Management of Anticoagulants and Antithrombotics in Patients With CSDH

NCT05079295 | Unknown FDA Drug

• 1 other identifier: 1102/2020/Oss/AOUFe
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Subdural Hematoma; Anticoagulant-induced Bleeding; Thromboembolic Stroke; Cardiovascular Stroke

Keywords

chronic subdural hematoma; anticoagulants; antithrombotics; thromboembolic disease; cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

Patients taking anticoagulants or antithrombotics

Procedure: CSDH evacuation

Group 2

Controls

Procedure: CSDH evacuation

Interventions

CSDH evacuation PROCEDURE

Burr hole for chronic subdural hematomas

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Age \> 18 years old
• Informed consent
• Evidence of CSDH which needs surgery
• patients taking antithrombotics or anticoagulants

You may not qualify if:

• previous surgery for CSDH

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

University Hospital Sant'Anna

Ferrara, Emilia-Romagna, 44124, Italy

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Myocardial Infarction; Thromboembolism

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Necrosis; Embolism and Thrombosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2021
• First Posted: October 15, 2021
• Study Start: February 20, 2021
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2024
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

IT (1)