Postoperative Thrombosis Prevention in Patients With CD

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04486859
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Huashan Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cushing Disease, DVT, Pulmonary Embolism
Additional Details

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.

Arms & Interventions

Arms

Other: mechanical prevention

patients were managed with IPC

Other: 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

Interventions

Drug: - LMWH/Rivaroxaban

combined prevention

Device: - IPC

mechanical prevention

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Fuzhou, Fujian, China

Status

Recruiting

Address

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004

Site Contact

Zhiliang Wang

[email protected]

0591-87983333

Guangzhou, Guangdong, China

Status

Recruiting

Address

The First Affiliated Hospital of Sun Yat sen University

Guangzhou, Guangdong, 510000

Site Contact

Shaolin Zhang

[email protected]

020-87755766

Tongji Hospital, Wuhan, Hubei, China

Status

Recruiting

Address

Tongji Hospital

Wuhan, Hubei, 430000

Site Contact

Juan Chen

[email protected]

027-83665555

Huashan Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Huashan Hospital

Shanghai, Shanghai, 200040

Site Contact

Yao Zhao

[email protected]

86-13916872553

China West Hospital, Chengdu, Sichuan, China

Status

Recruiting

Address

China West Hospital

Chengdu, Sichuan, 610041

Site Contact

Yu Tang

[email protected]

028-85422114

Urumqi, Xinjiang, China

Status

Recruiting

Address

People's Hopital of Xinjiang Uygur Autonomous Region

Urumqi, Xinjiang, 830001

Site Contact

Yuan Chen

[email protected]

0991-8562209

Peking Union Medical College Hospital, Beijing, China

Status

Recruiting

Address

Peking Union Medical College Hospital

Beijing, ,

Site Contact

Liyuan Zhang

[email protected]

010-69156114

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