Interleukin-1 receptor antagonist in severe traumatic brain injury
| ISRCTN | ISRCTN88597330 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88597330 |
| Secondary identifying numbers | IL1ra 02 v04 |
- Submission date
- 09/09/2008
- Registration date
- 24/11/2008
- Last edited
- 11/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Peter Hutchinson
Scientific
Scientific
Level 4 A block, box 167
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Study information
| Study design | Open label randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A single centre phase II study of interleukin-1 receptor antagonist in the treatment of severe traumatic brain injury |
| Study objectives | Interleukin-1 receptor antagonist (IL-1ra) is safe, will cross the blood brain barrier and attenuate the cerebral inflammatory response to traumatic brain injury. |
| Ethics approval(s) | Cambridge Local Research Ethics Committee 2 (LREC 2), June 2008, ref: 06/Q0108/64 |
| Health condition(s) or problem(s) studied | Traumatic brain injury |
| Intervention | Participants are randomised to receive 5 days of 100 mg IL-1ra (Kineret) subcutaneously once a day or a placebo. Clinical follow-up at 6 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Interleukin-1 receptor antagonist |
| Primary outcome measure | Safety: based on adverse events, follow-up assessment of outcome at 6 months. |
| Secondary outcome measures | 1. IL-1ra, IL-1alpha, IL-1beta, IL-6, IL-8 in serum and by cerebral microdialysis, measured by 4-hourly serum markers twice daily 2. Cerebral lactate, pyruvate, glucose, glutamate, glycerol by cerebral microdialysis, measured by 4-hourly serum markers twice daily 3. Clinical follow-up at 6 months, Glasgow Outcome Scale (GOS) and 36-item Short Form Health Survey (SF-36) |
| Overall study start date | 15/09/2008 |
| Completion date | 15/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 26 |
| Key inclusion criteria | 1. Severe traumatic brain injury 2. Aged 16 - 65 years, either sex 3. Abnormal computed tomography (CT) scan requiring sedation, paralysis, ventilation and multi-modality monitoring as part of clinical care |
| Key exclusion criteria | 1. Head injury unlikely to survive 5 days, e.g. bilaterally fixed dilated pupils 2. Follow up not possible 3. Not suitable for insertion of cranial access device, e.g. bleeding diathesis 4. Immunosuppression 5. Severe renal insufficiency 6. Pregnancy/nursing mothers 7. Known hypersensitivity to E. Coli derived products 8. Adminstration of live vaccine |
| Date of first enrolment | 15/09/2008 |
| Date of final enrolment | 15/09/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Level 4 A block, box 167
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Website | http://www.addenbrookes.org.uk/ |
|---|---|
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Charity
Academy of Medical Sciences (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Academy of Medical Sciences
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2014 | Yes | No |
Editorial Notes
11/05/2016: Publication reference added.
