Can IL-1ra reduce inflammation and improve clinical outcome following aneurysmal SAH?
- Conditions
- StrokeNervous System Diseases
- Registration Number
- ISRCTN12961797
- Lead Sponsor
- The University of Manchester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 612
1. Patients with CT positive spontaneous SAH admitted to a participating neurosurgical centre where written informed consent can be obtained and study drug can be administered within 72 hours of ictus
2. No concomitant health problems that, in the opinion of the PI or designee, would interfere with participation, administration of study drug or assessment of outcomes including safety
3. Willing and able to give informed consent or consent available from a patient representative for trial inclusion including agreement in principle to receive study drug and undergo all study assessments
4. Male or female aged 18 years or above
Current participant exclusion criteria as of 14/08/2023:
1. Unconfirmed or uncertain diagnosis of spontaneous SAH
2. Known active tuberculosis or active hepatitis
3. Known active malignancy
4. Known Still's Disease
5. Neutropenia (ANC <1.5 x 109/L )
6. Abnormal renal function (creatinine clearance or estimated Glomerular Filtration Rate (eGFR) < 30 ml/minute) documented in the last 3 months prior to this SAH
7. Live vaccinations within the last 10 days of this SAH
8. Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial
9. Current treatment with TNF antagonists
10. Known to have participated in a clinical trial of an investigational agent or device in the 30 days prior to ictus
11. Known to have participated in a clinical trial of an investigational agent or device within 5 half-lives (of the previous agent or device) prior to ictus
12. Known to be pregnant or breastfeeding or inability to reliably confirm that the patient is not pregnant
13. Clinically significant serious concurrent medical condition, pre-morbid illnesses, or concurrent serious infection (including confirmed or suspected COVID-19 infection), at the PI’s (or designee’s) discretion, which could affect the safety or tolerability of the intervention
14. Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC
15. Known allergy to other products that are produced by DNA technology using the microorganism E. coli (e.g. E.coli derived protein)
16. Current treatment with IL-6 or IL-1 inhibitors or drugs affecting the IL-1 axis
17. History of DRESS syndrome
Previous participant exclusion criteria:
1. Unconfirmed or uncertain diagnosis of spontaneous SAH
2. Known active tuberculosis or active hepatitis
3. Known active malignancy
4. Neutropenia (ANC <1.5 x 109/L )
5. Abnormal renal function (creatinine clearance or estimated Glomerular Filtration Rate (eGFR) < 30 ml/minute) documented in the last 3 months prior to this SAH
6. Live vaccinations within the last 10 days of this SAH
7. Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial
8. Previous or current treatment with medication suspected of interacting with IL-1Ra, listed in the drug SmPC
9. Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days or 5 half-lives of enrolment (whichever is longer) of ictus, or for the period determined by the protocol of the trial / study the patient has taken part in
10. Known to be pregnant or breast feeding or inability to reliably confirm that the patient is not pregnant
11. Clinically significant serious concurrent medical condition, pre morbid illnesses, or concurrent serious infection, at the PI’s (or designee’s) discretion, which could affect the safety or tolerability of the intervention
12. Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC
13. Known allergy to
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical outcome is measured using the modified Rankin Scale (mRS) questionnaire at 6 months.
- Secondary Outcome Measures
Name Time Method <br> 1. Mood is measured using the Hospital Anxiety and Depression Scale questionnaire at 6 months<br> 2. Fatigue is measured using the GM-SAT Fatigue question and Fatigue Severity Score questionnaire at 6 months<br> 3. Quality of life is measured using the EQ-5D-5L questionnaire at 6 months<br>