Chronic Subdural HematomaTHERCANCT05079295
Management of Anticoagulants and Antithrombotics in Patients With CSDH
An observational study of Chronic Subdural Hematoma and Anticoagulant-induced Bleeding, run by University Hospital of Ferrara at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Chronic Subdural Hematoma, Anticoagulant-induced Bleeding, Thromboembolic Stroke
- What is being tested?
- CSDH evacuation
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2021to 20 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Age > 18 years old
- Informed consent
- Evidence of CSDH which needs surgery
- patients taking antithrombotics or anticoagulants
Who cannot join
- previous surgery for CSDH
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Hospital Sant'Anna
Ferrara, Emilia-Romagna, 44124
Alba Scerrati, MD, +39532236292, scrlba@unife.it
Pasquale De Bonis, Prof
About this study
Official title: 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.
- Conditions
- Chronic Subdural Hematoma, Anticoagulant-induced Bleeding, Thromboembolic Stroke, Cardiovascular Stroke
- Being tested
- CSDH evacuation
- Keywords
- chronic subdural hematoma, anticoagulants, antithrombotics, thromboembolic disease, cardiovascular risk
- Medical subject headings
- Hematoma, Subdural, Chronic, Myocardial Infarction, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSDH evacuationProcedure or surgery
Burr hole for chronic subdural hematomas
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients taking anticoagulants or antithrombotics Receives: Procedure: CSDH evacuation | |
| Group 2 | Controls Receives: Procedure: CSDH evacuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start20 Feb 2021
- Primary completion20 Feb 2023 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dott.ssa Alba Scerrati, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079295
- Sponsor's protocol ID
- 1102/2020/Oss/AOUFe
- Acronym
- THERCA
- Status last verified
- Nov 2022
- First submitted
- 3 Oct 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboembolic and Hemorrhagic Risk Evaluation in Surgically Treated Patients With CSDH Taking Anticoagulants and Antithrombotics
- ClinicalTrials.gov ID
- NCT05079295
- Acronym / sponsor ID
- THERCA / 1102/2020/Oss/AOUFe
- Conditions
- Chronic Subdural Hematoma, Anticoagulant-induced Bleeding, Thromboembolic Stroke, Cardiovascular Stroke
- Keywords
- chronic subdural hematoma, anticoagulants, antithrombotics, thromboembolic disease, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 20 Feb 2023 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: CSDH evacuationPatients taking anticoagulants or antithrombotics |
| Group 2 | – | Procedure: CSDH evacuationControls |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- Age > 18 years old
- Informed consent
- Evidence of CSDH which needs surgery
- patients taking antithrombotics or anticoagulants
Key exclusion criteria (1 listed)
- previous surgery for CSDH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSDH evacuationBurr hole for chronic subdural hematomas | Procedure or surgery | Group 1, Group 2 |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Subdural Hematoma and Anticoagulant-induced Bleeding, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemorrhagic or thromboembolic events evaluation (time frame: up to 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.