Management of Anticoagulants and Antithrombotics in Patients With CSDH (THERCA)

November 2, 2022 updated by: Dott.ssa Alba Scerrati, University Hospital of Ferrara

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italy, 44124
        • Recruiting
        • University Hospital Sant'Anna
        • Contact:
        • Sub-Investigator:
          • Pasquale De Bonis, Prof
        • Sub-Investigator:
          • Giorgio Mantovani, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 2
Controls
Procedure: CSDH evacuation
Burr hole for chronic subdural hematomas
Group 1
Patients taking anticoagulants or antithrombotics
Procedure: CSDH evacuation
Burr hole for chronic subdural hematomas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemorrhagic or thromboembolic events evaluation
Time Frame: 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)
up to 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2021

Primary Completion (Anticipated)

February 20, 2023

Study Completion (Anticipated)

February 20, 2024

Study Registration Dates

First Submitted

October 3, 2021

First Submitted That Met QC Criteria

October 3, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1102/2020/Oss/AOUFe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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