Table 1. Characteristics of patients with TBI.
| Study ID | Design | Number of patients(ICP+/ICP -) | Patientsage(years,range or mean±SD) | Male | Diffuse injury II-IV and evacuated mass lesion(ICP+/ICP -) | Midline shift ≥5 mm(ICP+/ICP -) | ICU and hospital stay(ICP+/ICP -)(mean, days) | Neurosurgical Treatment(ICP+/ICP -) | Paitents selection criteria | Criteria for ICP+ | Definitons of outcomes | Therapeutic strategies | Studies quality assessed by NOS † |
| Chesnut 2012 | multicenter RCT | 157/167 | >13(22–44) | 87%(283/324) | 97% (152/157)/95% (159/167) | 34%(53/157)/39%(64/164) | (12 and 26)/(9 and ?) | 68%(107/157)/74%(123/166) | Inclusion: Patients with 3< GCS <8(with a score on the GCS motor component of 1 to 5 if the patient was intubated) or a higher score on admission that dropped to the specified range within 48 hours after injury. Exclusion: Patients with a GCS of 3 and bilateral fixed and dilated pupils and those with an injury believed to be unsurvivable | randomized allocation | GOSE ranges from 1 to 8, with 1 indicating death and 8 indicating the most favorable recovery. Patients with scores ranging from 2 to 4 were classified as having an unfavorable outcome, andthose with scores ranging from 5 to 8 were classified as having a favorable outcome at 6 months | Standard supportive care for each patient, including mechanical ventilation, sedation, and analgesia. Non-neurologic problems were managed aggressively in both groups.Individual treatments: mannitol, hypertonic saline, furosemide,hyperventilation, CSF drainage, barbiturates Neurosurgical procedures: craniotomy for mass lesion, craniectomy, craniectomy with other neurosurgical procedureICP-: more hypertonic saline and hyperventilationICP treatment thresholds: 20 mmHg | NA |
| Biersteker 2012 | prospective observational multicenter cohort study | 123/142 | ≥16(26–69) | 68%(180/265) | 85% (105/123)/70%(99/142) | 34%(42/123)/24%(34/142) | (10.8 and 22)/(2.7 and 7.5) | 69%(85/123)/39%(56/142) | Inclusion: GCS ≤13(GCS ≤13 before intubation if the patient was intubated).Exclusion: Patients’age <16 years, and hospital admission >72 hours zafter the injury was sustained or gunshot injury | 1) patients with severe TBI (GCS ≤8 on ED admission) and an abnormal CT scan; 2) patients with severe TBI without CT abnormalities but with at least two of the following criteria: age >40 yrs, unilateral or bilateral motor posturing (ED GCS motor score ≤3), or systolic blood pressure <90 mm Hg before hospital arrival or at the ED. | GOSE ranges from 1 to 8, with 1 indicating death and 8 indicating the most favorable recovery. Patients with scores ranging from 2 to 4 were classified as having an unfavorable outcome at 6 months | Standard supportive care for each patient, including mechanical ventilation, sedation, intra- and extracranial surgery.Brain-specific treatment included osmotherapy (mannitol or hypertonic saline), vasopressor medication to maintain cerebral perfusion pressure, hyperventilation (Paco 2≤4 kPa), CSF drainage, hypothermia (body temperature <35°C), and use of barbiturates. ICP+: more osmotherapy, vasopressors, hypothermia, CSF drainage, hyperventilation, and acute craniotomyICP treatment thresholds: 20 mmHg | 8 |
| Kostic2011 | RCT | 32/29 | 42.2±22 | 87%(53/61) | NA | NA | NA | Total36% (22/61) | Inclusion: patients with brain trauma and with: GCS≤8 or abnormal CT scan of the brain in terms of present mass lesions. | randomized allocation | GCS at 21st days | Appropriate nutritional support, glycemia control,and peptic ulcer prophylaxis was provided to all ofthe patients. General treatment: 1. headboard at 30°,2. avoidance of the neck flexion, 3. avoidance of hypotension (SAP<90 mm Hg), 4. controlling hypertension (nitroprusside, beta blockers), ventilation to normocarbia (pCO2 = 35–40 mmHg), light sedation (e.g.codeine).Specific treatment: 1. deep sedation and/or relaxation (fentanyl, vecuronium), 2.drainage of 3 to 5 ml of CSF (in cases of intraventricularly placed systems), 3. mannitol bolus at first and then application intravenously for 6 hours, 4. hyperventilation to pCO2 = 30–35 mmHg. Ultimate treatments: 1. high doses of barbiturates (barbituric coma), 2. hyperventilation to pCO2 = 25–30 mmHg, 3. internal or external decompression.ICP treatment thresholds: 20 mmHg | NA |
| Griesdale 2010 | observationalcohort study | 98/73 | NA | 77%(132/171) | NA | NA | (14 and ?)/(6 and ?) | NA | Inclusion: GCS ≤8.Exclusion: non-severe TBI, patients who died within 12 hours of ICU admission, and patients with concomitant high cervical spine injury or obvious non-traumatic causes of their decreased level of consciousness | NA | GCS at hospital discharge and 28 th days | All patients are maintained with: 1.head of bed elevated above 30° with their neck in a neutral position. 2. mean arterial pressure≥70 mmHg and PaO2≥70 mmHg. 3. If ICP increases >20 mmHg for greater than five minutes without stimulation, the EVD is opened to 26 cm H2O and CSF is drained. 4. Cerebral oxygen extraction ratio is maintained <40% by ensuring adequate cerebral perfusion pressure, sedation and paralysisand careful titration of arterial CO2 tension to modify cerebral blood flow. 5. hyperthermia is avoided by using acetaminophen 650 mg every four hours and cooling blankets if required to keep the core temperature <38°. ICP+: more mannitol use and craniotomy.ICP treatment thresholds: 20 mmHg | 7 |
| Shafi2008 | observationalmulticentercohort study | 708/938 | 33±8.4 | 76%(1248/1646) | NA | NA | (? and 22)/(? and 25) | 59%(419/708)/39%(248/938) | Inclusion: AIS head scores 3–6, GCS≤8, blunt mechanism, age 20 to 50 years, admission to an ICU for at least 3 days.Exclusion: Early deaths (<48 hours) and delayed admissions (>24 hours after injury) | GCS≤8 in the ED, and CT scan demonstrating a TBI | modified FIM scores range from 1 (completely dependent) to 4 (completely independent) for each of the three functions assessed for a total ranging from 3 to 12 at discharge | NA | 8 |
| Mauritz 2008 | multicentercohort study | 1031/825 | 29–74 | 73%(1363/1856) | NA | NA | (18 and ?)/(9 and ?) | NA | Inclusion: AIS head >2,GCS<9, TBIExclusion: discharged aliveafter <4 days of intensive care, without a documented GCS | NA | AIS and GCS at discharge | Standard supportive care for each patient, including mechanical ventilation, sedation, analgesia, intra- and extracranial surgery. Brain-specific treatment: barbiturates, steroids, mannitol, hypertonic saline, hyperventilation, hypothermia, catecholamines,and fluid balanceICP-: more mechanical ventilation,catecholamines use at first week.ICP treatment thresholds: 20 mm Hg | 8 |
| Mauritz 2007 * | multicentercohort study | 248/152 | 50±21 | 72%(286/400) | NA | 28%(69/247)/30%(45/152) | NA | 91%(224/247)/38%(57/152) | Inclusion: patients fulfilled the criteria for severe TBI, GCS,AIS head, ISSExclusion: died at the scene, during transport to the hospital, or immediately after admission to the emergency room | NA | GOS at 6 months. vegetative state and severe disability as unfavourable outcome; good recovery, moderate disability as favourable outcome | Standard supportive care for each patient, including mechanical ventilation, sedation, analgesia, intra- and extracranial surgery. Brain-specific treatment: barbiturates, steroids, mannitol, hypertonic saline, hyperventilation, hypothermia, catecholamines, and fluid balance.ICP+: more craniectomy and craniotomy.ICP treatment thresholds: 20 mm Hg | 8 |
| Stocchetti 2001 | observational multicentercohort study | 344/589 | >1642±21 | 74%(738/1000) | Total 86% (862/1000) | NA | NA | NA | Inclusion: all adults(>16 yrs) with GCS≤12 admitted to their care within 24 hours of injury. | NA | GOS at 6 months. death; vegetative state, severe disability as unfavourable outcome; moderate disability, good recovery as favourable outcome. | NA | 7 |
| Lane2000 | observationalmulticentercohort study | 541/4946 | 40±24 | 72%(8681/12058) | NA | NA | (9.7 and 44)/(4.3 and 22.8) | NA | Inclusion: TBI and a maximum AIS score in the head region (MAIS head) >3, ISS | NA | FIM at discharge | NA | 7 |
TBI: trauma brain injury; ED:emergence department; RCTs: randomized controlled trials; ICP+: intracranial pressure monitoring; ICP-: no intracranial pressure monitoring; AIS: abbreviated injury score; GCS: glasgow coma scale; GOSE: the extended glasgow outcome scale; FIM: functional independence measure; GOS: glasgow outcome scale; ISS: injury severity score; AIS: abbreviated injury scale; CSF: cerebrospinal fluid; EVD: external ventricular drain; NOS: newcastle - ottawa quality assessment scale; NA: not available.
* Data from correspondence author.
†
A paper with NOS score ≥7 points was regarded as the paper with high-quality study.