Effect of antisecretory factor, given as a food supplement to adult patients with severe traumatic brain injury (SASAT): protocol for an exploratory randomized double blind placebo-controlled trial.

BACKGROUND: Traumatic brain injury (TBI) constitutes a global epidemic. Overall outcome is poor, with mortality ranging from 10 to 70% and significant long-term morbidity. Several experimental reports have claimed effect on traumatic edema, but no clinical trials have shown effect on edema or outcome. Antisecretory factor, an endogenous protein, is commercially available as Salovum®, which is classified as a medical food by the European Union and has shown effect in experimental trauma models and feasibility with signs of effect in 2 pilot case series. The aim of this study is to assess the effect of antisecretory factor in adult patients with severe traumatic brain injury as measured by 30-day mortality, treatment intensity level (TIL), and intracranial pressure (ICP). METHODS/DESIGN: This is a single-center, double-blind, randomized, placebo-controlled clinical phase 2 trial, investigating the clinical superiority of Salovum® given as a food supplement to adults with severe TBI (GCS < 9), presenting to the trauma unit at Tygerberg University Hospital, Cape Town, South Africa, that are planned for invasive ICP monitoring and neurointensive care, will be screened for eligibility, and assigned to either treatment group (n = 50) or placebo group (n = 50). In both groups, the primary outcome will be 30-day mortality, recorded via hospital charts, follow-up phone calls, and the population registry. Secondary outcomes will be treatment intensity level (TIL), scored from hospital charts, and ICP registered from hospital data monitoring. TRIAL REGISTRATION: ClinicalTrials.gov NCT03339505 . Registered on September 17, 2017. Protocol version 3.0 from November 13, 2020.

The role of tertiary neurosurgical intervention in non-missile penetrating injuries of the spine.

PURPOSE: The objective of the study was to determine whether all patients with spinal non-missile penetrating injuries (NMPIs) need to be managed at a tertiary neurosurgical centre. METHODS: A retrospective analysis of clinical, demographic, and imaging records was performed on all NMPI patients referred to the Department of Neurosurgery at Tygerberg Academic Hospital in Cape Town, South Africa, between 1 January 2016 and 31 December 2019. RESULTS: Ninety-six patients were identified (94 males and 2 females) with 35 cervical, 60 thoracic, and 1 lumbar spinal stab. Eighty-six had an incomplete spinal cord injury. Six patients presented with cerebrospinal fluid (CSF) leak, all of which resolved spontaneously. MRI was performed in nine patients. Six patients had retained blades, of which 5 were removed in the emergency room (ER). Surgery was performed in two patients (cervical intramedullary abscess and a retained blade). Two patients developed meningitis, and one an intramedullary abscess. Twenty-two patients had associated injuries (pneumothorax, bowel injury). The average length of stay was 17 days, with 81% being unchanged neurologically. The average time from discharge to leaving the hospital was 11 days. CONCLUSION: Early management of NMPI should include prophylactic antibiotics and wound debridement and X-ray imaging to exclude retained blades. Bowel and lung injury must be managed accordingly. Tertiary neurosurgical referral is not routinely necessary and is only warranted for deteriorating neurology, retained blades not removable in the ER, and respiratory failure secondary to spinal cord injury. Complications include meningitis and persistent CSF leak, which should be referred timeously.

Complications, outcomes, and management strategies of non-missile penetrating head injuries.

OBJECTIVE: While high-velocity missile injury (gunshot) is associated with kinetic and thermal injuries, non-missile penetrating head injury (NMPHI) results in primary damage along the tract of the piercing object that can be associated with significant secondary complications. Despite the unique physical properties of NMPHI, factors associated with complications, expected outcomes, and optimal management have not been defined. In this study, the authors attempted to define those factors. METHODS: Consecutive adult patients with NMPHI who presented to Tygerberg Academic Hospital (Cape Town, South Africa) in the period from August 1, 2011, through July 31, 2018, were enrolled in a prospective study using a defined treatment algorithm. Clinical, imaging, and laboratory data were analyzed. RESULTS: One hundred ninety-two patients (185 males [96%], 7 females [4%]) with 192 NMPHIs were included in this analysis. The mean age at injury was 26.2 ± 1.1 years (range 18-58 years). Thirty-four patients (18%) presented with the weapon in situ. Seventy-one patients (37%) presented with a Glasgow Coma Scale (GCS) score of 15. Weapons included a knife (156 patients [81%]), screwdriver (18 [9%]), nail gun (1 [0.5%]), garden fork (1 [0.5%]), barbeque fork (1 [0.5%]), and unknown (15 [8%]). The most common wound locations were temporal (74 [39%]), frontal (65 [34%]), and parietal (30 [16%]). The most common secondary complications were vascular injury (37 patients [19%]) and infection (27 patients [14%]). Vascular injury was significantly associated with imaging evidence of deep subarachnoid hemorrhage and an injury tract crossing vascular territory (p ≤ 0.05). Infection was associated with delayed referral (> 24 hours), lack of prophylactic antibiotic administration, and weapon in situ (p ≤ 0.05). A poorer outcome was associated with a stab depth > 50 mm, a weapon removed by the assailant, vascular injury, and eloquent brain involvement (p ≤ 0.05). Nineteen patients (10%) died from their injuries. The Glasgow Outcome Scale (GOS) score was linearly related to the admission GCS score (p < 0.001). One hundred forty patients (73%) had a GOS score of 4 or better at discharge. CONCLUSIONS: The most common NMPHI secondary complications are vascular injury and infection, which are associated with specific NMPHI imaging and clinical features. Identifying these features and using a systematic management paradigm can effectively treat the primary injury, as well as diagnose and manage NMPHI-related complications, leading to a good outcome in the majority of patients.