Table 1.
Study | Design | Treatment (no. of patients) | Major findings |
Cardiovascular surgery | |||
Rahe-Meyer et al. [8▪] | RCT | Fibrinogen concentrate (n = 29) | Fibrinogen concentrate controls coagulopathic bleeding during aortic surgery more effectively than placebo or a standardized treatment algorithm (4 units FFP or 2 units apheresis platelets) |
FFP/PLT (n = 32) | Fibrinogen concentrate also provides a more rapid and at least as effective control of intraoperative bleeding compared with standardized treatment (post-hoc analysis of data [18]) | ||
Plasma fibrinogen and FIBTEM MCF were corrected by fibrinogen concentrate or fibrinogen concentrate + FFP | |||
Fibrinogen concentrate raises plasma fibrinogen more effectively than FFP, as it allows targeting of a high normal level | |||
The increases were short-lived; plasma fibrinogen and FIBTEM MCF were comparable in all groups by 24 h postsurgery | |||
Tanaka et al. [15] | Prospective, randomized open-label study | Fibrinogen concentrate (n = 10) | Despite moderately decreased thrombin generation, bleeding was reduced with a single dose of 4-g fibrinogen concentrate to reach a target fibrinogen level of 2 g/l |
PLT (n = 10) | |||
Trauma | |||
Khan et al. [19] | Prospective cohort study | 4 U PRBCs up to 12 U | Hemostatic resuscitation does not correct hypoperfusion or coagulopathy during the acute phase of trauma hemorrhage |
Innerhofer et al. [20] | Post hoc analysis of data from a prospective study | Coagulation factor concentrates (fibrinogen concentrate and/or PCC; n = 66) | Coagulation factor concentrates alone corrected coagulopathy in patients with severe blunt trauma |
Coagulation factor concentrates (fibrinogen concentrate and/or PCC) + FFP (n = 78) | |||
Postpartum hemorrhage | |||
Collins et al. [21▪] | Prospective, observational study | n = 356 | Fibrin-based clot formation is a rapidly available early biomarker for progression of postpartum hemorrhage |
Mallaiah et al. [10▪] | Prospective two-phase study | Phase 1: n = 42 | Fibrinogen concentrate allows prompt correction of coagulation deficits associated with major obstetric hemorrhage |
Phase 2: n = 51 |
FFP, fresh frozen plasma; MCF, maximum clot firmness; PCC, prothrombin complex concentrate; PLT, platelet; PRBCs, packed red blood cells; RCT, randomized controlled trial.