Table 6.
Published studies of invasive intracranial pressure monitoring in ALF
| Year of publication | Author | Single or multi-center | Number of patients | Type of invasive monitor used | Coagulopathy reversal strategy | Consistent use of a single protocol? | Post-procedure imaging required in all patients? | Incidence of intracranial hemorrhage | Incidence of elevated ICP |
|---|---|---|---|---|---|---|---|---|---|
| 1980 | Hanid et al. | Single-center | 10 | Subdural 100% | FFP 2 units during procedure | Yes | No | 14% | 100% |
| 1982 | Canalese et al. | Single- center clinical trial of mannitol and dexamethasone | 17 | Subdural and epidural | FFP during procedure | Yes | No | None reported | 82% |
| 1989 | Forbes et al. | Single-center clinical trial of thiopental in ALF | 13 | Epidural 100% | Not specified | N/A | No | None reported | 100% |
| 1991 | Munoz et al. | Single-center | 14 | Epidural 100% | FFP and plasma exchange to goal prothrombin time <16 seconds | Yes | No | None reported | 80% |
| 1992 | Lidofsky et al. | Single- center | 23 (20 adults, 3 children) | Subdural 91%; epidural 9% | FFP to goal prothrombin time within 3–5 seconds of control; fibrinogen goal 100 mg/dL; platelet transfusion to goal 75,000/μL | Yes | No | 22% (symptomatic 17%) | 43% |
| 1993 | Keays et al. | Single-center | 36 | Epidural 100% | None | N/A | No | 3% (symptomatic 0%) | 26% |
| 1993 | Blei et al. | Multi-center | 262 | Epidural 61%; subdural 30%; intraparenchymal 9% | Not specified | No | No | Overall 8% (fatal 4%); epidural 3% (fatal 1%); subdural 18% (fatal 5%); intraparenchymal 13% (fatal 4%) | Not evaluated |
| 2005 | Vaquero et al. | Multi-center (ALFSG) | 58 | Subdural 64%; intraparenchymal 21%; epidural 16% | FFP 91%; platelets 31%; rFVIIa 26%; cryoprecipitate 19%; plasmapheresis 5% | No | No | Overall 10% (symptomatic 5%); subdural 11% (symptomatic 8%); epidural 11% (symptomatic 11%), intraparenchymal 8% (symptomatic 0%) | Not reported |
| 2008 | Raschke et al. | Single-center | 22 | Intraparenchymal 100% | rFVIIa plus FFP to goal prothrombin time <16 seconds; platelet transfusion to goal >100,000/μL; fibrinogen goal 100 mg/dL; desmopressin 30 μg/kg IV × 1 | Yes | No | 3/17 (18%) overall | 95% |
| 2010 | Le et al. | Single- center | 11 | Intraparenchymal 100% | rFVIIa average dose 3 mg (36.7 μg/kg), monitor then placed within 2 hours without rechecking INR | Yes | Yes | None | None |
| 2012 | Kamat et al. | Single-center | 14 children | Intraparenchymal 100% | rFVIIa plus FFP within 30 mins prior to procedure to achieve INR ≤1.5; vitamin K | Yes | Not reported | Symptomatic 7% | Not reported |
| 2014 | Karvellas et al. | Multi-center (ALFSG) | 140 | Subdural 27%; intraparenchymal 24%; epidural 23%; lumbar 17%; external ventricular drain 9%; | FFP 84%; platelet transfusion 43%; rFVIIa 2% | No | No | Symptomatic 7% | 51% |
| 2016 | Maloney et al. | Single-center | 20 | Intraparenchymal 65%; epidural 35% | FFP and rFVIIa to goal INR ≤1.5; platelet transfusion to goal 50,000/μL | Not reported | No | Overall 15% reported. intraparenchymal - 2 of 10 (20%) with imaging available (both fatal); epidural 1 of 3 (33%) - with imaging available (asymptomatic) | 70% |
| 2016 | Bernal et al. | Multi-center clinical trial of hypothermia in ALF | 43 | Intraparenchymal 100% | Not reported | Not reported | No | None - one remote hemorrhage in the temporal lobe | 44% |
| Current study | Rajajee et al. | Single-center | 24 | Intraparenchymal 100% | See Table 1 | Yes | Yes | 4% (symptomatic 0%) | 54% |
List of studies of invasive intracranial pressure monitoring in acute liver failure (ALF). ALFSG Acute Liver Failure Study Group, FFP fresh frozen plasma, rFVIIa Recombinant factor VIIa, IV intravenous, INR international normalized ratio, N/A Not Applicable