Protocol, consent, randomisation and data collection:

Data collection proforma (pdf)

RESCUEicp study protocol, version 4 December 2009 (pdf)

How to recruit a patient - flowchart guide (pdf)

Consent form (pdf)

Information for relatives (pdf)

Randomisation fax sheet (pdf)

Eligibility Screening Log (pdf) - Please not that all centres are now required to keep a screening log.

 

Reporting Adverse Events (AE) and Serious Adverse Events (SAE):

Please use the following guidance and form to report all major events involving patients in the study:

Guidance on reporting Serious Adverse Events

Serious Adverse Events form

 

Outcome assessment:

The following questionnaires should be used for assessment of patients' outcome at 6 months, 1 year and 2 years after the injury. They can be printed or filled in as a digital form (this will require Adobe Reader 7.0 or higher, which is available for free download.

For patients over 16 years of age please use the adult version of the form:
Glasgow Outcome Scale (Extended) and SF-36™ questionnaire (pdf)

For children under the age of 16 years please use the form below:
Glasgow Outcome Scale (Extended) and SF-10™ questionnaire (pdf)

Please post or email forms to Liz Corteen.

 

Ethical approval and study agreements (indemnity):

All participating centres are required to obtain ethical committee and instituional R&D / IRB approval prior to commencing the recruitment of patients. Please contact the RESCUEicp Researh Sister - Ms Liz Corteen for further details on the process.

Documents translated into other languages:

  russian   Протокол исследования RESCUEicp                          Информация для родственников

  czech   RESCUEicp Protokol                                                      Informace Pro Příbuzné Pacientů

  italian  SF-36v2

  Spanish Protocolo de investigación      Cómo reclutar a un paciente   Criterios de Inclusión/Exclusión

               Folleto informativo para los familiares de los pacientes          Formulario de consentimiento informado

               Cuestionario de seguimiento de resultados del estudio           Registro de elegibilidad para el estudio

  Brazil  Estudo RESCUEicp           Critérios de Inclusão-Exclusão         Como recrutar um paciente

  Portugal  Ficha de informacao para as familias dos pacientes             Formulario de consentimento informado
                               

                Formulario de Avaliacao do estado final do paciente para o estudo

 

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Documents relevant to the study

Randomised Evaluation of Surgery with Craniectomy for
Uncontrollable Elevation of Intra-Cranial Pressure