Postoperative Blood Loss Including Hidden Blood Loss in Early and Late Surgery Using Percutaneous Pedicle Screws for Traumatic Thoracolumbar Fracture.

INTRODUCTION: Some reports revealed that hidden blood loss (HBL) during surgery for traumatic thoracolumbar fracture cannot be ignored, even when using a percutaneous approach. Using percutaneous pedicle screws (PPS) for traumatic thoracolumbar fracture, this study aimed to compare estimate blood loss (EBL), including HBL, between early and late fixation. METHODS: This investigation was a retrospective study. In the present study, data from 39 patients who underwent posterior spinal stabilization using PPS for single-level thoracolumbar fracture have been included. We divided the patients into an early group (group E) (n=20) in whom surgery was conducted within 3 days of fracture and a late group (group L) (n=19) in whom surgery was conducted more than 3 days after fracture. We evaluated hemoglobin (Hb) on the day of injury, and 1, 3 or 4, and 7 days after surgery, EBL, HBL, and transfusion requirement. RESULTS: Hb on day 1 (group E: 12.2±1.7 g/dL, group L: 12.3±1.6 g/dL) was significantly less than that on the injured day (group E: 14.2±1.7 g/dL, group L: 13.9±1.7 g/dL) in both groups. The values of Hb and EBL were not significantly different at any time between the two groups. HBL (group E: 487±266 mL, group L: 386±305 mL) was not significantly different between the two groups. No patients required transfusion in either group. CONCLUSIONS: EBL in early fixation using PPS for traumatic thoracolumbar fracture is not significantly different compared with that in late surgery from days 1 to 7 postoperatively. Early fixation using PPS for traumatic thoracolumbar fracture does not result in negative outcomes any more than those in late surgery in terms of blood loss.

Randomized trial of granulocyte colony-stimulating factor for spinal cord injury.

Attenuation of the secondary injury of spinal cord injury (SCI) can suppress the spread of spinal cord tissue damage, possibly resulting in spinal cord sparing that can improve functional prognoses. Granulocyte colony-stimulating factor (G-CSF) is a haematological cytokine commonly used to treat neutropenia. Previous reports have shown that G-CSF promotes functional recovery in rodent models of SCI. Based on preclinical results, we conducted early phase clinical trials, showing safety/feasibility and suggestive efficacy. These lines of evidence demonstrate that G-CSF might have therapeutic benefits for acute SCI in humans. To confirm this efficacy and to obtain strong evidence for pharmaceutical approval of G-CSF therapy for SCI, we conducted a phase 3 clinical trial designed as a prospective, randomized, double-blinded and placebo-controlled comparative trial. The current trial included cervical SCI [severity of American Spinal Injury Association (ASIA) Impairment Scale (AIS) B or C] within 48 h after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group was administered 400 µg/m2/day × 5 days of G-CSF in normal saline via intravenous infusion for five consecutive days. The placebo group was similarly administered a placebo. Allocation was concealed between blinded evaluators of efficacy/safety and those for laboratory data, as G-CSF markedly increases white blood cell counts that can reveal patient treatment. Efficacy and safety were evaluated by blinded observer. Our primary end point was changes in ASIA motor scores from baseline to 3 months after drug administration. Each group includes 44 patients (88 total patients). Our protocol was approved by the Pharmaceuticals and Medical Device Agency in Japan and this trial is funded by the Center for Clinical Trials, Japan Medical Association. There was no significant difference in the primary end point between the G-CSF and the placebo control groups. In contrast, one of the secondary end points showed that the ASIA motor score 6 months (P = 0.062) and 1 year (P = 0.073) after drug administration tend to be higher in the G-CSF group compared with the placebo control group. Moreover, in patients aged over 65 years old, motor recovery 6 months after drug administration showed a strong trend towards a better recovery in the G-CSF treated group (P = 0.056) compared with the control group. The present trial failed to show a significant effect of G-CSF in primary end point although the subanalyses of the present trial suggested potential G-CSF benefits for specific population.

Investigation into the mobility of elderly patients with pneumonia using triaxial accelerometer data.

OBJECTIVE: This study aimed to clarify the levels of physical activity of elderly pneumonia patients. METHOD: This is a prospective observational study among pneumonia patients who were hospitalized in a clinic within a general and respiratory medicine hospital department, and community-dwelling elderly. Activity levels of 29 elderly patients with pneumonia who were aged >75 years (PP group), and 15 community-dwelling healthy elderly (CD group) were measured. Triaxial accelerometers were attached to the patients' left chest regions from 48 h until 7 days after hospitalization. RESULTS: The time spent in the upright position was 320.0 min/day in the PP group and 729.0 min/day in the CD group. The time spent walking was 3.8 min/day in the PP group, and 71.0 min/day in the CD group. In the PP group, the times spent in the upright position and walking did not increase during the period studied, that is, from 48 h until 7 days after hospitalization. CONCLUSION: The time spent in the upright position and walking among elderly patients with pneumonia did not increase, despite gradual improvement of the disease.

Study protocol for the G-SPIRIT trial: a randomised, placebo-controlled, double-blinded phase III trial of granulocyte colony-stimulating factor-mediated neuroprotection for acute spinal cord injury.

INTRODUCTION: Granulocyte colony-stimulating factor (G-CSF) is generally used for neutropaenia. Previous experimental studies revealed that G-CSF promoted neurological recovery after spinal cord injury (SCI). Next, we moved to early phase of clinical trials. In a phase I/IIa trial, no adverse events were observed. Next, we conducted a non-randomised, non-blinded, comparative trial, which suggested the efficacy of G-CSF for promoting neurological recovery. Based on those results, we are now performing a phase III trial. METHODS AND ANALYSIS: The objective of this study is to evaluate the efficacy of G-CSF for acute SCI. The study design is a prospective, multicentre, randomised, double-blinded, placebo-controlled comparative study. The current trial includes cervical SCI (severity of American Spinal Injury Association (ASIA) Impairment Scale B/C) within 48 hours after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group is administered 400 µg/m2/day×5 days of G-CSF in normal saline via intravenous infusion for 5 consecutive days. The placebo group is similarly administered a placebo. Our primary endpoint is changes in ASIA motor scores from baseline to 3 months. Each group includes 44 patients (88 total patients). ETHICS AND DISSEMINATION: The study will be conducted according to the principles of the World Medical Association Declaration of Helsinki and in accordance with the Japanese Medical Research Involving Human Subjects Act and other guidelines, regulations and Acts. Results of the clinical study will be submitted to the head of the respective clinical study site as a report after conclusion of the clinical study by the sponsor-investigator. Even if the results are not favourable despite conducting the clinical study properly, the data will be published as a paper. TRIAL REGISTRATION NUMBER: UMIN000018752.

Surgical technique for idiopathic spinal cord herniation: the Hammock method. Technical note.

Idiopathic spinal cord herniation is a rare disease, and surgical treatment is recommended for patients with motor deficits or progressive neurological symptoms. Surgery is performed to release and reposition the tethered spinal cord. In terms of repositioning and prevention of reherniation, various procedures have been proposed; enlargement of the ventral dural defect, primary closure of the defect with sutures, and insertion of a ventral patch for duraplasty. We treated 3 patients with idiopathic spinal cord herniation, using a ventral patch for duraplasty with an expanded polytetrafluoroethylene pericardial membrane (the Hammock method), and all 3 cases had good clinical outcome. The specific important technical aspects are described and illustrated. If this procedure is performed meticulously under the microscope by following the specific techniques, the Hammock method is safer and more effective for prevention of reherniation than simple enlargement of the dural defect.