Condition category
Injury, Occupational Diseases, Poisoning
Date applied
09/09/2008
Date assigned
24/11/2008
Last edited
11/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Peter Hutchinson

ORCID ID

Contact details

Level 4 A block
box 167
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IL1ra 02 v04

Study information

Scientific title

A single centre phase II study of interleukin-1 receptor antagonist in the treatment of severe traumatic brain injury

Acronym

Study hypothesis

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

Cambridge Local Research Ethics Committee 2 (LREC 2), June 2008, ref: 06/Q0108/64

Study design

Open label randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase II

Drug names

Interleukin-1 receptor antagonist

Primary outcome measures

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 trial start date

15/09/2008

Overall trial end date

15/09/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

26

Participant 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

Recruitment start date

15/09/2008

Recruitment end date

15/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Level 4 A block, box 167
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Research and Development
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Government

Website

http://www.addenbrookes.org.uk/

Funders

Funder type

Charity

Funder name

Academy of Medical Sciences (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24569690

Publication citations

Additional files

Editorial Notes

11/05/2016: Publication reference added.