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Table 1 Assessments of randomised subjects

From: A pragmatic pilot phase II randomised controlled trial of prothrombin complex concentrates (PCC) versus fresh frozen plasma (FFP) in adult patients who are undergoing heart surgery (PROPHESY)

Study Procedure

Screening pre-operatively

Prior to surgery (time 0)

Prior to randomisation – intervention

1 h post-study intervention

24 h post-surgery

Days 7, 14, 21

Day 30 (discharge/death)

Day 90 (discharge/death)

Visit windows

− 14 days

Day 0

Day 0

Day 0

Day 1

+/− 1 day

+/− 2 days

+/− 7 days

Screening - assess eligibility (includes urine pregnancy test)

X

       

Informed consent

X

       

Patient characteristics

X

       

Assessment by surgical team

X

       

Assessment by anaesthesiologist

X

       

Blood testsa – FBC

X

 

X

X

X

   

Blood testsa - group and screen samples

X

X

      

Blood testsa – liver and renal function tests

X

   

X

   

Routine coagulation tests (PT, aPTT and fibrinogen)a

X

 

X

X

X

   

Additional clotting assaysb

  

X

X

X

   

Thromboelastographic assessmenta

  

X

X

X

   

Inform transfusion laboratory of need for FFP

  

X

     

Randomisation and intervention – PCC or octaplasLG /FFP

  

X

     

Time of intervention (start and stop)

  

X

     

Weekly ICU assessment

    

X

X

  

Thromboembolic AE/SAE

   

X

X

X

X

X

Transfusion AE/SAE

   

X

X

X

X

 

Hospital re-admission since discharge

       

X

Quality of life – EQ-5D

X

      

X

90-Day survival status - end of study form (telephone or clinic visit)

       

X

  1. Abbreviations: AE adverse events, aPTT activated partial thromboplastin time, EQ-5D EuroQol 5-dimension quality of life scale, FBC full blood count, FFP fresh frozen plasma, ICU intensive care unit, PCC prothrombin complex concentrate, PT prothrombin time, SAE serious adverse events