NCT04486859

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

4.4 years

First QC Date

July 22, 2020

Last Update Submit

June 29, 2025

Conditions

Cushing DiseaseDVTPulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • VTE incidence rate

    DVT and PE incidence in 12 weeks after surgery

    12 weeks

Secondary Outcomes (4)

  • DVT incidence rate

    12 weeks

  • PE incidence rate

    12 weeks

  • Mortality

    12 weeks

  • Symptomatic VTE incidence rate

    12 weeks

Study Arms (2)

mechanical prevention

OTHER

patients were managed with IPC

Device: IPC

mechanical plus anticoagulant drugs prevention

OTHER

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

Drug: LMWH/RivaroxabanDevice: IPC

Interventions

LMWH/RivaroxabanDRUG

combined prevention

mechanical plus anticoagulant drugs prevention
IPCDEVICE

mechanical prevention

mechanical plus anticoagulant drugs preventionmechanical prevention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004, China

Location

The First Affiliated Hospital of Sun Yat sen University

Guangzhou, Guangdong, 510000, China

Location

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

China West Hospital

Chengdu, Sichuan, 610041, China

Location

People's Hopital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830001, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Related Publications (1)

  • Qiao N, He M, Ye Z, Gong W, Ma Z, Yu Y, Wu Z, Lu L, Zhu H, Yao Y, Liao Z, Wang H, Tan H, Cai B, Yu Y, Lei T, Yang Y, Jiang C, Yan X, Guo Y, Chen Y, Ye H, Wang Y, Tritos NA, Zhang Z, Zhao Y. Postoperative Initiation of Thromboprophylaxis in patients with Cushing's Disease (PIT-CD): a randomized controlled trial. Trials. 2025 Jun 21;26(1):217. doi: 10.1186/s13063-025-08923-6.

    PMID: 40544300DERIVED

MeSH Terms

Conditions

Pituitary ACTH HypersecretionPulmonary Embolism

Condition Hierarchy (Ancestors)

HyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice director of endocrine department

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 27, 2020

Study Start

December 1, 2020

Primary Completion

May 1, 2025

Study Completion

July 1, 2025

Last Updated

July 2, 2025

Record last verified: 2025-06

Locations

CN(7)