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NCT05079295 Clinical Trial

Management of Anticoagulants and Antithrombotics in Patients With CSDH

Chronic Subdural Hematoma Clinical Trial

— THERCA  

Official title:
Thromboembolic and Hemorrhagic Risk Evaluation in Surgically Treated Patients With CSDH Taking Anticoagulants and Antithrombotics

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05079295
Other study ID # 1102/2020/Oss/AOUFe
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 20, 2021
Est. completion date February 20, 2024

Study information
Verified date November 2022
Source University Hospital of Ferrara
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date February 20, 2024
Est. primary completion date February 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• CSDH evacuation
Burr hole for chronic subdural hematomas

Locations
Country Name City State
Italy University Hospital Sant'Anna Ferrara Emilia-Romagna

Sponsors (1)
Lead Sponsor Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary hemorrhagic or thromboembolic events evaluation hemorrhagic (re-bleedings in surgical field, other cerebral bleedings); thromboembolic events(acute ischemic stroke, acute myocardial infarction, pulmunoray embolism, deep venous thrombosis) up to 6 months after surgery
See also
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Completed NCT03447327 - Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma N/A
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Recruiting NCT05267184 - Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma N/A
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