Table 15.2 Hypothermia for the Acute Management of Intracranial Pressure Post ABI
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Author Year Country Research Design PEDro Sample Size |
Methods | Outcomes |
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Andrews et al. (2015) UK Eurotherm3235 RCT PEDro=9 Ninitial=387 Nfinal=376 |
Population: TBI; Treatment Group (TG, n=195): Mean Age=37.4 yr; Time Post Injury: <12 hr=19, >12 hr=176; GCS: 1-2=56, 3-6=139. Control Group (CG, n=192): Mean Age=36.7 yr; Time Post Injury: <12hr=15, >12 hr=177; GCS: 1-2=51, 3-6=141. Intervention: Participants were randomly assigned to receive therapeutic hypothermia (TG) or standard care (CG). Hypothermia involved reducing body temperature to 32-35°C for >48 hr using intravenous cold fluid infusion. Outcomes were assessed at 6mo, and physiological measures were monitored 0-7 days. Outcome Measures: Glasgow Outcome Scale Extended (GOSE), Modified Oxford Handicap Scale (MOHS), Length of Stay (LOS), Mortality, Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Mean Arterial Pressure (MAP). |
1. Good outcomes (GOSE>4) occurred in 25.7% of TG and 36.5% of CG (p=0.03) at 6mo. 2. Adjusted odds for a poor outcome (GOSE<4) at 6 mo were significant (OR=1.69, p=0.03). 3. Adjusted common odds for GOSE score at 6 mo were significant (OR=1.53, p=0.04). 4. Mortality at 6 mo was higher in the hypothermia group compared to control [1.45 (1.01-2.10), p=0.05). 5. There was no significant difference between groups in LOS in ICU (MD=0.05, p=0.54) or MOHS grade at 28 d (OR=1.65, p=0.10). 6. There was no significant difference between groups in ICP (MD=-0.48, p=0.55), MAP (MD=1.20, p=0.16), or CPP (MD=1.61, p=0.11) over 1-7 d. |
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Maekawa et al. (2015) Japan BHYPO RCT PEDro=7 N=150 |
Population: TBI; Treatment Group (TG, n=99): Mean Age=39 yr; Gender: Male=69, Female=30; Median Time Post Injury=0.7 hr; Mean GCS=5.8. Control Group (CG, n=51): Mean Age=39 yr; Gender: Male=34, Female=17; Median Time Post Injury=0.8 hr; Mean GCS=5.9. Intervention: Participants were randomly assigned to receive therapeutic hypothermia (32-34° C, TG) or fever control (35-37° C, CG) for >72 hr. Temperature was lowered using intravenous cold fluid infusion, cooling blankets, and/or cold gastric lavage. Outcomes were assessed at 6mo, and physiological measures were monitored 0-7 days. Outcome Measures: Glasgow Outcome Scale (GOS), Mortality, Core Body Temperature (Tc), Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Mean Arterial Pressure (MAP), Central Venous Pressure (CVP). |
1. The rates of poor outcomes (GOS<4) were 53% in the TG and 48% in the CG. 2. There was no significant difference between groups in likelihood of poor outcome (RR=1.24, p=0.597) or mortality (RR=1.82, p=0.180). 3. TC was significantly lower in the TG at 0 days (p=0.002), 1 day (p<0.001), and 3 days (p<0.001) than in the CG. 4. There were no significant differences between groups in ICP, CPP, MAP, or CVP at any time point. |
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Suehiro et al. (2015) Japan BHYPO Post Hoc Analysis N=135 |
Population: TBI; Treatment Group (TG, n=88): Mean Age=41 yr; Gender: Male=59, Female=29; Mean GCS=5.7. Control Group (CG, n=47): Mean Age=38yr; Gender: Male=31, Female=16; Mean GCS=5.9. Intervention: Subset of participants from the Maekawa et al. (2015) were analyzed according to CT classification: diffuse I (n=2), diffuse II (n=40), diffuse III (n=22), diffuse IV (n=4), evacuated mass lesion (n=62), non-evacuated mass lesion (n=3), and unknown (n=2). Outcome Measures: Glasgow Outcome Scale (GOS), Mortality, Intracranial Pressure (ICP), Mean Arterial Pressure (MAP). |
1. In diffuse injury III, the rate of mortality was significantly higher in the TG than in the CG (54% versus 11%, p=0.041). 2. In each injury group, all other differences in rates of good outcome and mortality between conditions were not significant. 3. In diffuse injury II, ICP was significantly lower in the TG at 1 day (p=0.016) and MAP was significantly lower in the TG at 3 days (p=0.04). |
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Zhao et al. (2011) China RCT PEDro=6 N=81 |
Population: TBI; Treatment Group (TG, n=40): Mean Age=36.9 yr; Gender: Male=29, Female=11; GCS: 3-5=15, 6-8=25. Control Group (CG, n=41): Mean Age=37.5yr; Gender: Male=30, Female=11; GCS: 3-5=16, 6-8=25. Intervention: Participants were randomly assigned to receive hypothermia (33°C, TG) or normothermia (37°C, CG) for >72 hr. Temperature was lowered using a semiconductor blanket. Outcomes were assessed at 3mo and physiological measures were monitored during treatment. Outcome Measures: Glasgow Outcome Scale (GOS), Intracranial Pressure (ICP). |
1. Good outcome (GOS>4) was significantly higher in the TG than in the CG (75% versus 51%, p=0.038). 2. Death was higher in the CG than in the TG (10% versus 3%) but the difference was not significant (p>0.05). 3. After adjusting for age, GCS, and ICP, hypothermia was an independent predictor of good outcome (RR=4.9, p<0.05). 4. Mean ICP was significantly lower in the TG than in the CG at 24 hr (p<0.01) and 72 hr (p<0.01) after treatment. |
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Harris et al. (2009) USA RCT PEDro=7 N=25 |
Population: TBI; Mean Age=35.4 yr; Gender: Male=22, Female=3; Median Time Post Injury=6.0 hr; GCS: 5-8=7, 3-4=18. Intervention: Participants were randomized to receive localized hypothermia treatment (33°C, treatment) via a cooling cap or normothermia (control) for 24 hr. Outcomes were assessed during treatment. Outcome Measures: Intracranial Pressure (ICP), Temperature, Glasgow Outcome Scale (GOS), Functional Independence Measure (FIM). |
1. After the first 3 hr of treatment, the mean intracranial temperature was significantly lower in the treatment group than in the control group (p<0.05), but not at 4 and 6 hr (p=0.08); the target temperature was rarely achieved. 2. There were no significant differences between groups on GOS or FIM. |
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Qiu et al. (2007) China RCT PEDro=7 N=80 |
Population: TBI; Treatment Group (TG, n=40): Mean Age=41.3 yr; Gender: Male=27, Female=13; Mean Time Post Injury=6 hr; GCS: <6=23, >6=17. Control Group (CG, n=40): Mean Age=40.2 yr; Gender: Male=25, Female=15; Mean Time Post Injury=6 hr; GCS: <6=24, >6=16. Intervention: Patients were randomized to receive hypothermia (33-35°C, TG) or normothermia (CG) for 4 days. Outcomes were assessed before and after treatment. Outcome Measures: Intracranial Pressure (ICP), Serum Superoxide Dismutase (SOD), Neurological Outcomes, Complications. |
1. Mean ICP of the TG at 24, 48 and 72 hr was significantly lower than the CG. (p<0.001, p<0.001, p<0.05 respectively). 2. Mean SOD levels were significantly higher at 3 days and 7 days in the TG (p=0.000). 3. Percentage of favourable neurological outcomes at 1 yr was significantly higher in the TG than the CG (70% versus 47.5%; p=0.041). 4. Pulmonary infection and thrombocytopenia, were significantly higher in the TG than the CG ( p=0.025, p=0.044 respectively. All other complications were not significantly different between groups. |
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Smrcka et al. (2005) Czech Republic RCT PEDro=6 N=72 |
Population: TBI; Mean Age=41 yr; Gender: Male=51, Female=21; Mean GCS=4. Intervention: Participants were randomized to receive hypothermia (34°C, n=35) or normothermia (n=37). Hypothermia was delivered for 72 hr via cooling blankets. Outcomes were assessed before, after treatment, and at 6 mo follow-up. Outcome Measures: Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Glasgow Outcome Scale (GOS). |
1. Mean ICP was significantly lower in the hypothermia group than the normothermia group after treatment (11.77 mmHg versus 17.65 mmHg, p<0.0001). 2. Mean CPP was significantly higher in the hypothermia group than the normothermia group after treatment (78.23 mmHg versus 72.16 mmHg, p<0.0001). 3. GOS at 6 mo was significantly higher in the hypothermia group than in the normothermia group (4.09 versus 3.19, p=0.0131). |
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Zhi et al. (2003) China RCT PEDro=6 N=396 |
Population: TBI; Mean Age=42 yr; Gender: Male=291, Female=105; Time Post Injury<24 hr; Mean GCS=6. Intervention: Participants were randomized to receive hypothermia (32-35°C; n=198) or normothermia (36-37°C; n=198). Hypothermia was delivered for 1-7 days via cooling blankets. Outcomes were assessed at baseline, 1 day, 3 days, 7 days, and 6 mo. Outcome Measures: Intracranial Pressure (ICP), Glasgow Outcome Scale (GOS). |
1. Mean ICP was significantly reduced after hypothermia when compared to normothermia within 24 hr (21.4mmHg versus 25.5 mmHg, p<0.05), at 3 days (14.8mmHg versus 22 mmHg, p<0.05), and 7 days (14 mmHg versus 20.6 mmHg, p<0.05). 2. On the GOS at 6 mo, the hypothermia group had a significantly higher rate of good outcome (GOS=5; 39% versus 20%, p<0.05) and a significantly lower rate of death (26% versus 36%, p<0.05) when compared to the normothermia group. |
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Clifton et al. (2001) USA NABISH I RCT PEDro=6 N=392 |
Population: TBI; Treatment Group (TG, n=199): Mean Age=31 yr; Time Post Injury<6 hr; Mean GCS=5.6. Control Group (CG, n=193): Mean Age=32 yr; Time Post Injury<6 hr; Mean GCS=5.8. Intervention: Participants were randomly assigned to receive therapeutic hypothermia (33°C, TG) or normothermia (37°C, CG) for >48 hr. Temperature was lowered using ice, gastric lavage, and/or cool ventilation. Outcomes were assessed at 6 mo, and physiological measures were monitored 0-4 days. Outcome Measures: Glasgow Outcome Scale (GOS), Mortality, Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Mean Arterial Pressure (MAP), Therapy Intensity Level (TIL). |
1. There was no significant difference between groups in terms of poor outcome (RR=1.0, p=0.99) or mortality (RR=1.0, p=0.79). 2. There was no significant difference between groups in ICP at any time point. 3. CPP was significantly higher in the TG group at 1 day (p=0.003) and significantly lower in the TG at 3 days (p=0.003) and 4 days (p=0.01). 4. MAP was significantly lower in the CG group at 1 day (p=0.003) and significantly higher in the CG at 3 day (p<0.001) and 4 day (p<0.001). 5. TIL was significantly higher in the TG at 3 day (p=0.005). 6. TG has significantly higher rate of hospital days with complications than CG (78% versus 70%, p=0.005). |
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(2012) USA NABISH I & II Post Hoc Analysis N=489 |
Population: Trial 1: Treatment Group (TG, n=199): Mean Age=31 yr; Time Post Injury <6 hr; Mean GCS=5.6. Control Group (CG, n=193): Mean Age=32 yr; Time Post Injury<6 hr; Mean GCS=5.8. Trial 2: TBI; Treatment Group (TG, n=52): Mean Age=26 yr; Time Post Injury<2.5 hr; GCS: 3-4=19, 5-8=33. Control Group (CG, n=45): Mean Age=31 yr; Time Post Injury<2.5 hr; GCS: 3-4=23, 5-8=22. Intervention: Participants from Clifton et al. (2001a, 2011) were analyzed and pooled for meta-analysis. Outcome Measures: Glasgow Outcome Scale (GOS), Intracranial Pressure (ICP), Cerebral Perfussion Pressure (CPP), Mean Arterial Blood Pressure (MABP) |
1. Trial 2: In participants with hematomas removed, the rate/likelihood of poor outcome was significantly higher in the CG than the TG (69% versus 33%; RR=0.44; p=0.02). All participants in the latter group reached 35°C in <1.5 hr and 33°C in <5.5 hr. 2. Trial 1: In participants with hematomas removed, the rate of poor outcome was 45% of the TG reaching 35°C in <1.5 hr (n=31), 61% in of the TG reaching 35°C in >1.5 hr (n=23), and 60% in the CG (n=35); these differences were not significant (RR=0.74, p=0.16). 3. Trials 1+2: In participants with hematomas removed, the rate of poor outcome was significantly lower in those treated with early hypothermia (35°C in <1.5 hr) than those treated with late hypothermia (35°C in >1.5 hr) or normothermia (41% versus 62%, p<0.009). 4. In Trial 1 the percentage of patients with critically high ICP (>30 mmHg) was significantly lower in the hypothermia group versus the controls (p=0.04). In trial 2 however, no significant differences were found between the groups. 5. No significant differences were found between the hypothermia and normothermia groups regarding the incidence of criticall CPP (<60 mmHg) or MABP (<70 mmHg) in either trial. |
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Lee et al. (2010) China RCT PEDro=6 N=45 |
Population: TBI; Treatment Group 1 (TG1, n=15): Mean Age=44.0 yr; Gender: Male=9, Female=6; Mean GCS=6.4. Treatment Group 2 (TG2, n=14): Mean Age=38.8 yr; Gender: Male=8, Female=6; Mean GCS=6.5. Control Group (CG, n=16): Mean Age=43.5 yr; Gender: Male=10, Female=6; Mean GCS=6.4. Intervention: Participants were randomized to receive guided normothermia (CG), ICP/CPP-managed hypothermia (TG1), or hypothermia and brain tissue oxygen management (TG2). Outcomes were assessed before and after treatment. Outcome Measures: Intracranial Pressure (ICP), Glasgow Outcome Scale (GOS) Scores, Mortality. |
1. ICP values progressively increased in the first 3d but showed smaller changes and were significantly lower in TG1 and TG2 than CG at the same time points (p<0.05). 2. Favourable outcomes (GOS=4 & 5) were noted in 50% of the CG, 60% of TG1 and 71.4% of TG2. 3. Mortality was highest in the CG (12.5%) while it was 6.7% in TG1 and 8.5% in TG2; there was no statistical significance between groups (p>0.05). |
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Jiang et al. (2006) China RCT PEDro=6 N=215 |
Population: TBI; Mean Age=33 yr; Gender: Male=167, Female=48; Mean Time Post Injury=3 hr; GCS Range<8. Intervention: Participants received hypothermia (33-35°C) for short term (2 d, n=107) or long term (5 d, n=108) via cooling blankets. Outcomes were assessed during treatment and at 6 mo follow-up. Outcome Measures: Intracranial Pressure (ICP), Glasgow Outcome Scale (GOS), Complications. |
1. ICP significantly decreased in both groups after treatment (p<0.05). 2. ICP after 2 days was significantly higher in the short term group than in the long term group (p<0.05). 3. Rate of favourable outcome at 6 mo (GOS=4-5) was significantly higher in the long term group than in the short term group (43.5% versus 29.0%, p<0.05). 4. There was no significant difference between groups in rates of complications. |
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(2006) China RCT PEDro=5 N=66 |
Population: TBI; Mean Age=40.6 yr; Gender: Male=42, Female=24; GCS: 3-5=37, 6-8=29. Intervention: Participants were randomized to receive selective brain cooling (SBC, n=22), mild systemic hypothermia (MSH, n=21), or conventional treatment (control, n=23). SBC consisted of cooling the head and neck to 33-35°C using a cooling cap and neckband with circulating 4°C water. MSH was achieved using a cooling blanket and refrigerated ice bags to achieve a rectal temperature of 33-35°C. Both hypothermia treatments lasted for up to 6hr/d for 3 days. Outcomes were assessed before and after treatment. Outcome Measures: Intracranial Pressure (ICP), Serum Superoxide Dismutase (SOD), Glasgow Outcome Scale (GOS). |
1. Both hypothermia groups showed a significant decrease in ICP levels relative to the control group at 24, 48 and 72 hr post injury (p<0.05). 2. SOD levels were significantly higher in the hypothermia groups at 3 days and 7 days post injury (p<0.01). 3. The percentage of patients with good GOS scores 2 yr post injury were 72.7%, 57.1% and 34.8% in the SBC, MSH and control groups respectively. |
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(2001) Japan RCT PEDro=6 N=91 |
Population: TBI; Treatment Group (TG, n=45): Mean Age=35 yr; Gender: Male=35, Female=10; Mean GCS=5.5. Control Group (CG, n=46): Mean Age=42yr; Gender: Male=31, Female=15; Mean GCS=5.1. Intervention: Participants were randomized to receive hypothermia (34°C, TG) or normothermia (37°C, CG). Hypothermia was delivered for 48hr via cooling blankets and nasogastric lavage with iced saline. Outcomes were assessed at baseline, after treatment, and at 3 mo follow-up. Outcome Measures: Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Glasgow Outcome Scale (GOS), Therapeutic Intensity Level (TIL), Complications. |
1. There was no significant difference between groups in control of ICP and CPP after treatments. 2. On the GOS, there was no significant difference between TG and CG in rates of favourable outcome (GOS=4-5; 47% versus 57%), unfavourable outcome (GOS=2-3; 36% versus 28%), or death (GOS=1; 18% versus 13%). 3. For TIL, the TG had a significantly higher rate of neuromuscular blocking agents than the CG (63% versus 35%, p<0.011); the rates of other treatments were similar. 4. The TG had significantly higher rates of several complications than the CG, including pneumonia (49% versus 15%, p=0.001) and meningitis (28% versus 10%, p=0.039). |
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Jiang et al. (2000) China RCT PEDro=6 N=87 |
Population: TBI; Treatment Group (TG, n=43): Mean Age=42.2yr; Gender: Male=35, Female=8; Mean GCS=5.0. Control Group (CG, n=44): Mean Age=40.6; Gender: Male=37, Female=7; Mean GCS=5.1. Intervention: Participants were exposed to prolonged mild hypothermia (33-35°C, TG) or normothermia (37-38°C, CG) for 3-14d. Outcomes were assessed before and after treatment. Outcome Measures: Mortality, Glasgow Outcome Scale (GOS), Intracranial Pressure (ICP). |
1. Mortality rate was significantly lower in the TG than the CG (25.58% versus 45.45%, p<0.05). 2. Rate of favourable outcome on GOS was significantly higher in the TG than the CG (46.51% versus 27.27%, p<0.05). 3. Hypothermia caused a significant reduction in ICP (p<0.01) and inhibited hyperglycemia (p<0.05). |
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(1997) USA RCT PEDro=5 N=82 |
Population: TBI; Treatment Group (TG, n=40): Mean Age=31yr; Gender: Male=36, Female=4; Mean Time Post Injury=10hr; GCS: 3-4=18, 5-7=22. Control Group (CG, n=42): Mean Age=35yr; Gender: Male=33, Female=9; Mean Time Post Injury=10hr; GCS: 3-4=16, 5-7=26. Intervention: Participants were randomized to receive hypothermia for 24 hr (33°C) or normothermia for 5 days (37-39°C). Hypothermia was achieved using cooling blankets and cold saline gastric lavage. Outcomes were assessed before and after treatment. Outcome Measures: Glasgow Outcome Scale (GOS), Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Heart Rate (HR), Cerebral Blood Flow (CBF). |
1. The TG had significantly more patients with favorable outcome on the GOS compared to the CG at both 3 mo (38% versus 17%, p=0.03), and 12 mo (62% versus 38%, p=0.05). 2. Participants with GCS=3-4 did not benefit from hypothermia, whereas those with scores of 5-7 did. 3. Among participants with GCS=5-7, significantly more patients in the TG had a favorable GOS outcome at 6mo than those in the CG (73% versus 35%, p=0.008). 4. During the cooling period, the TG had significantly lower ICP (p=0.01), CBF (p=0.05), HR (p<0.001) and higher CPP (p=0.05) compared with CG. |
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Marion et al. (1993) USA RCT PEDro=6 N=40 |
Population: TBI; Treatment Group (TG, n=20): Mean Age=31.9 yr; Gender: Male=17, Female=3; Time Post Injury<6 hr; Mean GCS=5.3. Control Group (CG, n=20): Mean Age=32.1 yr; Gender: Male=17, Female=3; Time Post Injury<6 hr; Mean GCS=4.7. Intervention: Participants were randomized to receive hypothermia for 24 hr (32-33°C, TG) or normothermia for 5 days (37-38°C, CG). Hypothermia was achieved using cold saline gastric lavage and cooling blankets. Outcomes were assessed before and after treatment. Outcome Measures: Intracranial Pressure (ICP), Cerebral Blood Flow (CBF), Cerebral Metabolic Rate for Oxygen (CMRO2), Glasgow Outcome Scale (GOS). |
1. ICP (p=0.004) and CBF (p=0.021) were significantly lower in the TG than CG during cooling. 2. CMRO2 in the TG was significantly lower during cooling and higher at 5 days compared with the CG (p<0.001). 3. There was a trend toward a better outcome on GOS at 3 mo post injury in the TG than the CG (60% versus 40%, p=0.24). |
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Shiozaki et al. (1993) Japan RCT PEDro=5 N=33 |
Population: TBI; Treatment Group (TG, n=16): Mean Age=35.3 yr; Gender: Male=6, Female=10; GCS Range<8. Control Group (CG, n=17): Mean Age=35.4 yr; Gender: Male=10, Female=7; GCS Range<8. Intervention: Participants were randomized to receive hypothermia for 2 days (33.5-34.5°C, TG) or normothermia (CG). Outcomes were assessed before and after treatment. Outcome Measures: Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Glasgow Outcome Scale (GOS). |
1. In the TG, hypothermia significantly reduced ICP (p<0.01) and increased CPP (p<0.01). 2. Fifty percent of the patients in the TG survived compared with only 18% in the CG (p<0.05), while 31% in the TG and 71% in the CG died from uncontrollable ICP (p<0.05). 3. Thirty-eight percent of the TG had good GOS outcome at 6mo compared with only 6% of the CG. |
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Sun et al. (2016) China Pre-Post N=62 |
Population: TBI; Mean Age=36.8 yr; Gender: Male=37, Female=25; Mean GCS=5.20. Intervention: Patients were treated using mild hypothermia alone or mild hypothermia combined with conventional intracranial pressure (ICP) procedures. Outcome Measures: Intracranial Pressure (ICP), Brain Tissue Oxygenation (PbtO2), Jugular Venous Oxygen Saturation (SjvO2), Cranial Perfusion Pressure (CPP), End-Tidal Carbon Dioxide Pressure (ETCO2). |
1. Within 24 hr of hypothermia treatment ICP declined and PbtO2, SjvO2, and CPP increased significantly (all p<0.05). 2. Mild hypothermia combined with a 25 g dose of mannitol caused a significant reduction in ICP after 30 min (p<0.05), but rebounced at 90 min. However, the group treated with 50 g mannitol remained stable at 90 min (p<0.05). 3. For the patients that were still invalid after mannitol treatment, endotracheal intubation was performed, and they were treated with mechanically assisted aeration. The drop in ICP was significantly greater for the 25-29 mmHg ETCO2 group compared with the 30-34 mmHg ETCO2 group (p<0.05). 4. For the 26 patients that still remained invalid, a decompressive craniectomy in combination with mild hypothermia was performed. In these patients, ICP decreased significantly (p<0.05). |
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Flynn et al. (2015) UK Pre-Post N=17 |
Population: TBI; Treatment Group (TG, n=9): Mean Age=41yr; Gender: Male=7, Female=2; Time Post Injury<72 hr; Median GCS=7. Control Group (CG, n=8): Mean Age=34yr; Gender: Male=8, Female=0; Time Post Injury<72 hr; Median GCS=7. Intervention: Participants were randomly assigned to receive therapeutic hypothermia (TG) or standard care (CG). Hypothermia involved reducing body temperature to 32-35°C for at least 48 hr using intravenous cold fluid infusion. Outcomes were assessed at baseline and for the first 6hr of treatment. Outcome Measure: Intracranial Pressure (ICP). |
1. In the TG, mean ICP significantly decreased from baseline to 1hr (4.3 mmHg, p<0.04) and was maintained up to 6hr; there was a significant main effect of time (F=6.13, p<0.01). 2. In the CG, there was no significant change in ICP over the 6 hr and no significant main effect of time (p>0.05). 3. The difference between groups for change in ICP over the 6 hr was statistically significant; there was a significant group x time interaction (F=4, p<0.02). |
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Sahuquillo et al. (2009) Spain Pre-Post N=24 |
Population: TBI; Median Age=25 yr; Gender: Male=17, Female=7; Median Time Post Injury=72 hr; Median GCS=7. Intervention: Participants received hypothermia (32.5°C) for up to 14 days via cooling blankets and catheter. Outcome Measures: Intracranial Pressure (ICP), Glasgow Outcome Scale (GOS), Complications. |
1. Median ICP was significantly reduced from 23.8 mmHg at baseline to 16 mmHg after treatment (U=45.0, p<0.001). 2. At 6 mo, 37.5% of participants died (GOS=1), 25% had GOS=3, 8.3% had GOS=4, and 29.2 % had GOS=5. 3. The incidence of pneumonia was 50%. |
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(2009) Japan PCT N=61 |
Population: ABI. Treatment Group 1 (TG1, n=30): Mean Age=45 yr; Gender: Male=21, Female=9; Mean Time Post Injury=2.6 hr; Mean GCS=4.3.Treatment Group 2 (TG2, n=31): Mean Age=40 yr; Gender: Male=26, Female=5; Mean Time Post Injury=3.1 hr; Mean GCS=4.2. Intervention: Participants received hypothermia at 35°C (TG1) or at 33°C (TG2). Outcome Measures: Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Mortality, Complications. |
1. Both groups exhibited decreases in ICP below 20 mmHg with no differences in the incidence of intracranial hypertension or low CPP. 2. Patients in TG1 showed a trend toward decreased mortality and fewer complications. |
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(2006) China Cohort N=90 |
Population: TBI; Treatment Group (TG, n=45): Mean Age=40.1 yr; Gender: Male=29, Female=16; GCS Range≤8. Control Group (CG, n=45): Mean Age=41.8 yr; Gender: Male=30, Female=15; GCS Range≤8. Intervention: Participants received selective brain cooling (TG) or normothermia (CG). Cooling was achieved using a cooling cap and neck band for 3d. Outcome Measures: Intracranial Pressure (ICP), Glasgow Outcome Score (GOS). |
1. At 24, 48 and 72 hr ICP was significantly lower in the TG than the CG (19.14 versus 23.41, 19.72 versus 20.97 and 17.29 versus 20.13 mmHg respectively (p<0.01). 2. There was also significant difference in GOS at 6 mo between TG and CG (68.7% versus 46.7%, p<0.05). |
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Hayashi et al. (2005) Japan PCT N=41 |
Population: TBI; Treatment Group (TG, n=20): Mean Age=28.9 yr; Mean GCS=5. Control Group (CG, n=21): Mean Age=33.6 yr; Mean GCS=4.7. Intervention: Participants received either hypothermia (32-36°C, TG) or normothermia (CG). Hypothermia was delivered for 72-84 hr via cooling blankets and nasogastric lavage with iced saline. Outcomes were assessed before and after treatment, and at 6 mo follow-up. Outcome Measure: Glasgow Outcome Scale (GOS). |
1. The TG had a higher rate of favourable outcome (GOS=4-5) than the CG (55% versus 25%). 2. The TG had lower rates of unfavourable outcome (GOS=2-3; 10% versus 20%) and death (35% versus 60%) than the CG. 3. Within the TG, those who received very mild hypothermia (35-36°C, n=10) had a higher rate of favourable outcome (80% versus 30%) than those who received mild hypothermia (32-34°C, n=10). 4. Those who received very mild hypothermia had a lower rate of complications than those who received mild hypothermia (30% versus 0%). |
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Tokutomi et al. (2003) Japan Case Series N=31 |
Population: TBI; Mean Age=39.5 yr; Gender: Male=26, Female=5; GCS Range≤5. Intervention: Participants received hypothermia induced by surface cooling with water-circulating blankets. Outcome Measures: Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP). |
1. Incidence of elevated ICP decreased significantly with hypothermia (p<0.0001). 2. ICP decreased significantly at brain temperatures <37°C and decreased more sharply at 35-36°C, but no differences were observed at temperatures <35°C (p<0.05). 3. CPP peaked at 35-36°C and decreased with further decreases in temperature. |
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Gal et al. (2002) Czech Republic PCT N=30 |
Population: TBI; Treatment Group (TG, n=15): Mean Age=35 yr; Gender: Male=9, Female=6; Mean GCS=4.5. Control Group (CG, n=15): Mean Age=39 yr; Gender: Male=10, Female=5; Mean GCS=4.3. Intervention: Participants received hypothermia (34°C, TG) or normothermia (36.5-37.5°C) for 72 hr. Hypothermia was achieved using forced air cooling combined with circulating water mattress cooling. Outcome Measures: Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), Glasgow Outcome Score (GOS). |
1. There was a significant reduction in ICP in the TG compared with the CG (p=0.0007). 2. There was a significant increase in CPP (p=0.0007) with unchanged (p=0.90) systolic arterial pressure values in the TG compared with CG. 3. No significant differences between groups in GOS outcome 6 mo (p=0.084) although 87% of patients in the TG reached good neurological recovery (GOS 4-5) compared with only 47% in the CG. |
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Polderman et al. (2002) Netherlands PCT N=136 |
Population: TBI; Treatment Group (TG, n=64): Mean Age=39.2 yr; GCS Range≤8. Control Group (CG; n=72): Mean Age=34.2 yr; GCS Range≤8. Intervention: Participants were treated with moderate hypothermia (32-34ºC) using water-circulating blankets (TG) or conventional treatment (CG). Outcome Measures: Intracranial Pressure (ICP), Glasgow Outcome Score (GOS), Mortality. |
1. ICP decreased markedly in all patients during cooling. 2. Actual mortality rates were significantly lower in the TG compared with the CG (62% versus. 72%, p<0.05). 3. The number of patients with good neurological outcome on the GOS was higher in the TG than CG (15.7% versus. 9.7%, p<0.02). |
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Chen et al. (2001) China PCT N=30 |
Population: ABI. Intervention: Participants received hypothermia (33-35°C, treatment) for 10 hr/day over 3-10 days or conventional treatment (control). Outcome Measure: Mortality. |
1. Mortality was significantly lower in the treatment than control group. |
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Tateishi et al. (1998) Japan Case Series N=9 |
Population: ABI; Mean Age=36.9yr; Gender: Male=5, Female=4; Time Post Injury<24hr; Mean GCS=7. Intervention: Participants received mild hypothermia (33-35°C) for a maximum of 6 days induced by repeated intragastric cooling using a nasoduodenal tube of iced half-saline infused during 15-30 min supplemented with surface cooling. Outcome Measures: Intracranial Pressure (ICP), Glasgow Outcome Scale (GOS). |
1. There was a significant reduction in ICP 3 hr after cooling (p<0.05); 4 patients experienced systemic infection complications. 2. Seven patients showed good outcome on GOS 6-12 mo after discharge. |
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Metz et al. (1996) Germany Pre-Post N=10 |
Population: TBI; Mean Age=31 yr; Gender: Male=7, Female=3; Mean Time Post Injury=16 hr; Mean GCS=3.5. Intervention: Participants received hypothermia (32.5°C) via cooling blankets for 24 hr. Outcome Measures: Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP). |
1. Mean ICP significantly decreased from 24 mmHg at baseline to 14 mmHg after treatment (p<0.05). 2. There was no significant change in CPP after treatment. |