Postoperative Thrombosis Prevention in Patients With CD (PIT-CD)

Fudan University

Status: Active, not recruiting

Conditions: Pulmonary Embolism; Cushing Disease; DVT

Treatments: Drug: LMWH/Rivaroxaban; Device: IPC

Study type: Interventional

Funder types: Other

Identifiers

NCT04486859

KY2020-794

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

206 participants in 2 patient groups

mechanical prevention

Other group

Description:

patients were managed with IPC

Treatment:

Device: IPC

mechanical plus anticoagulant drugs prevention

Other group

Description:

patients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery

Treatment:

Device: IPC

Drug: LMWH/Rivaroxaban