Table 1 Basic characteristics of both trials
From: Pre-hospital plasma transfusion: a valuable coagulation support or an expensive fluid therapy?
| Â | COMBAT | PAMPer | ||
|---|---|---|---|---|
| Â | FFP | Standard | FFP | Standard |
Setting | US ground EMS transport (Denver) single-centre | US air EMS transport multicentre | ||
Randomisation | Individual randomisation by content of cooling boxes; staff non-blinded | Cluster randomisation at monthly intervals; staff non-blinded | ||
Inclusion criteria | BP < 70 mmHg or BP 71–90 mmHg + HR > 108/min | BP < 70 mmHg or BP < 90 mmHg and HR > 108/min | ||
Patients included (n) | 65 vs 60 | 230 vs 271 | ||
Age median (IQR) | 33 (25–51) | 33 (25–42) | 44 (31–59) | 46 (28–60) |
Male (%) | 80 | 85 | 71 | 74 |
Blunt injury (%) | 46 | 53 | 81 | 73 |
Injury severity Score median (IQR)* | 27 (10–41) | 27 (11–36) | 22 (14–33) | 21 (12–29) |
Prothrombin time ratio or INR on hospital arrival | 1.3 | 1.2 | 1.2 | 1.3 |
Pre-hospital management | ||||
 Pre-hospital intubation (%) | Not provided | Not provided | 50 | 50 |
 Pre-hospital RBCs (%) | Not provided | Not provided | 26 | 42 |
 Pre-hospital crystalloids (mls) median (IQR) | 150 (0–300) | 250 (100–500) | 500 (0–1250) | 900 (0–1500) |
 Tranexamic acid within 6 h (%) | 9 | 13 | Not provided | Not provided |
 Intervention | 2 U pre-thawed FFP up to 5d old FFP vs standard | 2 U apheresis FFP (approx. 500 ml) vs standard | ||
 Median Transportation time median (IQR) | 28 (22–34) min | 24 (19–31) min | 42 (34–53) min | 40 (33–41) min |
Outcome | ||||
 Primary endpoint | Mortality 28 days | Mortality 30 days | ||
 Mortality 28/30d (%) | 15 | 10 | 23 | 33 |
 Mortality 24 h (%) | 12 | 10 | 14 | 22 |