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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| Clinical Trials Unit, Manchester | OTHER |
| Northern Care Alliance NHS Foundation Trust | OTHER |
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This phase III trial will establish whether IL-1Ra, with sub-cutaneous (SC) administration twice daily for up to 21 days post aneurysmal subarachnoid haemorrhage (aSAH), improves clinical outcome as measured by ordinal shift in mRS at 6 months.
Patients with SAH transferred to a neurosurgical centre will be identified and approached for study participation. Following consent, patients will be randomised to receive either IL-1Ra or placebo for a maximum of 21 days from onset of symptoms. Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment. Blood samples for plasma IL-6 will be obtained prior to randomisation and at day 3-5 post randomisation for IL-6 & IL-1 measurement. Safety will be measured at 30 days post randomisation and outcome assessed at 6 months post randomisation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IL-1Ra twice daily | Active Comparator |
| |
| Placebo twice daily | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL-1Ra | Drug | Doses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre). |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal shift in modified Rankin Score (mRS) | 6 months post randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of mood using HADS | 6 months post randomisation | |
| Measurement of fatigue using Fatigue score | 6 months post randomisation | |
| Measurement of quality of life using EQ-5D-5L score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew King | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Derriford Hospital | Plymouth | Devon | PL6 8DH | United Kingdom | ||
| Royal Hallamshire Hospital |
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| IL-1Ra Placebo | Drug | Doses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre). |
|
| 6 months post randomisation |
| Sheffield |
| South Yorkshire |
| S10 2JF |
| United Kingdom |
| University Hospital of Wales | Cardiff | Wales | CF14 4XW | United Kingdom |
| Leeds General Infirmary | Leeds | Yorkshire | LS1 3EX | United Kingdom |
| Royal Sussex County Hospital | Brighton | BN2 5BE | United Kingdom |
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom |
| The Walton Centre | Liverpool | L9 7LJ | United Kingdom |
| Royal London Hospital | London | E1 1FR | United Kingdom |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| National Hospital for Neurology and Neurosurgery, Queen Square | London | WC1N 3BG | United Kingdom |
| Northern Care Alliance NHS Foundation Trust | Manchester | United Kingdom |
| Queens Medical Centre | Nottingham | NG7 2UH | United Kingdom |
| Royal Preston Hospital | Preston | PR2 9HT | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| Royal Stoke University Hospital | Stoke-on-Trent | ST4 6QG | United Kingdom |
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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