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Documents

Here, you can find various REDUSE trial-related documents; click to download each document.

Protocol

  • Clinical Trial Protocol v1.2

CRF

  • Source Data Location Description     

  • Subject Enrollment and Identification

  • Access Instructions

  • CRF Instructions to Investigators

Follow-up

  • Data Sheet for REDUSE Follow-up

  • Patient Questionnaire (in Swedish)

  • Montreal Cognitive Assessment (MOCA; in Swedish)

  • Modified Fatigue Impact Scale (MFIS)

  • Glasgow Outcome Scale Extended (GOSE)

  • Life Satisfaction (in Swedish)

  • Health Questionnaire EQ-5D-5L (in English)

  • Health Questionnaire EQ-5D-5L (in Swedish)

Start-up

  • Checklist for start-up (in Swedish)

Ethics

  • Ethical approval (in Swedish)

  • Ethical approval - amendment 1 (in Swedish) 

  • Ethical approval - amendment 2 (in Swedish) 

  • Ethical approval - amendment 3 (in Swedish) 

Other files

  • Patient Information and Consent Form (in Swedish)

  • Intervention Protocol (in Swedish)

  • Algorithm for Non-resuscitation Fluids Intervention Arm

  • Local trial ledger

  • Patient ledger

 

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