Postoperative Thrombosis Prevention in Patients With CD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2025-07-01

Brief Summary

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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.

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Detailed Description

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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

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Cushing Disease DVT Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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mechanical prevention

patients were managed with IPC

Group Type OTHER

IPC

Intervention Type DEVICE

mechanical prevention

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

Group Type OTHER

LMWH/Rivaroxaban

Intervention Type DRUG

combined prevention

IPC

Intervention Type DEVICE

mechanical prevention

Interventions

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LMWH/Rivaroxaban

combined prevention

Intervention Type DRUG

IPC

mechanical prevention

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No