Table 1 The published studies included in the data synthesis
Study | Region | Study participants | Number of participants (male, female) | Age, (%) or Mean (SD) or median [25–75%IQR] | Intervention | Reported outcome of interest | Primary outcome of the original study | ISS |
|---|---|---|---|---|---|---|---|---|
Sabouri [35] | Iran | Isolated traumatic brain injury | 71 [54, 17] | No information | Calculated amounts of FC | Length of ICU stay, Length of hospital days | Mortality rate | Isolated head injury with on-admission GCS < 9 |
Lucena [34] | Brazil | Trauma | 32 [4, 28] | Placebo 40.2 (15.7) FC 44 (16.3) | 50 mg/kg of body weight | In-hospital mortality, Thrombosis events, Length of ICU stay, Length of hospital days | Feasibility of FC administration | ISS≧ 15 |
Ziegler [32] | International | Trauma | 53 [44, 9] | Placebo 54 [37–56] FC 46 [34.5–58] | 3 g of the study drug was given in patients with bodyweight 30 to 60 kg, 4.5 g in patients with bodyweight 60 to 90 kg and 6 g in patients with bodyweight 90 to 120 kg | The change in FIBTEM MCF on arrival at the ED, the need for volume and requirements for transfusion, thromboembolic complications | The change in FIBTEM MCF on arrival at the ED | Placebo 16 [16–34], FC 25 [16–36] |
Akbari [30] | Iran | Trauma | 60 [49, 11] | Placebo 18–39.9(76.7%), 40–59.9(13.3%), 60 ≤ (10.0%) FC 18–39.9(73.4%), 40–59.9(10%), 60 ≤ (16.6%) | 2 g of FC | In-hospital mortality, RBC transfusion 24 h, Thrombotic events, Multiple organ failure, Length of hospital day | Mortality | Placebo 19 ± 4.3 FC 19.3 ± 4.3 (mean ± SD) |
Curry [11] | UK | Trauma | 48 [39, 9] | Placebo 38.7 (12.6) FC 38.1 (26.8) | 6 g of FC | In-hospital mortality, RBC transfusion 24 h, FFP transfusion 24 h, PC transfusion 24 h | Feasibility | Placebo 29 [11, 22–33], FC 34 [24–43] |
Innerhofer [18] | Austria | Trauma | 94 [70, 24] | Placebo 40.0 (17.7) FC 40.7 (24.5) | 50 mg/kg of FC | In-hospital mortality, RBC transfusion 24 h, FFP transfusion 24 h, PC transfusion 24 h, Thrombotic events, Multiple organ failure, Length of ICU stay, Length of hospital day | Multiple organ failure | FFP 30 [24–45], FC 35 [29–42] |
Nascimento [33] | Canada | Trauma | 44 [8, 11] | Placebo 48 [19–78] FC 28 [19–88] | 6 g of FC | In-hospital mortality, RBC transfusion 24 h, FFP transfusion 24 h, PC transfusion 24 h, Thrombotic events | Feasibility | Placebo 23 [18–29], FC 25 [19–29] |
Collins [17] | UK | Postpartum haemorrahge | 55 [0, 55] | Placebo 30.8 [19–42] FC 33.5 [20–48] | FC dose was calculated according to Fibtem A5, ideal body wight for height | RBC transfusion 24 h, FFP transfusion 24 h, Bood loss within 24 h, Thrombotic events, Length of hospital day | The number of allogeneic blood products (RBC, FFP, cryoprecipitate, platelets) infused after study medication until hospital dishcarge | NA |
Wikkelso [31] | Denmark | Postpartum haemorrahge | 244 [0, 244] | No information | 2 g of FC | In-hospital mortality, Thrombotic events | RBC transfusion during a 6 week follow-up period postpartum | NA |