The HyP-HIT Study

ISRCTN	ISRCTN77393684
DOI	https://doi.org/10.1186/ISRCTN77393684
Secondary identifying numbers	MCT-50398

Submission date: 06/03/2007
Registration date: 06/03/2007
Last edited: 28/10/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr James S Hutchison
Scientific

Department of Critical Care Medicine
Hospital for Sick Children
555 University Avenue
Toronto
Ontario
M5G 1X8
Canada

Phone	+1 416 813 5822
Email	jamie.hutchison@sickkids.ca

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Hypothermia Paediatric Head Injury Trial
Study acronym	HyP-HIT
Study objectives	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(s)	Approval received from the Research Ethics Committee of Children's Hospital of Eastern Ontario on the 26th October 1998.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/1998
Completion date	31/10/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	17 Years
Sex	Both
Target number of participants	225
Key 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
Key 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
Date of first enrolment	01/10/1998
Date of final enrolment	31/10/2005

Locations

Countries of recruitment

Canada
France
United Kingdom

Study participating centre

Department of Critical Care Medicine

Ontario
M5G 1X8
Canada

Sponsor information

Childrens Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)
Hospital/treatment centre

401 Smyth Road
Ottawa
Ontario
K1H 8L1
Canada

Phone	+1 613 737 7600 ext 2686
Email	brazeau@cheo.on.ca
Website	http://www.cheori.org/
"ROR"	https://ror.org/05nsbhw27

Funders

Funder type

Research organisation

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

No information available

Childrens Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)

No information available

Ontario Neurotrauma Foundation (Canada)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Fondation ontarienne de neurotraumatologie, ONF
Location: Canada

Hospital for Sick Children Foundation (Canada)

No information available

Physicians Services Inc. (Canada)

No information available

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

No information available

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	05/06/2008		Yes	No