Management of Anticoagulants and Antithrombotics in Patients With CSDH

NCT ID: NCT05079295

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-20

Study Completion Date

2024-02-20

Brief Summary

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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

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Conditions

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Chronic Subdural Hematoma Anticoagulant-induced Bleeding Thromboembolic Stroke Cardiovascular Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients taking anticoagulants or antithrombotics

CSDH evacuation

Intervention Type PROCEDURE

Burr hole for chronic subdural hematomas

Group 2

Controls

CSDH evacuation

Intervention Type PROCEDURE

Burr hole for chronic subdural hematomas

Interventions

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CSDH evacuation

Burr hole for chronic subdural hematomas

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Dott.ssa Alba Scerrati

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Sant'Anna

Ferrara, Emilia-Romagna, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Alba Scerrati, MD

Role: primary

+39532236292

Other Identifiers

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1102/2020/Oss/AOUFe

Identifier Type: -

Identifier Source: org_study_id

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