Management of Anticoagulants and Antithrombotics in Patients With CSDH
Recruiting
- Conditions
- Anticoagulant-induced BleedingCardiovascular StrokeChronic Subdural HematomaThromboembolic Stroke
- Interventions
- Procedure: CSDH evacuation
- Registration Number
- NCT05079295
- Lead Sponsor
- University Hospital of Ferrara
- Brief Summary
Primary objective of the study will be to compare, up to 6 months after surgery, number of relapses (post operative re-bleeding) or intracerebral hemorrhage (others than subdural hematomas) and thromboembolic or cardiovascular ischemic events, in patients undergoing surgery for chronic subdural hematoma (CSDH). These data will be correlated to the suspension or not of antithrombotics or anticoagulants before surgery or their re-introduction after surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- Age > 18 years old
- Informed consent
- Evidence of CSDH which needs surgery
- patients taking antithrombotics or anticoagulants
Exclusion Criteria
- previous surgery for CSDH
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 CSDH evacuation Patients taking anticoagulants or antithrombotics Group 2 CSDH evacuation Controls
- Primary Outcome Measures
Name Time Method hemorrhagic or thromboembolic events evaluation up to 6 months after surgery hemorrhagic (re-bleedings in surgical field, other cerebral bleedings); thromboembolic events(acute ischemic stroke, acute myocardial infarction, pulmunoray embolism, deep venous thrombosis)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Sant'Anna
🇮🇹Ferrara, Emilia-Romagna, Italy