Preventing blood clots after surgery in patients with Cushing disease
A Prospective, Multicenter, Randomized Controlled Study of Postoperative Initiation of Thromboprophylaxis in Patients With Cushing's Disease
This study is testing whether a combination of blood-thinning medications and mechanical methods can help prevent blood clots in patients with Cushing disease after they have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 206 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 7 sites (Fuzhou, Fujian and 6 other locations) |
| Trial ID | NCT04486859 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of anticoagulant drugs combined with mechanical prevention methods in preventing postoperative venous thrombosis (VTE) in patients with Cushing disease following transsphenoidal surgery. Patients are randomized into two groups: one receiving mechanical prevention alone and the other receiving mechanical prevention plus low molecular weight heparin (LMWH) followed by rivaroxaban. The study monitors the occurrence of VTE and bleeding events at various intervals post-surgery. The goal is to establish a consensus on effective anticoagulation protocols for this high-risk patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with Cushing's disease who are undergoing transsphenoidal surgery.
Not a fit: Patients with a history of venous thromboembolism or those with contraindications to anticoagulation therapies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of life-threatening blood clots in patients recovering from surgery for Cushing disease.
How similar studies have performed: While there is limited data on randomized studies specifically for Cushing disease, similar approaches in postoperative VTE prevention have shown promise in other surgical populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cushing\'s disease diagnosed and treated with transsphenoid surgery at study centers 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. Contraindications to rivaroxaban (e.g., renal dysfunction with eGFR \< 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.
Where this trial is running
Fuzhou, Fujian and 6 other locations
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
- The First Affiliated Hospital of Sun Yat sen University — Guangzhou, Guangdong, China (Recruiting)
- Tongji Hospital — Wuhan, Hubei, China (Recruiting)
- Huashan Hospital — Shanghai, Shanghai, China (Recruiting)
- China West Hospital — Chengdu, Sichuan, China (Recruiting)
- People's Hopital of Xinjiang Uygur Autonomous Region — Urumqi, Xinjiang, China (Recruiting)
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.