Effect of dexamethasone (DXM) therapy in patients with a brain bleed: A comparision of a non-operative treatment versus surgery on patient recovery.

Dexamethasone (DXM) therapy in symptomatic patients with chronic subdural hematoma (DECSA - trial): Effect of corticosteroid therapy versus primary surgery on clinical outcome.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21208

Enrollment

170

Registered

2016-10-17

Start date

2016-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EN: Chronic subdural hematoma, CSDH, dexamethasone, DXM NL: Chronisch subduraal hematoom, dexamethason

Interventions

Intervention arm: Patients in the intervention (DXM) arm will receive DMX in a daily dosage of 16 mg (8 mg every 12 hours) on day 1 to 4. Thereafter, DXM will be tapered down by halve every 3 days (4

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1) Presence of a chronic subdural haematoma 2) Clinical symptoms must correlate to the cerebral lesion 3) Severity of symptoms must be MGS 1-3 4) Subject must be 18 years or older.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1) an acute subdural haematoma 2) pregnancy 3) known hypersensitivity to DXM 4) known ulceration in the gastro-intestinal tract, 5) uncontrolled diabetes mellitus (DM) defined as a HbA1C value > 8% (64 mmol/mol) 6) clinical suspicion of an acute systemic infection (fever, leucocytosis, elevated C-reactive protein (CRP) 7) history of gastro-intestinal bleeding 8) glaucoma 9) previous history of severe affective disorders on steroids (i.e. psychosis)

Design outcomes

Primary

Measure	Time frame
The main primary endpoint in is the functional outcome, as expressed by mRS, in both treatment arms at 3 months.	—

Secondary

Measure	Time frame
Secondary outcomes include: clinical outcome at discharge, 2 weeks and at 6 months (expressed by mRS and MGS), the number of surgical intervention prevented in the DXM group, quality of life (as expressed by the Short Form – 36 Health Survey, SF-36) at 6 months, haematoma thickness after 2 weeks, haematoma recurrence (defined as recurrence of symptoms and neurological signs after initial improvement with persistence, recurrence or increase of CSDH on follow up cranial CT) during the first 6 months, complications and drug related adverse events, mortality, duration of hospital stay and health care costs in both subject groups.	—

Measure

Time frame

Secondary outcomes include: clinical outcome at discharge, 2 weeks and at 6 months (expressed by mRS and MGS), the number of surgical intervention prevented in the DXM group, quality of life (as expressed by the Short Form – 36 Health Survey, SF-36) at 6 months, haematoma thickness after 2 weeks, haematoma recurrence (defined as recurrence of symptoms and neurological signs after initial improvement with persistence, recurrence or increase of CSDH on follow up cranial CT) during the first 6 months, complications and drug related adverse events, mortality, duration of hospital stay and health care costs in both subject groups.

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Contacts

Public ContactW. Peul

Leids Universitair Medisch Centrum Postzone J11-Q

w.c.peul@lumc.nl+31 (0)71 5262144

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)