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 |