Subarachnoid haemorrhage MedDRA version: 14.0 Level: PT Classification code 10042316 Term: Subarachnoid haemorrhage System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Kineret (anakinra)
Product Name: Kineret
Product Code: L04AA14
Pharmaceutical Form: Solution for injection
INN or Proposed I
Sponsors
Salford Royal NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion:Patients with confirmed spontaneous aSAH who are admitted to the neurosurgical department at SRFT where consent can be obtained and drug administered within 72 hours. No concomitant health problems that, in the opinion of the Principal Investigator (PI) or designee, would interfere with participation, administration of study treatment or assessment of outcomes including safety, for example, pre-existing malignancy. Renal function within normal limits (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Unconfirmed or uncertain diagnosis of spontaneous aSAH. Known or suspected infection in the preceeding 2 weeks or at the time of consideration for the study. Known allergy to E. coli or any of the constituents of the study medication as established from the patient themselves, reliable representative and clinical records. Previous or concurrent treatment with recombinant IL-1Ra known at the time of study entry. Previous or current treatment with medication suspected of interacting with recombinant IL-1Ra, such as TNF-a inhibitors. Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days or for the period determined by the protocol of the study the patient has taken part in. Known or planned pregnancy (pregnancy test to be performed in women of child-bearing potential) or breast-feeding. Clinically significant concurrent medical condition, at the PI’s (or designee’s) discretion, which could affect the safety, tolerability, or efficacy in this study. Previous inclusion in the current study (known prior to inclusion). Inability or unwillingness of patient or patient’s personal representative to give written informed consent. Likely to be transferred from the centre within eight days of admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: What effect does the specific anti-inflammatory drug (IL-1Ra) have on the levels of a specific inflammatory protein (IL-6) in blood between 3-8 days after a brain haemorrhage?;Primary end point(s): To determine area under curve (AUC) of IL-6 concentration from day 3 to day 8 post-ictus, in patients receiving IL-1Ra relative to those who do not.;Secondary Objective: Secondary question 1. What effect does the specific anti-inflammatory drug (IL-1Ra) have on the levels of other inflammatory proteins in blood between 3-8 days after a brain haemorrhage? Secondary question 2. What effect does the specific anti-inflammatory drug (IL-1Ra) have on the levels of inflammatory proteins in blood at days 14 and 21 days after a brain haemorrhage? Secondary question 3. What effect does the specific anti-inflammatory drug (IL-1Ra) have on recovery from brain haemorrhage? Secondary Objective 4. Confirmation that blood levels of the anti-inflammatory drug (IL-1Ra), when given twice daily remain consistently within the expected range. Secondary objective 5. Confirmation that the chosen method of administration (injection under skin, twice a day) is safe, feasible and well tolerated by patients following brain haemorrhage. | — |
Countries
United Kingdom
Outcome results
None listed