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| ID | Type | Description | Link |
|---|---|---|---|
| Eudra CT nummer 2009-010058-37 |
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No effect of the ACE inhibitor evaluated halfway in the study
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| Name | Class |
|---|---|
| Alice Brenaa Foundation | OTHER |
| The Hede Nielsen Family Foundation | OTHER |
| Overlægerådets legatudvalg | UNKNOWN |
| University of Southern Denmark |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACE inhibitor | Active Comparator | patients randomized to this arm will be treated with ACE inhibitors after surgery |
|
| Placebo | Placebo Comparator | patients randomized to this arm will be treated with placebo after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perindopril | Drug | 2,5 mg daily for 3 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Size of Chronic Subdural Hematoma (CSDH) | Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Composition of Chronic Subdural Hematoma Fluid | Post-Hoc Outcome Measure | years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frantz R Poulsen, MD, PhD | Department of Neurosurgery, Odense University Hospital | Principal Investigator |
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Neurosurgical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | ACE Inhibitor | Perindopril: 2,5 mg daily for 3 months |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients with CSDH and indication for surgery. Either male or female
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | three months placebo treatment after surgical CSDH evacuation |
| BG001 | Perindopril | three months perindopril treatment after surgical CSDH evacuation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Size of Chronic Subdural Hematoma (CSDH) | Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans | Posted | Mean | Standard Deviation | cm^3 | 3 months |
|
|
3 months
Low dose of a well tolerated and well known drug in the active drug arm
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACE Inhibitor | Active compound | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frantz Rom Poulsen, Professor, consultant | Odense University Hospital, Odense, Denmark | 0045 65413600 | frantz.r.poulsen@rsyd.dk |
| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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| ID | Term |
|---|---|
| D020913 | Perindopril |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| OTHER |
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| Placebo | Drug | Placebo dayli for 3 months |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | CSDH and indication for surgical evacuation | Count of Participants | Participants |
|
| Region of Enrollment | Prospective, randomized | Many patients were not able to consent and the neurosurgeon on call were too busy to include in the project | Number | participants |
|
| Size of Chronic Subdural Hematoma | Mean | Standard Deviation | cm^3 |
|
|
| Secondary | Composition of Chronic Subdural Hematoma Fluid | Post-Hoc Outcome Measure | Analysis will not be performed due to insufficient funding and the samples will be destroyed | Posted | years |
|
|
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Placebo | Inactive placebo | 0 | 22 | 0 | 22 | 0 | 22 |
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| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |