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Table 2 Outcome measures

From: Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial

Primary outcome measures:  
1. (A) Time to administration of fibrinogen administration (FC or Cryo) from time of ROTEM® analysis and clinical scenario suggesting that fibrinogen supplementation is required  
1. (B) Feasibility of administering FC within 30 min of ROTEM® and clinical scenario suggesting that fibrinogen supplementation is required  
2. Effects of fibrinogen supplementation (FC and Cryo) on fibrinogen levels as measured by FIBTEM and Clauss Fibrinogen (FibC)  
Secondary outcome measures:  
1. Transfusion requirements (in number of units) of PRBC, FFP, FC, Cryo, platelets, PCC at 4, 6, 12, 24 and 48 h  
2. Duration of bleeding episode or time until surgical haemorrhage control with no further coagulation factors  
3. Duration of mechanical ventilation  
4. Duration of ICU and hospital LOS  
5. ROTEM® (Sigma and Delta), Multiplate®, FBC, INR, APTT, FibC analysis at prespecified time points  
6. Evaluation of EXTEM CT in response to fibrinogen supplementation  
7. Adverse events: TACO, TRALI, Sepsis, MOF  
8. Thromboembolic complications  
9. All-cause mortality at 4, 6, 24 h and up to 90 days  
Feasibility outcome measures:  
1. Transfusion requirements (in number of units) of PRBC, FFP, FC, Cryo, Platelets, PCC at 4, 6, 12, 24 and 48 h  
2. Duration of bleeding episode or time until surgical haemorrhage control with no further coagulation factors  
3. Duration of mechanical ventilation  
4. Duration of ICU and hospital LOS  
5. ROTEM® (Sigma and Delta), Multiplate®, FBC, INR, APTT, FibC analysis at prespecified time points  
6. Evaluation of EXTEM CT in response to fibrinogen supplementation  
7. Adverse events: TACO, TRALI, Sepsis, MOF  
8. Thromboembolic complications  
9. All cause mortality at 4, 6, 24 h and up to 90 days  
Feasibility outcome measures:  
1. Time to randomisation  
2. FC and Cryo wastage  
3. Proportion of patients with blood sampling at all prespecified time points  
4. Number of missed patients (eligible but not enrolled)  
5. Randomisation errors  
6. Protocol violations  
  1. APTT Activated Partial Thromboplastin Time, Cryo cryoprecipitate EXTEM CT clotting time, FBC full blood count, FC fibrinogen concentrate, FFP fresh frozen plasma, FibC Clauss Fibrinogen, ICU intensive care unit, INR International Normalised ratio, LOS length of stay, MOF Multiple organ failure, PCC Prothrombin complex concentrate, PRBC packed red blood cells, ROTEM® thromboelastometry, TACO transfusion-associated circulatory overload, TRALI transfusion-related acute lung injury