Introduction
Materials and methods
Study concept and administrative structure
Search criteria
Eligibility criteria
Data extraction
Analysis
Results
Studies included
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 |
Study | Indication | Study type | N(intervention group vs controls) | Intervention details | Control group |
---|---|---|---|---|---|
FFP | |||||
Antolovic et al. (2008) [75] | Surgery (ischaemic colitis) | Retrospective comparator | 81 (30 vs 51) | FFP ≥ 3 U | FFP < 3 U |
Apaydin et al. (2002) [76] | CV surgery | Retrospective comparator | 85 (16 vs 69) | FFP > 2 U | FFP ≤ 2 U |
Bochicchio et al. (2008) [77] | Trauma | Prospective comparator | 922 | FFP mean 5.4 U | No FFP |
Borgman et al. (2007) [34] | Massive trauma | Retrospective comparator | 246 | FFP:RBC high 1:1.4 | FFP:RBC 1:2.5 and 1:8 |
Chowdhury et al. (2004) [109] | Various | Prospective comparator | 22 (10 vs 12) | FFP standard dose median 12.2 ml/kg | FFP high dose median 33.5 ml/kg |
Dente et al. (2009) [30] | Massive trauma | Prospective cohort vs historical control | 157 (73 vs 84) | FFP:RBC ≥ 1:2 (MTP) | FFP:RBC < 1:2 (pre MTP) |
Duchesne et al. (2008/2009/2010) | Massive trauma, surgery (TIC), trauma | Retrospective comparator | 385/135/196 | FFP:RBC 1:1 | Ratios outside 1:1 |
Gunter (2008) et al. [28] | Massive trauma | Prospective cohort vs historical control | 259 (64 vs 195) | FFP:RBC 1:1 to 1:1.5 | FFP:RBC < 1:1.5 and > 1:1 |
Hildebrandt (2007) et al. [23] and Kerner et al. (2008) [24] | Surgery (craniofacial, infants) | Non RCT | 30 (15 vs 15) | FFP mean 45 ml/kg | 5% human albumin |
Holcomb et al. (2008) [3] | Massive trauma | Retrospective comparator | 466 | FFP:RBC ≥ 1:2 | FFP:RBC < 1:2 |
Inaba et al. (2010) [79] | Trauma (nonmassive transfusion) | Retrospective matched cohort | 568 (284 vs 284) | FFP mean 3.0 U | No FFP |
Johansson et al. (2007) [39] | CV surgery | Prospective cohort vs historical control | 148 (55 vs 93) | FFP:RBC 1:1 (transfusion package) mean 10 U | FFP:RBC < 1:1 (pre transfusion package) mean 7 U |
Johansson et al. (2009) [69] | Surgery (various) with massive transfusion | Prospective cohort vs historical control | 832 (442 vs 390) | FFP:RBC 1:1.3 (transfusion package) | FFP:RBC 1:1.6 (pre transfusion package) |
Kaibori et al. (2008) [40] | Surgery (hepatectomy for hepatocellular carcinoma) | Retrospective comparator | 184 (43 vs 141) | FFP median 4.0 U | No FFP |
Kashuk et al. (2008) [80] | Massive trauma | Retrospective comparator | 133 | FFP:RBC 1:1 | FFP:RBC 1:2, 1:3, 1:4 or 1:5 |
Koch et al. (2009) [105] | CV surgery | Retrospective matched cohort | 1928 (964 vs 964) | FFP, dose not reported | No FFP |
Maegele et al. (2008) [81] | Massive trauma | Retrospective comparator | 713 | FFP:RBC 1:1 | FFP:RBC < 0.9:1 and > 1.1:1 |
Massicotte et al. (2005) [82] | Liver transplantation | Retrospective comparator | 66 (26 vs 40) | FFP mean 4.9 U | No FFP |
Mell et al. (2010) [42] | CV surgery | Retrospective comparator | 128 (87 vs 41) | FFP:RBC ≥ 1:2 | FFP:RBC < 1:2 |
Miller et al. (1997) [44] | CV surgery (paediatric) | Prospective comparator | 36 (19 vs 17) | FFP, dose not reported | Cryoprecipitate, dose not reported |
Mitra et al. (2010) [66] | Massive trauma | Retrospective comparator | 331 | FFP:RBC > 1:1.5 | FFP:RBC < 1:1.5 |
Oberkofler et al. (2010) [83] | Liver transplantation | Retrospective comparator | 144 | FFP > 10 U | FFP < 10 U |
Ono et al. (2002) [84] | CV surgery | Retrospective comparator | 60 (39 vs 21) | FFP 3.2 U | No FFP |
Reed et al. (1986) [46] | Trauma | Prospective cohort vs published data | 40 (16 vs 24) | FFP 2 U/12 U blood | No FFP |
Riskin et al. (2009) [85] | Massive trauma | Retrospective comparator | 77 | FFP:RBC 1:1.8 (MTP) | FFP:RBC 1:1.8 (pre MTP) |
Rose et al. (2009) [86] | Massive trauma | Retrospective comparator | 204 | FFP:RBC 1:1 | FFP:RBC < 0.9:1 and > 1.1:1 |
Roy et al. (1988) [47] | CV surgery | Retrospective comparator (sequential cohorts) | 100 (52 vs 48) | FFP mean 5.8 U | 5% albumin |
Scalea et al. (2008) [87] | Trauma | Prospective comparator | 250 | FFP:RBC 1:1 | Ratios outside 1:1 |
Scheele et al. (2001) [88] | Surgery (liver resection for colorectal metastases) | Retrospective comparator | 425 (159 vs 308) | FFP, dose not reported | No FFP |
Shaz et al. (2010) [4] | Massive trauma | Retrospective comparator | 214 | FFP:RBC ≥ 1:2 | FFP:RBC < 1:2 |
Snyder et al. (2009) [89] | Massive trauma | Retrospective comparator | 134 (60 vs 74) | FFP:RBC ≥ 1:2 | FFP:RBC < 1:2 |
Sperry et al. (2008) [67] | Massive trauma | Retrospective comparator | 415 | FFP:RBC ≥ 1:1.5 | FFP:RBC < 1:1.5 |
Stinger et al. (2008) [90] | Massive trauma | Retrospective comparator | 252 | FFP high fibrinogen:RBC > 0.2 g fibrinogen/1 U RBC) | FFP low fibrinogen:RBC < 0.2 g fibrinogen/1 U RBC) |
Teixeira et al. (2009) [91] | Massive trauma | Retrospective comparator | 383 | FFP:RBC > 1:2 | FFP:RBC < 1:8, 1:8 to 1:3 and 1:3 to 1:2 |
Tomimaru et al. (2010) [92] | Surgery (hepatectomy for hepatocellular carcinoma) | Retrospective comparator | 497 (204 vs 293) | FFP median 10 U | No FFP (in 93% of patients in the group) |
Wright et al. (2008) [93] | CV surgery | Retrospective comparator | 211 (129 vs 82) | FFP (mixed donors) median 6 U | FFP (male-only donors) median 4 U |
Zink et al. (2009) [68] | Massive trauma | Retrospective comparator | 466 | FFP:RBC ≥ 1:1 | FFP:RBC < 1:1 |
Fibrinogen concentrate | |||||
Rahe-Meyer et al. (2009) [55] | CV surgery | Non RCT | 15 (10 vs 5) | Fibrinogen concentrate mean 5.7 g | FFP mean 4.2 U |
Rahe-Meyer et al. (2009) [26] | CV surgery | Prospective cohort vs historical control | 18 (6 vs 12) | Fibrinogen concentrate mean 7.2 g | FFP mean 9.1 U |
Study | Indication | Study type | Patients (N) | Intervention details | Control group |
---|---|---|---|---|---|
FFP | |||||
Aiyagari et al. (2005) [51] | Trauma (gunshot injury) | Case report | 3 | FFP 10 U, 4 U, 8 U | No control group |
Dann et al. (2008) [110] | Massive trauma | Retrospective noncomparator | 21 | FFP:RBC 1:1.5 | No control group |
Díaz-Gómez et al. (2010) [94] | CV surgery | Retrospective noncomparator | 14,868 | FFP | No control group |
Fan et al. (2003) [95] | Liver transplantation | Prospective noncomparator | 100 | FFP | No control group |
Fischer et al. (2008) [52] | GI bleeding (preterms) | Retrospective noncomparator | 5 | FFP 10 to 30 ml/kg/30 minutes | No control group |
Gonzalez et al. (2007) [96] | Massive trauma | Retrospective noncomparator | 97 | FFP mean 5 U | No control group |
Lei et al. (2009) [106] | CV surgery | Retrospective noncomparator | 298 | FFP mean 1,090 ml | No control group |
Magner et al. (2007) [111] | Liver transplantation | Case report | 2 | SD-FFP 42 U, 16 U | No control group |
Moore et al. (2008) [97] | Massive trauma | Prospective noncomparator | 93 | FFP 6.3 U | No control group |
Pull ter Gunne et al. (2010) [107] | Surgery (other) | Retrospective noncomparator | 300 | FFP mean 2.61 U | No control group |
Ranucci et al. (2008) [98] | CV surgery | Retrospective noncomparator | 4546 | FFP | No control group |
Schols et al. (2008) [53] | Surgery (CV, abdominal or spinal bone) | Prospective noncomparator | 51 | FFP mean 780 ml | No control group |
Spinella et al. (2008) [99] | Trauma | Retrospective noncomparator | 708 | FFP mean 3 U | No control group |
Stricker et al. (2010) [70] | Surgery (other, paediatric) | Retrospective noncomparator | 159 | FFP mean 20 ml/kg | No control group |
Swisher et al. (1996) [100] | Surgery (oesophageal resection for cancer) | Retrospective noncomparator | 275 | FFP | No control group |
Tenza et al. (2009) [101] | Liver transplantation | Retrospective noncomparator | 74 | FFP mean 15.7 U | No control group |
Watson et al. (2009) [103] | Trauma | Retrospective noncomparator | 842 | FFP median 4.8 U | No control group |
Wiederkehr et al. (2010) [102] | Liver transplantation | Retrospective noncomparator | 155 | FFP | No control group |
Fibrinogen concentrate | |||||
Bell et al. (2010) [112] | Postpartum haemorrhage | Case series | 6 | Fibrinogen concentrate | No control group |
Böhrer (1999) [57] | Liver transplantation | Case report | 1 | Fibrinogen concentrate 2 g | No control group |
Brenni et al. (2010) [58] | Trauma | Case report | 1 | Fibrinogen concentrate 16 g | No control group |
Farriols Danés et al. (2008) [104] | Various | Retrospective noncomparator | 69 | Fibrinogen concentrate median 4 g | No control group |
Fenger-Eriksen et al. (2008) [59] | Severe bleeding | Retrospective noncomparator | 43 | Fibrinogen concentrate mean 2.0 g | No control group |
Glover et al. (2010) [63] | Postpartum haemorrhage | Case report | 1 | Fibrinogen concentrate | No control group |
Haas et al. (2008) [113] | Surgery (craniofacial, paediatric) | Case series | 9 | Fibrinogen concentrate median 76 mg/kg | No control group |
Heindl et al. (2005) [116] | Surgery (other) | Case report | 2 | Fibrinogen concentrate 7 g, 8 g | No control group |
Innerhofer (2006) [60] | Surgery (lumbar) | Case report | 1 | Fibrinogen concentrate 5 g | No control group |
Peitsidou et al. (2008) [114] | Emergency caesarean section and Hysterectomy | Case report | 1 | Fibrinogen concentrate 2 g | No control group |
Schöchl et al. (2010) [61] | Massive trauma, then laparotomy | Case report | 1 | Fibrinogen concentrate 13 g | No control group |
Schöchl et al. (2010) [62] | Trauma surgery | Case report | 1 | Fibrinogen concentrate 12 g | No control group |
Schöchl et al. (2010) [73] | Trauma surgery | Retrospective noncomparator | 128 | Fibrinogen concentrate median 7 g | No control group |
Solomon et al. (2010) [72] | CV surgery | Retrospective noncomparator | 39 | Fibrinogen concentrate mean 6.5 g | No control group |
Thorarinsdottir et al. (2010) [74] | Surgery (various) | Retrospective noncomparator | 37 | Fibrinogen concentrate median 2 g | No control group |
Weinkove et al. (2008) [115] | Various | Retrospective noncomparator | 30 | Fibrinogen concentrate median 4 g | No control group |
Other | |||||
Murad et al. (2010) [5] | Various | Meta-analysis | 12,421 | FFP | Various |
Study types and interventions | FFP, n(%) | Fibrinogen concentrate, n(%) | ||
---|---|---|---|---|
Study type | N = 70 | N = 21 | ||
RCT | 15 (21.4%) | 3 (14.3%) | ||
Comparator study | 37 (52.9%) | 2 (9.5%) | ||
Noncomparator study | 18 (25.7%) | 16 (76.2%) | ||
Comparison group intervention | N = 52 | N = 5 | ||
Colloid, crystalloid or no intervention | 20 (38%) | 2 (40%) | ||
Alternative dosage or formulation | 32 (62%) | 0 (0%) | ||
Fibrinogen concentrate vs FFP | Included in adjacent column | 3 (60%) | ||
Meta-analysis | N = 1 | N = 0 |
Articles and studies excluded because of overlapping and duplicate data
Blood loss
Fresh frozen plasma
FFP outcomes: blood loss | Fibrinogen concentrate outcomes: blood loss | |||||
---|---|---|---|---|---|---|
Study type | Reduction | No difference | Increase | Reduction | No difference | Increase |
RCT | - | - | 1 (postoperative) [54] | 1 (postoperative) [56] | - | |
Non RCT or prospective comparator | - | 1 (postoperative) [44] | 1 (postoperative) [55] | - | - | |
Retrospective comparator | 1 (perioperative) [34] | 1 (perioperative) [42] | - | 1 (postoperative) [26] | - | - |
Controlled and/or comparator study outcomes, n (percentage of all outcomes within intervention group) | 1 (5%) | 18 (90%) | 1 (5%) | 3 (75%) | 1 (25%) | 0 |
Prospective noncomparator | - | 1 (postoperative) [53] | - | - | - | - |
Retrospective noncomparator | - | 1 (postoperative) [52] | - | 1 (perioperative) [59] | - | - |
Case report | - | 1 (perioperative) [51] | - | - | - | |
Study outcomes, n (percentage of outcomes within intervention group) | 1 (4%) | 21 (92%) | 1 (4%) | 10 (91%) | 1 (9%) | 0 |
Fibrinogen concentrate
Allogeneic transfusion requirements
Fresh frozen plasma
FFP outcomes: allogeneic transfusions | Fibrinogen concentrate outcomes: allogeneic transfusions | |||||
---|---|---|---|---|---|---|
Type of study | Reduction | No difference | Increase | Reduction | No difference | Increase |
RCT | - | 1 (postoperative) [54] | - | |||
Non RCT or prospective comparator | - | 1 (intraoperative) [23] 1 (postoperative) [23] | 1 (postoperative) [44] | 1 (postoperative) [55] | - | - |
Retrospective comparator | 1 (postoperative) [39] 1 > 24 hours postoperative) [30] | 1 (postoperative) [47] | - | 1 (intraoperative) [26] 1 (postoperative) [26] | - | - |
Controlled and/or comparator study outcomes, n (percentage of all outcomes within intervention group) | 5 (23%) | 14 (63%) | 3 (14%) | 5 (63%) | 3 (37%) | 0 |
Prospective noncomparator | - | 1 (postoperative) [53] | - | - | - | - |
Retrospective noncomparator | 1 (postoperative) [70] | - | - | 1 (perioperative) [73] | - | - |
Case report | - | - | - | - | - | |
Study outcomes (percentage of outcomes, n (within intervention group) | 6 (25%) | 15 (63%) | 3 (12%) | 16 (84%) | 3 (16%) | 0 |
Fibrinogen concentrate
Survival
Fresh frozen plasma
FFP outcomes: survival | Fibrinogen concentrate outcomes: survival | |||||
---|---|---|---|---|---|---|
Type of study | Improvement | No difference | Reduction | Improvement | No difference | Reduction |
RCT | - | - | 1 (1 to 32 days) [38] 1 (in-hospital) [78] | - | - | - |
Non RCT or prospective comparator | - | 1 (in-hospital) [87] | 1 (in-hospital) [77] | - |
-
| - |
Retrospective comparator | 1 (90 days) [69] | 1 (36 months) [40] | 1 (30 days) [92] 1 (1 year) [82] 1 (10 years) [88] | - | 1 (30 days) [26] | - |
Controlled and/or comparator study outcomes, n (percentage of all outcomes within intervention group) | 20 (50%) | 12 (30%) | 8 (20%) | 0 | 1 (100%) | 0 |
Prospective noncomparator | 1 (24 hours) [97] | - | 1 (in-hospital) [95] | - | - | - |
Retrospective noncomparator | 1 (6 months) [101] 1 (1 year) [102] 1 (68 months) [100] | 1 (at 6 months) [101] | 1 (7 days) [104] 1 (in-hospital) [73] | - | - | |
Case report | - | - | - | - | - | - |
Study outcomes, n (percentage of outcomes within intervention group) | 23 (44%) | 17 (33%) | 12 (23%) | 2 (67%) | 1 (33%) | 0 |
Fibrinogen concentrate
Length of stay
Fresh frozen plasma
FFP outcomes: ICU and/or hospital length of stay | Fibrinogen concentrate outcomes: ICU and/or hospital length of stay | |||||
---|---|---|---|---|---|---|
Type of study | Reduced | No difference | Increased | Reduced | No difference | Increased |
RCT | - | 1 (ICU) [50] | - | 1 (ICU) [56] 1 (hospital) [56] | - | - |
Non RCT or prospective comparator | 1 (hospital) [24] | 1 (hospital) [87] | 1 (ICU) [77] 1 (hospital) [77] | 1 (ICU) [55] | 1 (hospital) [55] | - |
Retrospective comparator | 5 (hospital) | 1 (ICU) [26] | 1 (hospital) [26] | - | ||
Controlled and/or comparator study outcomes, n (percentage of all outcomes within intervention group) | 2 (8%) | 11 (44%) | 12 (48%) | 4 (67%) | 2 (33%) | 0 |
Prospective noncomparator | - | - | - | - | - | - |
Retrospective noncomparator | - | 1 (ICU) [107] 1 (hospital) [107] | - | - | - | |
Case report | - | - | - | - | - | - |
Study outcomes, n (percentage of outcomes within intervention group) | 2 (7%) | 13 (45%) | 14 (48%) | 4 (67%) | 2 (33%) | 0 |
Fibrinogen concentrate
Plasma fibrinogen levels
Fresh frozen plasma
FFP outcomes: plasma fibrinogen levels | Fibrinogen concentrate outcomes: plasma fibrinogen levels | |||||
---|---|---|---|---|---|---|
Type of study | Increased/higher | No difference | Decreased/lower | Increased/higher | No difference | Decreased/lower |
RCT | 1 (vs comparator) [41] | 1 (vs preadministration) [108] | - | - | ||
Non RCT or prospective comparator | 1 (vs comparator) [23] | 1 (vs preadministration/comparator) [109] | 1 (vs comparator) [44] | 1 (vs comparator) [55] | - | - |
Retrospective comparator | 1 (vs comparator) [30] | - | - | 1 (vs comparator) [26] | - | - |
Controlled and/or comparator study outcomes, n (percentage of outcomes within intervention group) | 5 (46%) | 4 (36%) | 2 (18%) | 4 (100%) | 0 | 0 |
Prospective noncomparator | 1 (vs preadministration) [53] | - | - | - | - | - |
Retrospective noncomparator | 1 (vs preadministration) [70] | - | 1 (vs preadministration) [110] | - | - | |
Case report | - | - | - | - | ||
Study outcomes, n (percentage of outcomes within intervention group) | 7 (44%) | 4 (25%) | 5 (31%) | 17 (100%) | 0 | 0 |
Fibrinogen concentrate
Discussion
Quality of evidence
Potential for bias
Efficacy outcomes
Risk versus benefit
Patients, N | Adverse events*^, n(%) | |||||
---|---|---|---|---|---|---|
Study type | Indication | Fibrinogen concentrate | Comparator | Fibrinogen concentrate | Comparator | Details |
RCTs | ||||||
Cui et al. (2010) [56] | CV surgery (children) | 17 | 14 | - | - | Adverse events not reported |
Fenger-Eriksen et al. (2009) [71] | Surgery (cystectomy) | 10 | 10 | 0 | 0 | |
Karlsson et al. (2009) [54] | CV surgery | 10 | 10 | 0 | 1 (10%) | 1 perioperative myocardial infarction (comparator group) |
Trials with a comparator group | ||||||
Rahe-Meyer et al. (2009) [55] | CV surgery | 10 | 5 | 1 (10%) | 1 (20%) | 2 postoperative atrial fibrillation (1 fibrinogen concentrate group, 1 comparator group) |
Rahe-Meyer et al. (2009) [26] | CV surgery | 6 | 12 | 0 | 5 (42%) | 1 postoperative atrial fibrillation (comparator group) 2 renal failure (2 comparator group) 2 major neurological events (2 comparator group) |
Totals (comparator trials reporting adverse events) | 36 | 37 | 1 (3%) | 7 (19%) | ||
Noncomparator trials and case reports | ||||||
Bell et al. (2010) [112] | Postpartum haemorrhage | 6 | - | 0 | - | |
Böhrer et al. (1999) [57] | Liver transplantation | 1 | - | 0 | - | |
Brenni et al. (2010) [58] | Trauma | 1 | - | 0 | - | |
Farriols Danés et al. (2008) [104] | Various | 69 | - | 0 | - | |
Fenger-Eriksen et al. (2008) [59] | Severe bleeding | 43 | - | 2 (5%) | - | 1 jitter and snoring respiration 1 shivering (causal relationship to fibrinogen concentrate administration could not be excluded in either case) |
Glover et al. (2010) [63] | Postpartum haemorrhage | 1 | - | 0 | - | |
Haas et al. (2008) [113] | Surgery (craniofacial, paediatric) | 9 | - | 0 | - | |
Heindl et al. (2005) [116] | Surgery (other) | 2 | - | 1 | - | 1 acute renal failure (case 1) |
Innerhofer (2006) [60] | Surgery (lumbar) | 1 | - | 0 | - | |
Peitsidou et al. (2008) [114] | Emergency caesarean section and hysterectomy | 1 | - | - | - | Adverse events not reported |
Schöchl et al. (2010) [61] | Massive trauma, then laparotomy | 1 | - | 0 | - | |
Schöchl et al. (2010) [62] | Trauma surgery | 1 | - | - | - | Adverse events not reported |
Schöchl et al. (2010) [73] | Trauma surgery | 128 | - | - | - | Adverse events not reported |
Solomon et al. (2010) [72] | CV surgery | 39 | - | 0 | - | |
Thorarinsdottir et al. (2010) [74] | Surgery (various) | 37 | - | 0 | - | |
Weinkove et al. (2008) [115] | Various | 30 | - | 4 (13%) | - | 4 arterial ischaemic events (median 7.5 days (range 4 to 12 days) following fibrinogen concentrate administration) |
Totals (noncomparator trials and case reports reporting adverse events) | 240 | - | 7 (3%) | - |
Fresh frozen plasma and fibrinogen concentrate during surgery and massive trauma
Conclusions
Key messages
-
◆ There is a relative paucity of high-quality prospective studies reporting the outcome of FFP administration in a perioperative or massive trauma setting, despite having been in use for many years.
-
◆ There is inconsistent and contradictory evidence concerning the efficacy of FFP. No single outcome has shown a benefit of FFP in > 50% of extracted measures.
-
◆ The use of fibrinogen concentrate as a haemostatic intervention in the management of perioperative bleeding is still in its early years, which is reflected by the low number of published studies that we identified.
-
◆ Evidence for the efficacy of fibrinogen concentrate was consistent, with no negative outcome reported for any measure.
-
◆ There appears to be some promise in the use of fibrinogen concentrate instead of FFP for the treatment of acquired bleeding, although there is insufficient evidence currently available in the literature to draw any definitive conclusions. More high-quality prospective studies are needed, particularly studies directly comparing fibrinogen concentrate with FFP.