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Investigating imaging and clinical decision tools for identifying and ruling out subarachnoid haemorrhage in patients presenting with an acute severe headache to UK Emergency Departments

Subarachnoid Haemorrhage in the Emergency Department (SHED)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN18417679
Enrollment
9000
Registered
2020-11-17
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-08-22

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

Conditions

Subarachnoid haemorrhage and acute severe headache Circulatory System Subarachnoid haemorrhage and acute severe headache

Interventions

As an observational study, there will be no change to clinical practice. Headache features will be prospectively collected. Relevant investigations of CT brain, lumbar puncture, and CT-angiogram will

Sponsors

Northern Care Alliance
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Presenting with a non-traumatic acute headache that reaches maximal intensity within one hour to UK Emergency Departments (ED) or equivalent acute secondary care environment

Exclusion criteria

Exclusion criteria: 1. Direct head trauma in the previous 7 days 2. Returning for reassessment of the same headache within the recruitment period 3. Established diagnosis of subarachnoid haemorrhage, brain neoplasm, ventricular shunt or hydrocephalus prior to attendance at the emergency department. 4. Focal neurological deficit 5. Headache with onset >14 days prior to attendance 6. Recurrent headaches defined as =3 headaches of similar character and intensity as presenting headache 7. Transfer from another hospital with confirmed subarachnoid haemorrhage 8. Prisoner presenting to ED/secondary care 9. Patient currently under detained Mental health act, presenting to ED/secondary care

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 18/05/2021: 1. External validation of a 6-hour CT brain rule out strategy for alert (defined as awake and fully orientated or GCS 15/15) patients presenting with acute non-traumatic headache, where there is clinical concern for SAH using prospectively collected data. Previous primary outcome measure: 1. External validation of the proposed 6 h CT brain rule out strategy for alert patients (defined as awake and fully orientated or GCS 15/15) presenting with acute non-traumatic headache, suggestive of subarachnoid haemorrhage using prospectively collected data

Secondary

MeasureTime frame
1. Change in sensitivity of CT brain imaging in patients presenting with acute severe headache over hourly intervals from 6 to 24 h after onset of headache using prospectively collected CT brain data 2. Validation of the Ottawa subarachnoid haemorrhage clinical decision rule in patients presenting with acute non-traumatic headache using prospectively collected clinical notes, primary care contact data, and HES data Added 18/05/2021: The prevalence of subarachnoid haemorrhage in patients under 40 years of age identified from the data collected as any of the following: 1. Subarachnoid blood present on unenhanced CT reported by a trained radiologist. Site CT characteristics will be collected to include minimum criteria applied for inclusion in the final analysis, as follows: 1.1. A 3rd generation multi-slice scanner (4 to 320 slices/rotation) 1.2. 5 – 7.5 mm cuts for brain 1.3. 2.5 – 5 mm cuts for the posterior fossa 2. Subarachnoid blood present on CT-angiogram or MR-angiogram reported by a trained radiologist 3. CSF findings consistent with SAH according to the 2008 National Biochemist reporting guideline. The vast majority of UK laboratories processing CSF samples adhere to the 2008 clinical biochemistry guidelines. However, for those sites identified as using xanthochromia or red blood cells in lieu of 2008 criteria, the study team will adopt criteria stipulated in the original paper by Perry et al. 4. Visible xanthochromia. Red blood cells (>5 × 10e6/l) in the final tube of cerebrospinal fluid collected and an aneurysm identified on cerebral angiography (digital subtraction, computed tomography, or magnetic resonance angiography) For patients who are evaluated for acute severe headache reaching maximal intensity within 1 hour in UK emergency departments.

Countries

England, United Kingdom

Contacts

Public ContactRobert Hirst
tern@rcem.ac.uk+44 (0)7506 385159

Outcome results

None listed

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