Table 1 Summary details of eligible randomised, controlled trials
Study | Indication | Study type | N patients (intervention group vs controls) | Intervention details | Control group |
|---|---|---|---|---|---|
FFP | |||||
Boyd et al. (1996) [108] | Surgery (renal transplantation; renal disease and coagulopathy) | RCT | 39 (19 vs 20) | FFP 2 U | Conjugated oestrogen 50 mg |
Chong Sung et al. (2006) [35] | CV surgery (paediatric) | RCT | 42 (21 vs 21) | FFP 10 ml/kg | HES (130/0.4) 10 ml/kg |
Consten et al. (1996) [36] | CV surgery | RCT | 50 (24 vs 26) | FFP 3 U | Plasma substitute 3 U |
Demeyere et al. (2010) [37] | CV surgery in patients on OAT | RCT | 40 (20 vs 18) | FFP 4 U (additional doses could be administered to reach target INR) | PCC calculated to target INR of 1.5 (additional doses could be administered to reach target INR) |
Etemadrezaie et al. (2007) [78] | Traumatic brain injury | RCT | 90 (44 vs 46) | FFP 10 to 15 ml/kg | Saline 10 to 15 ml/kg |
Haubelt et al. (2002) [38] | CV surgery | Block-RCT | 67 (31 vs 36) | FFP 600 ml | SD-FFP 600 ml |
Kasper et al. (2001) [41] | CV surgery | RCT | 56 (27 vs 29) | FFP 15 ml/kg | 6% HES (450/0.7) 15 ml/kg |
Laine et al. (2003) [64] | Liver transplantation | RCT | 33 (15 vs 18) | FFP median 14 U (+10 U RBC) | WB median 12 U |
Menges et al. (1992) [43] | Surgery (other) | RCT | 42 (16 vs 12/14) | (Autologous) FFP + blood (dose not reported) | Homologous RBC/autologous blood (dose not reported) |
Mintz et al. (2006) [65] | Liver transplantation | RCT | 51 (29 vs 22) | FFP 22.7 U over 7 days | PCT-FFP 21.3 U over 7 days |
Noddeland et al. (2002) [45] | CV surgery | RCT | 84 (55 vs 29) | SD-FFP (2:1 Uniplas:Octaplas) median 3 U Uniplas:2 U Octaplas | No FFP |
Trimble et al. (1964) [48] | CV surgery (adults, children) | RCT | 53 (21 vs 32) | FFP 2 U adults, 1 U children | No FFP |
von Sommoggy et al. (1990) [49] | Surgery (other) | RCT | 24 (13 vs 11) | FFP (+ human albumin) mean 2.7 U | HES (dose not reported) |
Wilhelmi et al. (2001) [50] | CV surgery | Block-RCT | 120 (60 vs 60) | FFP 4 U (1,000 ml) | HES 1,000 ml |
Williamson et al. (1999) [22] (duplicate data in [21]) | Surgery (liver) | RCT | 25 (13 vs 12) | FFP median 44 ml/kg | SD-FFP median 44 ml/kg |
Fibrinogen concentrate | |||||
Cui et al. (2010) [56] | CV surgery (children) | RCT | 31 (17 vs 14) | Fibrinogen concentrate 0.5 to 1.0 g | 'Standard allogeneic therapy' |
Fenger- Eriksen et al. (2009) [71] | Surgery (cystectomy) | RCT | 20 (10 vs 10) | Fibrinogen concentrate 45 mg/kg | Placebo (isotonic saline) 2.25 ml/kg |
Karlsson et al. (2009) [54] | CV surgery | RCT | 20 (10 vs 10) | Fibrinogen concentrate 2 g | No fibrinogen concentrate |