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Table 6 Published studies of invasive intracranial pressure monitoring in ALF

From: Protocol based invasive intracranial pressure monitoring in acute liver failure: feasibility, safety and impact on management

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%

  1. 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