Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr James S Hutchison

ORCID ID

Contact details

Department of Critical Care Medicine
Hospital for Sick Children
555 University Avenue
Toronto
Ontario
M5G 1X8
Canada
+1 416 813 5822
jamie.hutchison@sickkids.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-50398

Study information

Scientific title

Hypothermia Paediatric Head Injury Trial

Acronym

HyP-HIT

Study hypothesis

Hypothermia therapy will improve long term (neurological, functional and cognitive) outcomes following traumatic brain injury in children.

Please note that this trial was submitted for an ISRCTN in September 2005 but was not assigned at the time due to incomplete data.

Ethics approval

Approval received from the Research Ethics Committee of Children's Hospital of Eastern Ontario on the 26th October 1998.

Study design

Multicentre, international, randomised, two arm, therapeutic management strategy trial, with outcome assessor and data-analyst blinding.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Paediatric traumatic brain injury

Intervention

Group one: Hypothermia therapy, oesophageal temperature (32 - 33ºC)
Group two: Normothermia, oesophageal temperature (36.5 - 37.5ºC)
Duration: 24 hours

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Paediatric Cerebral Performance Category (PCPC) score, six months post head injury.

Secondary outcome measures

1. The proportion of children achieving independent function, measured at one, three and 12 months post-head injury
2. Paediatric Injury Functional Outcome Score (IFOS), King's outcome score for childhood head injury, Glasgow Outcome Scale (GOS), GOS-expanded for children and adolescents, measured at one, three and 12 months post-head injury
3. Intelligence quotient, memory, speed of processing and attention, distractibility and behavioural rating scores, measured at three and 12 months post-head injury
4. Measures of cerebral physiology, complication rates and lengths of intensive care unit and hospital stay, during acute hospital stay

Overall trial start date

01/10/1998

Overall trial end date

31/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Informed consent by a parent or legal guardian
2. Aged one year up to and including 17 years, either sex, with diagnosis of traumatic brain injury
3. Have a Glasgow Coma Score less than or equal to eight (severe traumatic brain injury according to the recent guidelines assessed at the tertiary level paediatric hospital
4. With a Computed Tomography (CT) scan showing intra-cranial haemorrhage, diffuse axonal injury or cerebral oedema
5. Who are mechanically ventilated

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

225

Participant exclusion criteria

1. Who are in refractory shock defined as a hypotension despite intravenous colloid and red cell transfusions exceeding 80 cc/kg
2. With a suspected diagnosis of clinical brain death as defined as fixed and dilated pupils, Glasgow Coma Scale of three and no evidence of brain function on neurological examination
3. Who remain pulseless after arrival in the emergency department despite advanced cardiac life support including at least one dose of epinephrine
4. With high cervical (C1 to C5) cord injury
5. With a severe neurodevelopmental disability (Paediatric Cerebral Performance Category scores (see primary outcome) prior to head injury
6. Who have head injury secondary to a penetrating injury (e.g. gunshot wound)
7. Who have an acute epidural haematoma and are expected to recover rapidly following surgical evacuation of the haematoma
8. Who are randomised (and initiation of cooling for patients randomised to hypothermia) more than eight hours following the estimated time of injury
9. Who are pregnant (diagnosed by serum Human Chorionic Gonadotropin [HCG])
10. Whose parents/legal guardian refuse consent

Recruitment start date

01/10/1998

Recruitment end date

31/10/2005

Locations

Countries of recruitment

Canada, France, United Kingdom

Trial participating centre

Department of Critical Care Medicine
Ontario
M5G 1X8
Canada

Sponsor information

Organisation

Children’s Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)

Sponsor details

401 Smyth Road
Ottawa
Ontario
K1H 8L1
Canada
+1 613 737 7600 ext 2686
brazeau@cheo.on.ca

Sponsor type

Hospital/treatment centre

Website

http://www.cheori.org/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca/ (ref: MCT-50398)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Children’s Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ontario Neurotrauma Foundation (Canada)

Alternative name(s)

ONF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Canada

Funder name

Hospital for Sick Children Foundation (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Physician’s Services Inc. (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Québec Health Research Fund (Fonds de la recherche en santé du Québec [FRSQ]) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18525042

Publication citations

  1. Results

    Hutchison JS, Ward RE, Lacroix J, Hébert PC, Barnes MA, Bohn DJ, Dirks PB, Doucette S, Fergusson D, Gottesman R, Joffe AR, Kirpalani HM, Meyer PG, Morris KP, Moher D, Singh RN, Skippen PW, , Hypothermia therapy after traumatic brain injury in children., N. Engl. J. Med., 2008, 358, 23, 2447-2456, doi: 10.1056/NEJMoa0706930.

Editorial Notes