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Long-Term Outcome in Traumatic Brain Injury Patients with Midline Shift: a Secondary Analysis of the Phase 3 COBRIT Clinical Trial

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Long-Term Outcome in Traumatic Brain Injury Patients with Midline Shift: a Secondary Analysis of the Phase 3 COBRIT Clinical Trial CLINICAL ARTICLE J Neurosurg 131:596–603, 2019 Long-term outcome in traumatic brain injury patients with midline shift: a secondary analysis of the Phase 3 COBRIT clinical trial Ross C. Puffer, MD,1 John K. Yue, BS,2 Matthew Mesley, MD,2 Julia B. Billigen, RN,2 Jane Sharpless, MS,2 Anita L. Fetzick, RN, MSN,2 Ava Puccio, PhD,2 Ramon Diaz-Arrastia, MD, PhD,3 and David O. Okonkwo, MD, PhD2 1Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota; 2Department of Neurosurgery, UPMC, Pittsburgh; and 3Department of Neurosurgery, University of Pennsylvania, Philadelphia, Pennsylvania OBJECTIVE Following traumatic brain injury (TBI), midline shift of the brain at the level of the septum pellucidum is often caused by unilateral space-occupying lesions and is associated with increased intracranial pressure and worsened morbidity and mortality. While outcome has been studied in this population, the recovery trajectory has not been re- ported in a large cohort of patients with TBI. The authors sought to utilize the Citicoline Brain Injury Treatment (COBRIT) trial to analyze patient recovery over time depending on degree of midline shift at presentation. METHODS Patient data from the COBRIT trial were stratified into 4 groups of midline shift, and outcome measures were analyzed at 30, 90, and 180 days postinjury. A recovery trajectory analysis was performed identifying patients with outcome measures at all 3 time points to analyze the degree of recovery based on midline shift at presentation. RESULTS There were 892, 1169, and 895 patients with adequate outcome data at 30, 90, and 180 days, respectively. Rates of favorable outcome (Glasgow Outcome Scale–Extended [GOS-E] scores 4–8) at 6 months postinjury were 87% for patients with no midline shift, 79% for patients with 1–5 mm of shift, 64% for patients with 6–10 mm of shift, and 47% for patients with > 10 mm of shift. The mean improvement from unfavorable outcome (GOS-E scores 2 and 3) to favor- able outcome (GOS-E scores 4–8) from 1 month to 6 months in all groups was 20% (range 4%–29%). The mean GOS-E score for patients in the 6- to 10-mm group crossed from unfavorable outcome (GOS-E scores 2 and 3) into favorable outcome (GOS-E scores 4–8) at 90 days, and the mean GOS-E of patients in the > 10-mm group nearly reached the threshold of favorable outcome by 180 days postinjury. CONCLUSIONS In this secondary analysis of the Phase 3 COBRIT trial, TBI patients with less than 10 mm of midline shift on admission head CT had significantly improved functional outcomes through 180 days after injury compared with those with greater than 10 mm of midline shift. Of note, nearly 50% of patients with > 10 mm of midline shift achieved a favorable outcome (GOS-E score 4–8) by 6 months postinjury. https://thejns.org/doi/abs/10.3171/2018.2.JNS173138 KEYWORDS TBI; midline shift; outcome; clinical trial; trauma; traumatic brain injury OLLOWING traumatic brain injury (TBI), midline shift line shift can be the result of heterogeneous morphologies of the brain at the level of the septum pellucidum consisting of hemorrhage, infarction, cerebral edema, and is often caused by unilateral, space-occupying le- hydrocephalus, or a combination of these factors. Current Fsions and is associated with increased intracranial pressure TBI guidelines suggest that mass lesions causing > 5 mm and worsened morbidity and mortality.1,2,4,6,13,16,20,21,27,33 The of midline shift associated with abnormal neurological ex- degree of shift is associated with abnormal neurological amination results that are potentially reversible should be examination results due to progressive dysfunction of the considered for surgical evacuation.3,11,12,17,18,22,23,29,31,32,36 diencephalon subsequent to mass effect.5,9,27 In TBI, mid- Patients with TBI who present with substantial midline ABBREVIATIONS COBRIT = Citicoline Brain Injury Treatment; CONSORT = Consolidated Standards of Reporting Trials; FITBIR = Federal Interagency Traumatic Brain Injury Research; GCS = Glasgow Coma Scale; GOS-E = Glasgow Outcome Scale–Extended; TBI = traumatic brain injury. SUBMITTED December 14, 2017. ACCEPTED February 16, 2018. INCLUDE WHEN CITING Published online August 3, 2018; DOI: 10.3171/2018.2.JNS173138. 596 J Neurosurg Volume 131 • August 2019 ©AANS 2019, except where prohibited by US copyright law Unauthenticated | Downloaded 10/02/21 01:47 PM UTC Puffer et al. FIG. 1. CONSORT diagram. shift and abnormal neurological examination results may (FITBIR) informatics system. All patient information have a poorer prognosis with significant implications for within the FITBIR system for this trial is de-identified, family discussions and surgical decision-making. Many of and therefore institutional review board approval was not these decisions are made based on incomplete information required. Our institutional business officer (per FITBIR and speculation, and withdrawal of care is a leading cause requirements) evaluated the method of data acquisition of in-hospital death in patients with severe TBI.19,25,28 How- and usage to ensure that data access protocols and data ever, there is a paucity of long-term outcome data regard- management were performed in accordance with regula- ing improved rates of recovery after TBI.20,27 tions. The Citicoline Brain Injury Treatment (COBRIT) tri- The full details of the COBRIT trial, a multicenter, al34,35 was a Phase 3, double-blind, randomized controlled double-blind randomized controlled trial performed at 8 trial within the clinical trials network that was designed Level I trauma centers within the US, have previously been to evaluate the efficacy of citicoline to improve functional published.34,35 Inclusion criteria were age 18–70 years, non- and cognitive outcomes after TBI; the trial included pa- penetrating TBI classified as complicated mild (CT posi- tients with complicated mild (positive acute intracranial tive, GCS scores 13–15), moderate (GCS scores 9–12), and pathology on the initial head CT scan but Glasgow Coma severe (GCS scores 3–8). Additional CT inclusion criteria Scale [GCS] scores 13–15), moderate (GCS scores 9–12), were the presence of intraparenchymal hemorrhage > 10 and severe (GCS scores 3–8) TBI. The trial was stopped mm in any diameter, midline shift > 5 mm, acute extra- for futility, as it failed to demonstrate improved functional axial hematoma > 5 mm, intraventricular hemorrhage on or cognitive outcomes with citicoline treatment; however, at least 2 contiguous 5-mm slices, and subarachnoid hem- the large number of enrolled patients and detailed func- orrhage on at least 2 contiguous 5-mm slices. Patients were tional and cognitive outcome measures studied at 30, 90, not required to have > 5 mm of midline shift to be included and 180 days made this enriched data set a valuable source in the COBRIT trial, but this finding on CT scanning was considered positive if it was the only finding present at for subset analyses. We utilized the prospective COBRIT 34,35 trial data to analyze the degree of midline shift on ad- baseline. Patients were excluded if they had bilateral mission CT scanning and its association with functional fixed and dilated pupils, imminent death, or history of outcomes at 30, 90, and 180 days after TBI. serious psychiatric or neurological illness that would af- fect neuropsychological outcomes.34,35 The Consolidated Standards of Reporting Trials (CONSORT) diagram for Methods COBRIT is included in Fig. 1. Access to the COBRIT trial database was granted by Demographic, radiological, and outcome measures for the Federal Interagency Traumatic Brain Injury Research each TBI patient were downloaded from the FITBIR sys- J Neurosurg Volume 131 • August 2019 597 Unauthenticated | Downloaded 10/02/21 01:47 PM UTC Puffer et al. TABLE 1. Selected demographics mean age of this cohort was 40.4 ± 0.5 years, and 651 No. of Patients (73%) patients were male. The GOS-E was calculated at Variable (%) a mean of 31.5 ± 0.2 days from injury. The cohort was separated into 4 categories of midline shift: no midline Total 1213 shift (n = 697), 1–5 mm of midline shift (n = 133, mean Age, yrs 2.8 ± 0.1 mm), 6–10 mm of midline shift (n = 49, mean 7.5 18–30 434 (36) ± 0.04 mm), and > 10 mm of midline shift (n = 18, mean 31–45 266 (22) 15.1 ± 0.15 mm). 46–60 344 (28) GOS-E scores at 30 days are presented in Fig. 2 and >60 171 (14) Table 2. The differences among midline shift groups were statistically significant by chi-square analysis (p < 0.0001). Sex In patients with no midline shift on the admission CT scan Female 310 (26) (n = 692), 31 (4.5%) patients died, 215 (31% had an unfa- Male 903 (74) vorable outcome, and 446 (64.5%) patients had a favorable Mechanism of injury outcome. In patients with 1–5 mm of midline shift at base- Motor vehicle collision 594 (49) line CT (n = 133), 8 (6%) died, 54 (41%) had an unfavor- Struck by vehicle 72 (6) able outcome, and 71 (53%) had a favorable outcome. In patients with 6–10 mm of midline shift (n = 49), 4 (8%) Fall 378 (31) died, 28 (57%) had an unfavorable outcome, and only 17 Sports 7 (0.5) (35%) had a favorable outcome. In patients with > 10 mm Assault 113 (9) of midline shift (n = 18), the mortality rose to 28% (n = 5), Other mechanism 49 (4.5) the unfavorable outcome rate rose to 44% (n = 8), and the Admission GCS score favorable outcome rate at 30 days was 28% (n = 5). 13–15 w/ imaging abnormality (complicated mild) 659 (54) 9–12 (moderate) 165 (14) 90-Day Outcomes 3–8 (severe) 389 (32) There were 1169 patients with adequate follow-up in- formation to be included in the assessment of outcomes by the GOS-E (unfavorable: scores 2 and 3; favorable: scores 4–8) at 90 days postinjury.
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