding due to clotting abnormalities
  8. Participation in other clinical trials within the last three months
  9. to rivaroxaban (e.g., renal dysfunction with \< 50 mL/min)
  10. Presence of other malignant diseases
  11. Severe mental or neurological disorders
  12. Presence of intracranial vascular abnormalities
  13. Contraindications to mechanical prophylactic anticoagulation
  14. Pregnancy
  15. Any other condition that researchers deem inappropriate for study participation.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
206 participants (estimated)

Study arms

  • Other
    mechanical prevention

    patients were managed with IPC

    Device: IPC

  • 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

    Drug: LMWH/Rivaroxaban · Device: IPC

Interventions

06

What researchers measure

Primary outcomes

  1. VTE incidence rate

    DVT and PE incidence in 12 weeks after surgery

    Time frame: 12 weeks

Secondary outcomes

  1. DVT incidence rate

    DVT in 12 weeks after surgery

    Time frame: 12 weeks

  2. PE incidence rate

    PE in 12 weeks after surgery

    Time frame: 12 weeks

  3. Mortality

    All-cause Mortality and VTE-specific Mortality

    Time frame: 12 weeks

  4. Symptomatic VTE incidence rate

    Symptomatic DVT and PE incidence in 12 weeks after surgery

    Time frame: 12 weeks

07

Study locations

7 sites
08

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2020 to primary completion in May 2025, 53 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2020
First posted
Jul 27, 2020
StartActual
Dec 1, 2020
Primary completionActual
May 1, 2025
CompletionEst.
Jul 1, 2025
Last update
Jul 2, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04486859
Lead sponsor
Huashan Hospital
Responsible party
Zhaoyun Zhang (vice director of endocrine department, Huashan Hospital) — Principal investigator
First posted
Jul 27, 2020
Start date
Dec 1, 2020
Primary completion
May 1, 2025
Completion
Jul 1, 2025 (estimated)
Last update
Jul 2, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Heparin, Low-Molecular-Weight · Rivaroxaban

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