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

Phase 3

Recruiting

• Conditions: bleeding within the skull.; Chronic subdural hematoma; 10007963; 10009720

• Registration Number: NL-OMON55350
• Lead Sponsor: Haaglanden Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 420

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Presence of a newly diagnosed CSDH: An isodens or hypodens haematoma on
cranial CT-scan. Hyperdens components may be present but must compromise less
than 1/3 of the haematoma.
- Clinical symptoms must correlate to the cerebral lesion.
- Patient would be an eligible candidate for BHC, based on the clinical
condition and radiologic appearance of CSDH.
- Severity of symptoms must be MGS 1-3.
- Subject must be 18 years or older.
- Written informed consent.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- MGS 0 or MGS 4.
- An acute subdural haematoma.
- Presence of a minimal CSDH on cranial CT, which is technically not drainable
by BHC (i.e. haematoma thickness < 10 mm).
- Pregnancy.
- Cerebrospinal fluid shunt in situ.
- Known hypersensitivity to DXM.
- Known ulceration in the gastro-intestinal tract.
- Uncontrolled diabetes mellitus (DM), defined as a HbA1C value > 8% (64
mmol/mol).
- 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).
, Additional exclusion criteria concerning participation of the MRI-substudy:
- Subjects with a contra-indication to an MRI examination.
- Subjects who have a documented allergy to MRI contrast media or a
contra-indication for contrast-media.
- Claustrophobia.
- Having any physical or mental complaints (i.e. delirious condition with motor
disturbance) that interferes with a (safe) MRI-procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the functional outcome (expressed by the modified Rankin Scale,<br /><br>mRS) and the cost-effectiveness after initial dexamethasone (DXM) therapy<br /><br>versus primary surgery in symptomatic patients with a newly diagnosed chronic<br /><br>subdural hematoma (CSDH), after respectively 3 and 12 months.</p><br>