Skip to main content

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

 PrehospitalHospital
 ALS team arrival on sceneAdmission at ICUFollow-up
Eligibility screenx  
Consentx x
Allocation to normal saline or FLYPx  
Treatment Administrationx  
Patients Demographicsx  
Clinical/physiological Dataxxx
Injury Severity Score x 
INR (point of care)xx 
INR (blood sample)xx 
Need for massive transfusion x 
ICU length of stay  x
Deathxxx
Serious adverse Eventsxxx
  1. ALS advanced life support, ICU intensive care unit, FLYP French lyophilised plasma, INR international normalized ratio