E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic subdural hematoma. |
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E.1.1.1 | Medical condition in easily understood language |
Bleeding within the skull. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049163 |
E.1.2 | Term | Chronic subdural hematoma |
E.1.2 | System Organ Class | 100000004863 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the effect of initial dexamethasone therapy compared to primary surgery on functional outcome (as expressed by the modified Rankin Score, mRS) in patients with a chronic subdural hematoma after 3 months. |
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E.2.2 | Secondary objectives of the trial |
To compare other variables in both subject groups (dexamethasone versus surgery), such as:
- Clinical outcome at discharge, 2 weeks and 6 months (expressed by mRS and Markwalder Grading Score, MGS).
- Number of surgical intervention prevented in intervention (DXM) group.
- Quality of life (as expressed by Short Form (36) Health Survey, at 6 months).
- Haematoma thickness (after 2 weeks).
- Haematoma recurrence: Recurrence of symptoms and neurological sign after initial improvement with persistence, recurrence or increase of CSDH on CT-scan (within the first 6 months).
- Complications (during hospital stay and DXM therapy).
- Mortality (within the first 3 months).
- Drug related adverse events.
- Duration of hospital stay.
- Costs.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Presence of a chronic subdural hematoma: An isodens or hypodens hematoma on cranial CT-scan. Hyperdens components may be present but must compromise less than 1/3 of the hematoma.
- Clinical symptoms must correlate to the cerebral lesion.
- Severity of symptoms must be Marwalder Grading Score 1-3.
- Subject must be 18 years or older.
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- An acute subdural haematoma.
- Pregnancy.
- Known hypersensitivity to DXM.
- Known ulceration in the gastro-intestinal tract.
- Uncontrolled diabetes mellitus (DM).
- Clinical suspicion of an acute systemic infection (fever, leucocytosis, elevated C-reactive protein (CRP)).
- History of gastro-intestinal bleeding.
- Glaucoma.
- Previous history of severe affective disorders on steroids (i.e. psychosis).
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E.5 End points |
E.5.1 | Primary end point(s) |
The functional outcome (as expressed by the modified Rankin Scale, mRS) in patients with a chronic subdural hematoma. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary Objectives:
- Clinical outcome at discharge, 2 weeks and 6 months (expressed by mRS and Markwalder Grading Score, MGS).
- Number of surgical intervention prevented in intervention (DXM) group.
- Quality of life (as expressed by Short Form (36) Health Survey, at 6 months).
- Haematoma thickness (after 2 weeks).
- Haematoma recurrence: Recurrence of symptoms and neurological sign after initial improvement with persistence, recurrence or increase of CSDH on CT-scan (within the first 6 months).
- Complications (during hospital stay and DXM therapy).
- Mortality (within the first 3 months).
- Drug related adverse events.
- Duration of hospital stay.
- Costs.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Surgery (by performing a burr hole craniostomy) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |