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Be Part of Research - Trial Details - SC IL-1Ra in SAH - Phase III Trial (SCIL)

SC IL-1Ra in SAH - Phase III Trial (SCIL)

Medical Conditions

Subarachnoid Hemorrhage


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


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 Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment.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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2018 Apr 2024

Interventional

Intervention Type : Drug
Intervention Description : 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).

Intervention Arm Group : IL-1Ra twice daily

Intervention Type : Drug
Intervention Description : 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).

Intervention Arm Group : Placebo twice daily



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Queens Medical Centre
    Nottingham
    NG7 2UH
  • St George's Hospital
    London
    SW17 0QT
  • Charing Cross Hospital
    London
    W6 8RF
  • Addenbrookes Hospital
    Cambridge
    CB2 0QQ
  • Southampton General Hospital
    Southampton
    SO16 6YD
  • Royal Preston Hospital
    Preston
    PR2 9HT
  • Southmead Hospital
    Bristol
    BS10 5NB
  • Royal Sussex County Hospital
    Brighton
    BN2 5BE
  • Royal Stoke University Hospital
    Stoke-on-Trent
    ST4 6QG
  • The Walton Centre
    Liverpool
    L9 7LJ
  • Royal London Hospital
    London
    E1 1FR
  • Royal Hallamshire Hospital
    Sheffield
    South Yorkshire
    S10 2JF
  • University Hospital of Wales
    Cardiff
    Wales
    CF14 4XW
  • Derriford Hospital
    Plymouth
    Devon
    Pl6 8DH
  • Leeds General Infirmary
    Leeds
    Yorkshire
    LS1 3EX
  • National Hospital for Neurology and Neurosurgery, Queen Square
    London
    WC1N 3BG
  • Northern Care Alliance NHS Foundation Trust
    Manchester


The study is sponsored by University of Manchester and funded by National Institute for Health Research, United Kingdom; Clinical Trials Unit, Manchester; Northern Care Alliance NHS Foundation Trust.




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Read full details for Trial ID: NCT03249207
Last updated 17 November 2023

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