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Active, Not Recruiting

NCT Number: NCT04486859

Postoperative Thrombosis Prevention in Patients With CD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cushing Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases DVT Embolism Embolism and Thrombosis Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Lung Diseases Nervous System Diseases Pituitary ACTH Hypersecretion Pituitary Diseases Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of VTE before surgery or within 24 hours post-surgery
  • Acute bacterial endocarditis
  • Major bleeding events
  • Thrombocytopenia
  • Active gastrointestinal ulcers
  • History of stroke
  • High risk of bleeding due to clotting abnormalities
  • Participation in other clinical trials within the last three months
  • Contraindications to rivaroxaban (e.g., renal dysfunction with eGFR < 50 mL/min)
  • Presence of other malignant diseases
  • Severe mental or neurological disorders
  • Presence of intracranial vascular abnormalities
  • Contraindications to mechanical prophylactic anticoagulation
  • Pregnancy
  • Any other condition that researchers deem inappropriate for study participation.

Treatment and study plan

LMWH/Rivaroxaban

Drug

combined prevention

IPC

Device

mechanical prevention

Primary outcomes

  1. VTE incidence rate

    Time frame: 12 weeks

    DVT and PE incidence in 12 weeks after surgery

Secondary outcomes

  1. DVT incidence rate

    Time frame: 12 weeks

    DVT in 12 weeks after surgery

  2. PE incidence rate

    Time frame: 12 weeks

    PE in 12 weeks after surgery

  3. Mortality

    Time frame: 12 weeks

    All-cause Mortality and VTE-specific Mortality

  4. Symptomatic VTE incidence rate

    Time frame: 12 weeks

    Symptomatic DVT and PE incidence in 12 weeks after surgery

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

A Prospective, Multicenter, Randomized Controlled Study of Postoperative Initiation of Thromboprophylaxis in Patients With Cushing's Disease

Acronym: PIT-CD

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jul 27, 2020
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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