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The HyP-HIT Study
ISRCTN ISRCTN77393684
DOI 10.1186/ISRCTN77393684
ClinicalTrials.gov identifier
EudraCT number
Public title The HyP-HIT Study
Scientific title Hypothermia Paediatric Head Injury Trial
Acronym HyP-HIT
Serial number at source MCT-50398
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.
Lay summary
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.
Countries of recruitment Canada, France, United Kingdom
Disease/condition/study domain Paediatric traumatic brain injury
Participants - 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
Participants - 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
Anticipated start date 01/10/1998
Anticipated end date 31/10/2005
Status of trial Completed
Patient information material
Target number of participants 225
Interventions Group one: Hypothermia therapy, oesophageal temperature (32 - 33ºC)
Group two: Normothermia, oesophageal temperature (36.5 - 37.5ºC)
Duration: 24 hours
Primary outcome measure(s) Paediatric Cerebral Performance Category (PCPC) score, six months post head injury.
Secondary outcome measure(s) 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
Sources of funding 1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca/ (ref: MCT-50398)
2. Children’s Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)
3. Ontario Neurotrauma Foundation (Canada)
4. Hospital for Sick Children Foundation (Canada)
5. Physician’s Services Inc. (Canada)
6. Québec Health Research Fund (Fonds de la recherche en santé du Québec [FRSQ]) (Canada)
Trial website
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18525042
Contact name Dr  James S  Hutchison
  Address Department of Critical Care Medicine
Hospital for Sick Children
555 University Avenue
Toronto
  City/town Ontario
  Zip/Postcode M5G 1X8
  Country Canada
  Tel +1 416 813 5822
  Fax +1 416 813 7299
  Email jamie.hutchison@sickkids.ca
Sponsor Children’s Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)
  Address 401 Smyth Road
Ottawa
  City/town Ontario
  Zip/Postcode K1H 8L1
  Country Canada
  Tel +1 613 737 7600 ext 2686
  Fax +1 613 738 4869
  Email brazeau@cheo.on.ca
  Sponsor website: http://www.cheori.org/
Date applied 06/03/2007
Last edited 28/10/2010
Date ISRCTN assigned 06/03/2007
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