Management of Anticoagulants and Antithrombotics in Patie... | NCT05079295

Studies
Management of Anticoagulants and Antithrombotics in Patients With CSDH

NCT05079295

Sponsor

University Hospital of Ferrara

Status

Unknown status

Last Update Posted

Nov 3, 2022Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Chronic Subdural Hematoma
Anticoagulant-induced Bleeding
Thromboembolic Stroke
Cardiovascular Stroke

Interventions

CSDH evacuation

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2021Actual

Primary Completion Date

Feb 20, 2023Estimated

Completion Date

Feb 20, 2024Estimated

First Submitted Date

Oct 3, 2021

First Submission Date that Met QC Criteria

Oct 3, 2021

First Posted Date

Oct 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2022

Last Update Posted Date

Nov 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dott.ssa Alba Scerrati, Principal Investigator, University Hospital of FerraraPrincipal Investigator

Lead Sponsor

University Hospital of FerraraOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Patients taking anticoagulants or antithrombotics	Procedure: CSDH evacuation
Group 2		Controls	Procedure: CSDH evacuation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CSDH evacuation	Procedure	Burr hole for chronic subdural hematomas	Group 1 Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

All patients suffering from CSDH which needs surgery for its evacuation. Study group will be all patients taking anticoagulants or antithrombotics; control group will be all patients who are not taking these drugs.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Sant'Anna	Recruiting	Ferrara	Emilia-Romagna	44124	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020200	Hematoma, Subdural, Chronic
D009203	Myocardial Infarction
D013923	Thromboembolism

Ancestor Terms

ID	Term
D006408	Hematoma, Subdural
D020198	Intracranial Hemorrhage, Traumatic
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders

Browse Leaves

Not provided

Browse Branches

Not provided