From: Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial
Primary outcome measures: | Â |
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) | Â |
Secondary outcome measures: | Â |
1. Transfusion requirements (in number of units) of PRBC, FFP, FC, Cryo, platelets, PCC at 4, 6, 12, 24 and 48Â h | Â |
2. Duration of bleeding episode or time until surgical haemorrhage control with no further coagulation factors | Â |
3. Duration of mechanical ventilation | Â |
4. Duration of ICU and hospital LOS | Â |
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 | Â |
7. Adverse events: TACO, TRALI, Sepsis, MOF | Â |
8. Thromboembolic complications | Â |
9. All-cause mortality at 4, 6, 24Â h and up to 90Â days | Â |
Feasibility outcome measures: | Â |
1. Transfusion requirements (in number of units) of PRBC, FFP, FC, Cryo, Platelets, PCC at 4, 6, 12, 24 and 48Â h | Â |
2. Duration of bleeding episode or time until surgical haemorrhage control with no further coagulation factors | Â |
3. Duration of mechanical ventilation | Â |
4. Duration of ICU and hospital LOS | Â |
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 | Â |
7. Adverse events: TACO, TRALI, Sepsis, MOF | Â |
8. Thromboembolic complications | Â |
9. All cause mortality at 4, 6, 24Â h and up to 90Â days | Â |
Feasibility outcome measures: | Â |
1. Time to randomisation | Â |
2. FC and Cryo wastage | Â |
3. Proportion of patients with blood sampling at all prespecified time points | Â |
4. Number of missed patients (eligible but not enrolled) | Â |
5. Randomisation errors | Â |
6. Protocol violations | Â |