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Clinical study on efficacy and safety of prophylactic anticoagulation after middle ear surgery under general anesthesia

Clinical study on efficacy and safety of prophylactic anticoagulation after middle ear surgery under general anesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089251
Enrollment
Unknown
Registered
2024-09-04
Start date
2024-09-05
Completion date
Unknown
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

otitis media

Interventions

intervention group:Rivaroxaban 10mg qd orally was administered 6-10 hours after surgery and discontinued on the 7th day after surgery
control group:No anticoagulation treatment

Sponsors

Beijing Tsinghua Changgung Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Middle ear surgery under general anesthesia for patients with ear diseases =40 years old and =80 years old; Operation duration =2 hours.

Exclusion criteria

Exclusion criteria: 1) Patients with venous thrombosis and elevated D-Dimer found by preoperative examination after admission; 2) Patients undergoing anticoagulation or antiplatelet therapy at admission; 3) Risk assessment table for anticoagulant bleeding (HAS-BLED=3); 4) Patients known to be allergic to rivaroxaban; 5) Acute or chronic kidney disease (glomerular filtration rate less than 30ml/min); 6) Life expectancy is not more than 6 months or it is expected to be difficult to complete the interview

Design outcomes

Primary

MeasureTime frame
Incidence of lower extremity venous thrombosis or pulmonary embolism 1 week after surgery;

Countries

China

Contacts

Public ContactYi Haijin

Beijing Tsinghua Changgung Hospital

Dl7599@163.com+86 186 0103 2722

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026