A randomised blinded trial of a steroid (dexamethasone) compared to a placebo for adult patients who have suffered a chronic bleed on the surface of the brain

A randomised, double blind, placebo-controlled trial of a two-week course of dexamethasone for adult patients with a symptomatic chronic subdural haematoma. - Dex - CSDH Trial

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004948-35-GB

Enrollment

750

Registered

2015-02-20

Start date

2015-03-20

Completion date

Unknown

Last updated

2016-06-13

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

Conditions

chronic subdural haematoma MedDRA version: 19.0 Level: PT Classification code 10042361 Term: Subdural haematoma System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: Dexamethasone Tablets BP 2.0mg Product Name: Dexamethasone Pharmaceutical Form: Capsule INN or Proposed INN: Dexamethasone CAS Number: 50-02-2 Concentration unit: mg/g milligram(s)/gram Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Adult patients (aged 18 years or older) 2.Symptomatic CSDH confirmed on cranial imaging (predominantly hypodense or isodense crescentic collection along the cerebral convexity on CT). 3.Informed consent or IHP authorisation Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 450

Exclusion criteria

Exclusion criteria: 1.Patients with conditions where steroids are clearly contra-indicated 2.Patients who are already on (or within 1 month) regular oral or intravenous steroids 3.Previous enrolment in this trial for a prior episode. 4.Patients in whom the time interval from admission to neurosurgical unit to initiation of trial drug exceeds 72 hours. 5. CSDH in the presence of a cerebrospinal fluid (CSF) shunt. 6. Lactose intolerance or any known hypersensitivity to dexamethasone or any of the IMP (investigational medicinal product) excipients 7. Patients with a history of psychotic disorders 8. Concurrent enrolment in any other trial of an investigational medicinal product 9. Previous cranial neurosurgery (sub-study only) 10. Active malignancy(sub-study only) 11. Currently receiving immunosuppressive drug therapy (sub-study only) 12. Renal dysfunction (MRI sub-study only) 13. Pacemaker or metal implants (MRI sub-study only)

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Secondary objectives: -Number of CSDH- related surgical interventions undertaken during the index admission -Number of CSDH-related surgical interventions undertaken during subsequent admissions in the follow-up period. -Outcome questionnaires to assess quality of life and health at 3 and 6 months -Length of stay in neurosurgical unit. -Discharge destination from neurosurgical unit -Length of stay in secondary care (local hospital). -Health-economic analysis. -Adverse events. -Assess the biological action of dexamethasone within CSDH fluid. -Assess the role of dexamethasone in cerebral perfusion (blood flow) and oedema (swelling) in CSDH.;Main Objective: To investigate whether a two-week course of dexamethasone can improve the 6 month functional outcome of patients with symptomatic chronic Subdural Haematoma (CSDH) by reducing the rate of surgical intervention and the recurrence rate.;Primary end point(s): The clinical outcome, as measured by the Modified Rankin Scale (mRS) at 6 months;Timepoint(s) of evaluation of this end point: 6 months post randomisation	—

Measure

Time frame

Secondary Objective: Secondary objectives: -Number of CSDH- related surgical interventions undertaken during the index admission -Number of CSDH-related surgical interventions undertaken during subsequent admissions in the follow-up period. -Outcome questionnaires to assess quality of life and health at 3 and 6 months -Length of stay in neurosurgical unit. -Discharge destination from neurosurgical unit -Length of stay in secondary care (local hospital). -Health-economic analysis. -Adverse events. -Assess the biological action of dexamethasone within CSDH fluid. -Assess the role of dexamethasone in cerebral perfusion (blood flow) and oedema (swelling) in CSDH.;Main Objective: To investigate whether a two-week course of dexamethasone can improve the 6 month functional outcome of patients with symptomatic chronic Subdural Haematoma (CSDH) by reducing the rate of surgical intervention and the recurrence rate.;Primary end point(s): The clinical outcome, as measured by the Modified Rankin Scale (mRS) at 6 months;Timepoint(s) of evaluation of this end point: 6 months post randomisation

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Secondary

Measure	Time frame
Secondary end point(s): 1.Number of CSDH-related surgical interventions undertaken during the index admission. 2.Number of CSDH-related surgical interventions undertaken during subsequent admissions 3.Glasgow Coma Scale (GCS) 4.mRS score 5.Barthel Index 6.Mortality 7.EuroQOL (EQ-5D) 8.Length of stay in hospital. 9.Discharge destination from NSU. 10.Length of stay in rehabilitation. 11.Health-economic analysis. 12.Adverse events. 13.Assessment of inflammatory mediators in CSDH fluid and blood. 14.Cerebral perfusion measured on MRI and TCD. 15.Cerebral swelling measure on MRI.;Timepoint(s) of evaluation of this end point: Assessment of 1-9 and 12 at discharge form Neurosurgical unit Assessment of 6 and 12 at day 15 and day 30 Assessment of 2,4,5,7 at 3 months Assessment of 2,3,5,6,7 and 11 at 6 months Assessment of 13 at time of surgery (if performed) and up to 48hrs post-operatively. Assessment of 14 and 15 within 72hrs of admission, repeated within 14 days of admission and at 6-12 weeks.	—

Measure

Time frame

Secondary end point(s): 1.Number of CSDH-related surgical interventions undertaken during the index admission. 2.Number of CSDH-related surgical interventions undertaken during subsequent admissions 3.Glasgow Coma Scale (GCS) 4.mRS score 5.Barthel Index 6.Mortality 7.EuroQOL (EQ-5D) 8.Length of stay in hospital. 9.Discharge destination from NSU. 10.Length of stay in rehabilitation. 11.Health-economic analysis. 12.Adverse events. 13.Assessment of inflammatory mediators in CSDH fluid and blood. 14.Cerebral perfusion measured on MRI and TCD. 15.Cerebral swelling measure on MRI.;Timepoint(s) of evaluation of this end point: Assessment of 1-9 and 12 at discharge form Neurosurgical unit Assessment of 6 and 12 at day 15 and day 30 Assessment of 2,4,5,7 at 3 months Assessment of 2,3,5,6,7 and 11 at 6 months Assessment of 13 at time of surgery (if performed) and up to 48hrs post-operatively. Assessment of 14 and 15 within 72hrs of admission, repeated within 14 days of admission and at 6-12 weeks.

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Countries

United Kingdom

Contacts

Public ContactCarrie Bayliss

Cambridge University Hospitals NHS Foundation Trust

cctu@addenbrookes.nhs.uk01223348158

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026