Hematoma, Subdural, ChronicKSDHNCT00915928
Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors
A study testing Perindopril in people with Hematoma, Subdural, Chronic, run by Odense University Hospital.
Trial summary
The project aims at investigating if treatment with the Angiotensin Converting Enzyme inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma will decrease the risc of recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematoma, Subdural, Chronic
- What is being tested?
- Perindopril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic subdural hematoma that needs surgical evacuation
- Age > 18 year
Who cannot join
- Lack of compliance
- Kidney artery stenosis
- Stenosis of the aorta
- Severely decreased kidney function
- Allergy or intolerance/contraindications toward ACE inhibitors
- Already in ACE inhibitor treatment
Show all 11Show fewer
- Coagulopathies
- Malignant disorders
- Fertile women
- Other neurological disorders
- Treatment with pharmaceuticals contraindicating treatment with ACE inhibitors
About this study
The project aims at investigating if treatment with the Angiotensin Converting Enzyme inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma will decrease the risc of recurrence.
Read the detailed description
Previous studies have indicated that treatment with ACE inhibitors can reduce the risk of recurrence of CSDH after surgical evacuation. This randomized clinical trial was designed to investigate this
- Conditions
- Hematoma, Subdural, Chronic
- Being tested
- Perindopril, Placebo
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerindoprilDrug
Also called coversyl
2,5 mg daily for 3 months
PlaceboDrug
Placebo dayli for 3 months
| Study group | Role | What they receive |
|---|---|---|
| ACE inhibitor | Active comparator | patients randomized to this arm will be treated with ACE inhibitors after surgery Receives: Drug: Perindopril |
| Placebo | Placebo comparator | patients randomized to this arm will be treated with placebo after surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of Chronic Subdural Hematoma (CSDH)
Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans
Measured: 3 months
Secondary outcomes (1)
Composition of Chronic Subdural Hematoma Fluid
Post-Hoc Outcome Measure
Measured: years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2012
- Study completionJun 2012
Why it stopped: No effect of the ACE inhibitor evaluated halfway in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematoma, Subdural, ChronicStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alice Brenaa Foundation, The Hede Nielsen Family Foundation, Overlægerådets legatudvalg, University of Southern Denmark
- Responsible party
- Principal investigator, Frantz Rom Poulsen, Odense University Hospital
- Investigators
- Frantz R Poulsen, MD, PhD, Principal investigator, Department of Neurosurgery, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915928
- Sponsor's protocol ID
- Chronic Subdural Hematoma
- Other IDs
- Eudra CT nummer 2009-010058-37
- Acronym
- KSDH
- Status last verified
- Aug 2020
- First submitted
- 3 Jun 2009
- Last updated
- 19 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors
- ClinicalTrials.gov ID
- NCT00915928
- Acronym / sponsor ID
- KSDH / Chronic Subdural Hematoma
- Conditions
- Hematoma, Subdural, Chronic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No effect of the ACE inhibitor evaluated halfway in the study
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Alice Brenaa Foundation, The Hede Nielsen Family Foundation, Overlægerådets legatudvalg, University of Southern Denmark
- Study start
- Jul 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Jun 2009 (estimated)
- Results
- Posted 19 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project aims at investigating if treatment with the Angiotensin Converting Enzyme inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma will decrease the risc of recurrence.
Detailed description
Previous studies have indicated that treatment with ACE inhibitors can reduce the risk of recurrence of CSDH after surgical evacuation. This randomized clinical trial was designed to investigate this
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACE inhibitor | Active comparator | Drug: Perindoprilpatients randomized to this arm will be treated with ACE inhibitors after surgery |
| Placebo | Placebo comparator | Drug: Placebopatients randomized to this arm will be treated with placebo after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chronic subdural hematoma that needs surgical evacuation
- Age > 18 year
Key exclusion criteria (11 listed)
- Lack of compliance
- Kidney artery stenosis
- Stenosis of the aorta
- Severely decreased kidney function
- Allergy or intolerance/contraindications toward ACE inhibitors
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 |
|---|---|---|
| PerindoprilAlso: coversyl2,5 mg daily for 3 months | Drug | ACE inhibitor |
| PlaceboPlacebo dayli for 3 months | Drug | Placebo |
Primary outcome
Size of Chronic Subdural Hematoma (CSDH)
Time frame: 3 months
Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans
1 secondary outcome
Composition of Chronic Subdural Hematoma Fluid
Time frame: years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Frantz R Poulsen, MD, PhD principal investigator
Department of Neurosurgery, Odense University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Perindopril in people with Hematoma, Subdural, Chronic, run by Odense University Hospital.
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 2 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of Chronic Subdural Hematoma (CSDH) (time frame: 3 months). 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 19 Aug 2020.