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23 May 2012
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| [ Print-friendly version ] |
| The HyP-HIT Study |
| ISRCTN | ISRCTN77393684 |
| ClinicalTrials.gov identifier | |
| 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
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| 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 |
| 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 |
| 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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| © 2012 ISRCTN unless otherwise stated. | |
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