The effect of combination therapy with erythropoietin and methylprednisolone in patients with traumatic cervical spinal cord injury: a pilot randomized controlled trial.

STUDY DESIGN: Pilot double-blinded randomized controlled trial. OBJECTIVES: To investigate the additive effect of recombinant human erythropoietin (rhEPO) on functional outcome and disability in patients with traumatic cervical spinal cord injury (TCSCI). SETTINGS: University-affiliated hospital in Mashhad, Iran. METHODS: Patients with acute TCSCI admitted within 8 h after injury were randomly assigned to receive only methylprednisolone (M group) or rhEPO 500 IU/mL plus methylprednisolone (M + E group). All the patients underwent surgery within the next several days. Neurological function was assessed on admission, and at 6th and 12th months after the injury according to the sphincter function and American spinal cord injury association (ASIA) scale. RESULTS: Overall, 54 patients (mean age: 39.7 ± 13.3 years) including 46 (85%) males were studied in two groups of 27. The likelihood of developing adverse neurological outcomes (ASIA impairment score of A compared to D or E) was not significantly different between the groups after 6 (OR = 0.39, 95% CI = 0.03-4.80, P = 0.46) and 12 months (OR = 0.83, 95% CI = 0.11-6.11, P = 0.86). The groups also showed no significant difference in 1-year mortality (OR = 0.83, 95% CI = 0.25-2.74, P = 0.76). CONCLUSIONS: It is not clear whether combination therapy with erythropoietin compared to methylprednisolone alone improves neurological functions of patients with TCSCI. Our study provides interim data to guide future larger definitive trials.

Determinants of accuracy of freehand external ventricular drain placement by neurosurgical trainees.

BACKGROUND: The external ventricular drain (EVD) placement is one of the most common neurosurgical procedures. This operation is performed by freehand technique in the majority of cases; therefore, the operator's experience plays an important role in success and possible morbidity of this procedure. OBJECTIVE: To evaluate the accuracy and safety of EVD placement by junior neurosurgery residents and factors predicting accuracy of EVD placement. METHODS: This is a prospective cohort study conducted at our academic medical center, between September 2017 and August 2018. All patients 18 years or older who required EVD placement were included. The accuracy and complications of EVD placement were assessed in the first and second year resident cohorts as well as by their level of experience, using descriptive statistics. Univariate and multivariate models were used to assess predictive factors for optimal EVD. RESULTS: A total of 100 EVDs were placed in 100 patients during the study period. According to Kakarla classification, the catheter was optimally placed in 80% of cases. The first year residents had a significantly higher rate of suboptimal burr hole placement compared to the second year residents (66.7% versus 27.1%, p = 0.004). The trainees with less than 10 EVD placement experience also had a significantly higher rate of suboptimal burr hole placement (55.2% vs. 23.9%, p = 0.003), significantly longer duration of operation (43.1 min ± 14.9SD vs 34.2 min ± 9.6 p = 0.005), and significantly lower rate of optimal EVD location (85.9% versus 65.5%, p = 0.023). Optimal location of the burr hole was the only significant predictor of optimal EVD placement in multivariate analysis (OR 11.9, 95% CI 3.2-44.6, p < 0.001). CONCLUSIONS: Neurosurgery residents experience and optimal burr hole placement are the main predicators of accurate EVD placement.

Diffuse subarachnoid and intraventricular hemorrhage as the presenting sign of a conus medullaris arteriovenous malformation: Case report.

Spinal arteriovenous malformations (AVMs) are rare vascular lesions that usually present with progressive myelopathy or less frequently, with acute neurological deficit due to hematomyelia or spinal subarachnoid hemorrhage (SAH). There are few reports of concomitant cerebral SAH and intraventricular hemorrhage (IVH) following rupture of a spinal AVM. Herein, we present a rare case of conus medullaris arteriovenous malformation, out-breaking with loss of consciousness due to SAH and IVH.

Comparison of open surgical discectomy versus plasma-laser nucleoplasty in patients with single lumbar disc herniation.

BACKGROUND: Intervertebral disc herniation is a major cause of low back pain. Several treatment methods are available for lumbar disc herniation including Chemonucleolysis, open surgery, nucleoplasty, laser disc decompression, and intradiscal electrothermal therapy. The high prevalence of lumbar disc herniation necessitates a minimally invasive yet effective treatment method. In this study, we compared the outcomes of open surgery and nucleoplasty method in patients with single lumbar disc herniation. MATERIALS AND METHODS: This study was a noninferiority randomized clinical trial conducted in one of the University Hospitals of Isfahan Medical University; The Alzahra Hospital. About 200 patients with the diagnosis of lumbar disc herniation were recruited and were assigned to either the treatment or control groups using block randomization. One group received open surgery and the other group received nucleoplasty as the method of treatment. Patients were revisited at 14 days, 1, 2, 3 months, and 1-year after surgery and were assessed for the following variables: Lower back pain, lower limb pain, common complications of surgery (e.g., discitis, infection and hematoma) and recurrence of herniation. RESULTS: The mean (standard deviation) severity of low back pain was reduced from 6.92 (2.5) to 3.43 (2.3) in the nucleoplasty group (P = 0.04) and from 7.5 (2.2) to 3.04 (1.61) in the discectomy group (P = 0.73). Between group difference was not statistically significant (P = 0.44), however, time and treatment interaction was significant (P = 0.001). The level of radicular pain evaluated 1 year after treatment was reduced from 8.1 (1.2) to 2.9 (1.2) (P = 0.004) and from 7.89 (2.1) to 3.6 (2.5) (P =0.04) in the discectomy and the nucleoplasty groups respectively, significant interaction between time and treatment options was observed (P < 0.001) while there was no significant difference between two treatment groups (P = 0.82). CONCLUSION: Our results show that while nucleoplasty is as effective as open discectomy in the treatment of lumbar disc herniation, it is also less invasive with higher patient compliance. Taking factor such as decreased cost and duration of the surgery, as well as faster recovery in patients into account; we suggest considering nucleoplasty as an effective method of treatment in patients with single-level disc herniation.

Recent Advances in the Treatment of Spinal Cord Injury.

Spinal cord injury (SCI) is a complex, multifaceted, progressive, and yet incurable complication that can cause irreversible damage to the individual, family, and society. In recent years strategies for the management and rehabilitation of SCI besides axonal regeneration, remyelination, and neuronal plasticity of the injured spinal cord have significantly improved. Although most of the current research and therapeutic advances have been made in animal models, so far, no specific and complete treatment has been reported for SCI in humans. The failure to treat this complication has been due to the inherent neurological complexity and the structural, cellular, molecular, and biochemical characteristics of spinal cord injury. In this review, in addition to elucidating the causes of spinal cord injury from a molecular and pathophysiological perspective, the complexity and drawbacks of neural regeneration that lead to the failure in SCI treatment are described. Also, recent advances and cutting-edge strategies in most areas of SCI treatment are presented.

Diagnostic Value of Computed Tomography Angiography in Confirmation of Brain Death.

BACKGROUND: Accurate and on-time confirmation of brain death (BD) is necessary to prevent unnecessary treatment and allow for well-timed organ harvest for transplantation. Although the clinical criteria for BD are legally reliable in some countries, others might prefer complementary ancillary tests to assess the brain's electrical activity and/or blood circulation. The present study aims to define the sensitivity and specificity of computed tomography angiography using 4-, 7-, and 10-point tests compared with the clinical criteria and electroencephalographic findings in patients with BD. METHODS: A total of 32 patients with a confirmed diagnosis of BD according to their clinical criteria (cases) and 18 patients with a Glasgow coma scale score of 3 and absent brain stem and papillary reflexes who had spontaneous respiration (controls) were included in the present study. All the patients had blood pressure >90 mm Hg, diuresis >100 mL/hour, and central venous pressure >6-8 mm Hg, and undergone computed tomography angiography (CTA). The 4-, 6-, and 10-point criteria were used to determine the opacity and lack of opacity of the brain vessels in the CTA evaluation scales for the diagnosis of BD. RESULTS: The 2 groups were homogeneous in terms of age, gender distribution, and coma etiology. All 18 patients in the control group received a score of 0 in the 4-, 7-, and 10-point scores. In contrast, the average values for the 4-, 7-, and 10-point scores for the patients with confirmed BD were 3.75 ± 0.67, 6.4 ± 1.36, and 9.06 ± 2.2, respectively. Of the patients with BD, 28 (87.5%), 26 (81.25%), and 25 (78.12%) received the full score for the 4-point, 7-point, and 10-point tests. The sensitivity, specificity, and negative and positive predictive values for all 3 scores were 100%. Also, the sensitivity for the various cerebral vessels were as follows: internal cerebral vein, 100%; great cerebral vein, 96.9%; posterior 2, 90.6%, middle 4, 87.5%; basilar artery, 84.4%; and anterior 3, 84.4%. Finally, the specificity for the lack of opacification in all these vessels for the diagnosis of BD was 100%. CONCLUSIONS: According to our findings, the CTA-based 4-point scoring system with 100% specificity can be used with the clinical examination findings to confirm BD.

Intraocular lymphoma masquerading as unilateral hypopyon anterior uveitis: a case report.

PURPOSE: To report an unusual case of unilateral anterior segment large B-cell intraocular lymphoma (IOL) presenting as a recurrent hypopyon anterior uveitis. CASE PRESENTATION: A 55-year-old female was referred because of recurrent unilateral anterior hypopyon uveitis with partial response to topical corticosteroid. All of the laboratory tests, review of systems and ocular sampling results were unremarkable. Given a high concern for masquerades syndromes, cytological specimens were obtained 3 times and the last sample showed large B cell lymphoma. First, it appeared confined to the eye and initially responded favorably to local chemotherapy (methotrexate and rituximab) but later went on to develop systemic involvement. CNS lymphoma was detected on the third brain MRI 6 months following ocular involvement. At this time, systemic chemotherapy was started. In the last 18 months' follow-up, visual acuity was 20/30 in the right eye without posterior segment or fellow eye involvement. CONCLUSION: Unusual presentation of intraocular lymphoma as a unilateral isolated anterior hypopyon uveitis should be kept in mind. This report emphasizes the importance of precise work-ups and multiple ocular biopsies to confirm the diagnosis of intraocular lymphoma.

Targeted Drug Delivery in Brain Tumors-nanochemistry Applications and Advances.

BACKGROUND: Despite advances in surgery, radiotherapy and chemotherapy, brain tumors are still a major health issue due to poor prognosis and high mortality rate. The current treatment options have limited efficiency. The main barriers to effective clinical treatment are systemic toxicity of cytotoxic compounds, the physical and functional barrier of the blood-brain barrier (BBB), and low selectivity of the therapeutic agents to tumor cells. OBJECTIVE: The study aimed to review the advances in targeted drug delivery systems and strategies for brain tumors. METHODS: We searched the electronic databases of PubMed, EMBASE, Web of Science, BIOSIS Previews, Cambridge Scientific Abstracts, google scholar and additional sources for published and unpublished trials using the set search terms. The date of the most recent search was 20 March 2020. The studies investigating the applications of targeted drug delivery for brain tumors were collected and the most relevant studies were selected for a comprehensive review. RESULTS: Different anticancer agents and nucleic acid-based therapies have been developed and assessed as novel targeted drug delivery techniques for brain tumors. New vehicles include polymeric and liposomal nanoparticles (NPs), wafers, microchips, microparticle-based nanosystems and cells-based vectors. Strong evidence from preclinical and translational studies indicate the great potential of these NPs-based technologies for use in brain tumors and improving the therapeutic outcomes. Research is ongoing to develop effective new anticancer agents as well as strategies for BBB modulation and penetration. CONCLUSION: New targeted drug delivery systems based on stimuli-responsive NPs have shown promising outcomes in brain tumors. Advances in material design and nanochemistry lead to enhanced intracranial concentrations. Non-invasive technologies such as magnetic resonance imaging- guided ultrasound and high-intensity focused ultrasound have been utilized for BBB modulation with higher precision and improved drug delivery performance.

Nonsyndromic Primary Diffuse Leptomeningeal Melanomatosis in a Child.

INTRODUCTION: In this study, we present a case of primary diffuse leptomeningeal melanomatosis (PDLM), without neurocutaneous melanosis syndrome. A female patient (age: 14 years) presented with headache, nausea, vomiting, vertigo, diplopia, and lower limb weakness. The magnetic resonance imaging (MRI) showed leptomeningeal isointensity on T1- and T2-weighted images and hyperintensity on fluid attenuation inversion recovery (FLAIR) sequences. Definitive histological examination showed a densely cellular tumor, characterized by irregular clusters of large pleomorphic cells and melanin in tumor cells. Adjuvant therapy was refused by the parents, and the patient died within six months. Primary diffuse leptomeningeal melanomatosis is recognized as an uncommon and malignant melanoma affecting the central nervous system. In case comorbidities are not diagnosed in patients with unusual symptoms of meningitis, diagnostic methods such as cerebrospinal fluid analysis and central nervous system biopsy can be helpful in identifying other underlying conditions.

Giant Cerebral Hydatid Cyst: A Rare Case Report.

The diagnosis of hydatid cyst should be considered in children with seizure in endemic regions.

Spinopelvic Parameters among Healthy Volunteers in Iran.

BACKGROUND: Recently, in approach to spinal pathologies, the whole spine should be considered as a biomechanical unit. Studies have shown the great importance of sagittal and coronal balance and the relationship between the various parts of spine together and pelvis. Former studies have shown a close relationship between spinopelvic parameters and sagittal balance. A complete understanding of sagittal balance basics is needed to achieve the best outcome and avoiding future complications after treatment of spinal deformities. In this study, the normal range of spinopelvic parameters among healthy volunteers in Iran has been evaluated. METHODS: This cross-sectional study was conducted on healthy volunteers in 2017. The lateral whole-spine X-ray was obtained under the standard conditions. Two spine surgeons measured the parameters including pelvic incidence, pelvic tilt, sacral slope and lumbar lordosis. RESULTS: In this study 100 volunteers were studied; out of whom, 41 participants were male and the mean age was 47.5±11.7 years. The average pelvic incidence, pelvic tilt, and sacral slope were 51.5±10.9, 17.4±9.9, and 34.8±8.8 degrees, respectively. The pelvic tilt was significantly lower in women. It was found that with increasing age, the pelvic incidence and pelvic tilt increases while lumbar lordosis decreases (P<0.05). CONCLUSION: This study is the first study on the normal range of spinopelvic parameters in healthy individuals in Iran.. Our data showed that PT and PI-LL are significantly lower in women, while, PT, PI and PI-LL increase and LL decreases in older ages.

Rate and Risk Factors of Early Ventriculoperitoneal Shunt Revision: A Five-Year Retrospective Analysis of a Referral Center.

BACKGROUND: Cerebral shunts are the mainstay treatment of hydrocephalus. Because most previous studies have focused on factors related to long-term outcomes of shunt surgery, we aimed to assess the rates and causes of 30-day ventriculoperitoneal shunt (VPS) failure in a single referral center over 5 years in both adult and pediatric patients. METHODS: Patients who underwent VPS surgery from February 2012 to February 2017 in Ghaem Teaching Hospital, Mashhad, Iran were evaluated retrospectively through clinical history, operative reports, imaging studies, and follow-up notes. Data of 12 possible factors related to shunt failure were collected comprising age, gender, household income, level of education, cause of hydrocephalus, causes of revision, type of failure, anatomic site, duration of operation, time of surgery, surgeons' level of expertise, and Glasgow Coma Scale (GCS) score. RESULTS: Among 403 VPS placements, 121 VPS revisions were performed, and 82 eligible patients were included in the study (57.3% male and 42.7% female). The 30-day shunt failure rate was 24.4% among all revisions. Obstruction and malposition were the most common causes of early revisions. Six factors were statistically significant in the univariate analysis. After adjustment in a logistic regression model, 2 factors, namely surgeons' level of expertise (odds ratio, 10.33; 95% confidence interval, 1.08-98.80) and anatomic site of the shunt (odds ratio, 10.28; 95% confidence interval, 1.21-87.35) were associated with early shunt revision. CONCLUSIONS: Shunt surgeries performed by junior residents and shunts placed in the frontal site were associated with early shunt failure.

Enoxaparin in the treatment of severe traumatic brain injury: A randomized clinical trial.

BACKGROUND: Enoxaparin was shown to have a neuroprotective effect in animal models as well as a human study following traumatic brain injury. This study was conducted to assess the effect of enoxaparin on the clinical outcome of severe traumatic brain injury (TBI) and its safety. METHODS: This study is a randomized double-blinded placebo-controlled trial. The inclusion criteria were age 16-70, a closed head injury, a postresuscitation Glasgow Coma Scale (GCS) between 5 and 8, and a latency time between the injury and entering the study of less than 5 h. The patients were randomized into enoxaparin and placebo groups. In the enoxaparin group, 0.5 mg/kg enoxaparin was injected subcutaneously every 6 h in six total doses. The two groups were compared for the occurrence of intracranial hematoma (ICH) and for clinical neurological outcome, assessed by the Glasgow Outcome Scale. RESULTS: Twenty-seven patients were assigned to the placebo group and 26 to the enoxaparin group. The two groups were similar regarding baseline characteristics, including age, sex, postresuscitation GCS, and best motor response. The occurrence of new ICH or an ICH size increase was insignificantly more frequent in the enoxaparin group than the placebo group (26.9% vs. 7.4%, P = 0.076). The favorable outcome rate in the enoxaparin group was significantly higher than in the placebo group (57.7% vs. 25.9%, P = 0.019). CONCLUSIONS: This study showed that the early administration of enoxaparin could lead to favorable outcomes in severe TBI patients without significantly increasing cerebral hemorrhagic complications.

Malignant Cerebral Venous Infarction: Decompressive Craniectomy versus Medical Treatment.

BACKGROUND: Cerebral venous thrombosis (CVT) is a common type of stroke in young adults and associated with 8% mortality. High intracranial pressure (ICP) and brain herniation are the most common causes of death in these patients. In contrast with malignant arterial middle cerebral infarction, there are few studies reporting the efficacy of decompressive craniectomy (DC) for treatment of high ICP in patients with CVT. In this study, we assess the clinical outcome of patients with CVT with impending brain herniation treated with DC versus medical management. METHODS: In this retrospective study, medical records of all patients with CVT admitted to our hospital were reviewed. Patients with the following inclusion criteria were entered into the study: 1) CVT proven by contrast-enhanced magnetic resonance venogram and/or computed tomography venogram, 2) malignant CVT (impending brain herniation according to imaging and clinical finding), and 3) age between 16 and 80 years. Patients with deep venous system thrombosis, Glasgow Coma Scale (GCS) score of 3, and bilateral nonreactive midposition pupils or mydriasis on admission were excluded. Patients were classified into 2 groups: surgical group (DC group) including patients who received medical treatment and DC and medical group (MG) including patients who received only medical treatment. Outcomes and complications were assessed and compared between the 2 groups. RESULTS: Of 357 patients with CVT hospitalized in our center, 48 patients entered into the study. Twenty-three patients were managed medically, and 25 patients were managed surgically. There was no significant difference between the groups concerning age, sex, presenting symptoms, transient and permanent risk factors of CVT, GCS score on admission, and pupils' reactivity on admission. All patients in the MG died during hospitalization in comparison with 8 patients in the DC group (100% vs. 32%, P < 0.001). Favorable outcome (modified Rankin scale score 0-2) was achieved in 52% of the DC group and 0% of the MG group (P < 0.001). CONCLUSIONS: The results of our study confirmed that in contrast with DC, medical treatment could not prevent transtentorial herniation. DC is not only lifesaving for patients with CVT with impending brain herniation but also results in favorable outcome in most patients.

Predictive Value of Computed Tomography Scan for Posterior Ligamentous Complex Injuries in Patients with Thoracolumbar Spinal Fractures.

BACKGROUND: Thoracolumbar spinal fractures include a range of injuries of various severities from simple apophyseal fractures to neurological injury and complex fractures associated with vertebral dislocation. The treatment of thoracolumbar fractures is challenging, especially due to the difficulty of evaluating the posterior ligamentous complex (PLC). The purpose of this study was to evaluate the diagnostic value of computed tomography (CT) scan in predicting PLC injuries in the patients with thoracolumbar spinal fractures referring to the referral center of spinal trauma in the east north of Iran in 2016. METHODS: This retrospective study was conducted on patients with thoracolumbar injuries referring to Shahid Kamyab Hospital in Mashhad, east north of Iran, in 2016. The data were collected by entering the data of medical records into special forms. The classification of spinal fractures was accomplished using the AO Spine Classification System. RESULTS: According to the results, 71 (71.7%) patients were male, and the subjects had a mean age of 44.6±17.7 years. The PLC injury was observed in 28 (28.3%) patients. The PLC injury showed a significant relationship with facet joint widening, increased interspinous process distance, and spinous process avulsion fracture (P<0.05). CONCLUSION: As the findings of this study indicated, the diagnostic results of PLC injury by means of CT scan was similar to those obtained by magnetic resonance imaging in patients with thoracolumbar spinal fractures.

Spinal Intradural Primary Malignant Peripheral Nerve Sheath Tumor with Leptomeningeal Seeding: Case Report and Literature Review.

Spinal intradural primary malignant peripheral nerve sheath tumors (MPNST) are rare in patients without neurofibromatosis. Here we represent a 3-year-old girl of primary intradural spinal malignant peripheral nerve sheath tumor. The tumor was removed partially and MPNST was diagnosed in the histopathological examination. Her condition deteriorated due to acute hydrocephalus in the following days. In this article, we discuss the clinical presentation, imaging, treatment, and prognosis of our patient and the other 22 patients of primary intradural MPNST, found in the literature. The Kaplan?Meier method was applied for univariate analysis and Cox proportional hazards model for multivariate analysis. This analysis showed that age, was an important factor predicting short-term survival of patients with MPNST.

Clinical Outcomes after Microdiscectomy for Recurrent Lumbar Disk Herniation: A Single-Center Study.

BACKGROUND: Revision discectomy is the principal procedure for recurrent lumbar disk herniation (RLDH). The clinical outcomes after this procedure are as good as or slightly poorer than those produced by primary discectomy. In this study, the clinical outcomes of patients treated with microsurgical discectomy for RLDH were analyzed. METHODS: We examined 179 patients undergoing lumbar microdiscectomy surgery for RLDH. The visual analogue scale (VAS), Prolo scoring system, and Oswestry Disability Index (ODI) were used for evaluating the improvement of symptoms and functional outcomes. RESULTS: Among 179 patients, 101 (56%) obtained good and excellent Prolo scores (group 1), while 78 (44%) obtained fair or poor results (group 2). There was no significant difference between the groups regarding age (P=0.515), gender (P=0.545), body mass index (P=0.523), diabetes mellitus (P=0.074), smoking (P=0.100), interval between primary and revision surgeries (P=0.749), and surgical outcomes (P=0. 749). However, significant improvements were achieved in VAS scores for back (P=0.197) and radicular pain (P=0.606), as well as ODI scores (P= 0.000). Based on the findings, only ODI scores showed a significant inter-group difference in the 12-month follow-up (P=0.038). CONCLUSION: Limited microsurgical discectomy could be considered as the main surgical method in patients with RLDH without overt instabilities.

Endovascular treatment of an unruptured anterior communicating artery aneurysm presenting with acute altitudinal visual field defect: A case report.

PURPOSE: To describe a case of endovascular occlusion of an unruptured anterior communicating artery aneurysm presenting with acute altitudinal visual field defect is presented here. METHODS: A 52-year-old man was evaluated and treated for altitudinal visual field defect in the right eye. RESULTS: In ophthalmic and neuro-imaging, an accompanying anterior communication artery aneurysm was detected as a cause of visual field defect. He underwent endovascular procedure, yielding excellent outcome as full recovery of visual field defect was observed one month following the procedure and sustained when followed at month 24. CONCLUSIONS: Visual dysfunction is a rare presentation of unruptured anterior communication artery aneurysm. Endovascular procedure may be a safe treatment in these cases.

The effect of fresh frozen plasma in severe closed head injury.

OBJECTIVE: Traumatic brain injury (TBI) is one of the most common causes of morbidity and mortality. Coagulopathy, commonly occurring after severe TBI, is associated with poor outcome and secondary complications, especially delayed traumatic intracerebral hematoma (DTICH). In this study we evaluated the effect of fresh frozen plasma (FFP) on the reduction in the incidence of DTICH in severe closed head injury victims. METHODS: This study was carried out as a double-blind randomized clinical trial. Ninety patients were entered in two parallel groups taking either FFP or normal saline (N/S). Patients' selection criteria for both groups were: severe closed head injury (Glasgow coma scale < or =8), no mass lesion required evacuation and no history of coagulopathy. The clinical findings, laboratory data, computed tomography (CT) scans and Glasgow outcome scale after 1 month were assessed and compared in two groups. RESULTS: Out of 90 patients, 44 received FFP and 46 received N/S. The development of new intracerebral hematoma in follow-up CT scans were more common in the FFP group than the N/S group (p=0.012). Both groups showed similar frequency of poor outcome (p=0.343). The mortality was significantly more common in the FFP group than in the N/S group (63% versus 35%, p=0.006). CONCLUSION: The result of this study revealed that early empirical infusion of FFP in patients with severe head injury may lead to adverse effects, such as an increase in the frequency of DTICH and an increase in the mortality.