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Table 3 SPIRIT schedule with study process and data collection during study period

From: REBOARREST, resuscitative endovascular balloon occlusion of the aorta in non-traumatic out-of-hospital cardiac arrest: a study protocol for a randomised, parallel group, clinical multicentre trial

 

Study period

 

Enrolment

Randomisation

Post randomisation

Timepoint

-T

T = 0

Hospitalisation

T < week 2

T + 30 day

T + 1 year

Enrolment

      

Inclusion criteria

X

     

Exclusion criteria

X

     

Allocation

 

X

    

Informed consent

  

X

X

  

Interventions

      

Intervention or control group

 

X

    

Assessments

      

ROSC

 

X

    

Survival

 

X

X

X

X

X

Pre-hospital registrations

      

Utstein styled documentation

X

X

    

End-tidal CO2

 

X

    

REBOA-procedure related data

 

X

    

All relevant dispatch/procedure times

X

X

X

   

In-hospital registrations

      

Blood gas from admission

  

X

   

Blood sample analysis

  

X

X

  

Urine output

  

X

X

  

Complications related to REBOA

  

X

X

X

 

Cardiac interventions

  

X

X

X

 

Length of stay intensive care

  

X

X

X

 

Length of stay hospital

  

X

X

X

 

Length of invasive respiratory support

  

X

X

X

 

Length of renal replacement therapy

  

X

X

X

 

Modified Rankin scale

    

X

 

Adverse events

 

X

X

X

X

 
  1. SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; ROSC, return of spontaneous circulation; REBOA, resuscitative endovascular balloon occlusion of the aorta