Treatment of poor-grade subarachnoid haemorrhage trial 2

Not Applicable

Completed

• Conditions: Subarachnoid haemorrhage; Circulatory System

• Registration Number: ISRCTN15960635
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34292691/ (added 05/04/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-05
• Study Completion: 2018-12-18
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 305

Inclusion Criteria

1. Aged 18-80 years
2. WFNS grade 4 or 5 SAH (grade for trial eligibility purposes is the WFNS grade recorded at first medical assessment following: hospital attendance AND confirmation of the diagnosis of SAH – by CT (or MRI) and/or lumbar puncture)
3. Assent obtained from next of kin, professional consultee or welfare attorney/nearest relative

Exclusion Criteria

1.WFNS grade 1-3, or uncertain WFNS grade (where patient recovers quickly and proves not to be of true high grade):
1.1. Patients of uncertain grade on transfer to a neuroscience unit where a formal sedation hold is undertaken at the neurosciences centre and the patient is established to be truly grade 4 or 5 will be eligible for trial
1.2. This will also apply to patients of uncertain grade undergoing sedation hold after insertion of external ventricular drain (EVD) or other early intervention for hydrocephalus
2. Signs of coning or brain death not promptly reversed by anti-cerebral oedema treatment
3. Pure intraventricular haemorrhage (no SAH)
4. Large intracerebral haematoma which requires immediate clot evacuation
5. Significant aneurysmal SAH-related haemodynamic instability
6. Lack of clinical equipoise
7. Lack of assent/consent
8. Pregnancy
9. Pre SAH modified Rankin score >2
10. Pre-existing severe co-morbidity such that clinical follow up at 12 months is judged unlikely
11. Non-saccular, Mycotic, giant or other atypical aneurysm

For MRI sub study only
Known absolute contra indication to MRI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional outcome is measured by ordinal analysis of modified Rankin Score (mRS) at 12 months.

Secondary Outcome Measures

Name	Time	Method
<br> 1. mRS is measured by dichotomisation of scores 0-3 (no or significant symptoms) vs 4-6 (severe symptoms and mortality) and 0-2 (no or few symptoms) v 3-6 (significant symptoms and mortality) at 12 months<br> 2. Mortality rate is measured by -survival analysis at 30 days, six months and 12 months<br> 3. Re-bleeding rate is measured by the number of re-bleeds that have occurred at 12 months<br> 4. Treatment related complication rate & SAE report rates are measured by the number of treatment related complications and SAEs that have occurred at 12 months<br> 5. Time to hospital discharge is measured by length of time in hospital from randomisation at discharge date<br> 6. Length of ITU/HDU stay is measured by length of time in ITU/HDU from randomisation at discharge date<br> 7. Functional outcome is measured by ordinal analysis of modified Rankin Score (mRS) at 6 months<br>