Postoperative Thrombosis Prevention in Patients With CD

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    206
  • sponsor
    Huashan Hospital
Updated on 27 July 2022
thrombosis
clot
rivaroxaban
lmwh
postoperative thrombosis

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.

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.

Details
Condition Cushing Disease, DVT, Pulmonary Embolism
Treatment LMWH/Rivaroxaban, IPC
Clinical Study IdentifierNCT04486859
SponsorHuashan Hospital
Last Modified on27 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

patients with thrombosis before surgery
patients with cute bacterial endocarditis
thrombocytopenia
active peptic ulcer
with contraindications to Rivaroxaban
patients whose cranial MRA or CTA prompts abnormalities in intracranial blood vessels which may be at risk of intracranial hemorrhage
patients with coagulation abnormalities suggesting a high risk of bleeding
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