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Table 1 Template for the schedule of enrolment, interventions, and assessments per the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials) [26]

From: French lyophilized plasma versus normal saline for post-traumatic coagulopathy prevention and correction: PREHO-PLYO protocol for a multicenter randomized controlled clinical trial

 

Prehospital

Hospital

 

ALS team arrival on scene

Admission at ICU

Follow-up

Eligibility screen

x

  

Consent

x

 

x

Allocation to normal saline or FLYP

x

  

Treatment Administration

x

  

Patients Demographics

x

  

Clinical/physiological Data

x

x

x

Injury Severity Score

 

x

 

INR (point of care)

x

x

 

INR (blood sample)

x

x

 

Need for massive transfusion

 

x

 

ICU length of stay

  

x

Death

x

x

x

Serious adverse Events

x

x

x

  1. ALS advanced life support, ICU intensive care unit, FLYP French lyophilised plasma, INR international normalized ratio