Safety and Short-term Outcomes of High-Dose Erythropoietin in Preterm Infants With Intraventricular Hemorrhage: The EpoRepair Randomized Clinical Trial
JAMA network open. 2022;5(12):e2244744
IMPORTANCE Intraventricular hemorrhage (IVH) is a major cause of neonatal morbidity and mortality in preterm infants without a specific medical treatment to date. OBJECTIVE To assess the safety and short-term outcomes of high-dose erythropoietin in preterm infants with IVH. DESIGN, SETTING, AND PARTICIPANTS Between April 1, 2014, and August 3, 2018, a randomized double-blind clinical trial enrolled 121 preterm infants (gestational age <32 weeks or birth weight <1500 g) aged 8 or less days with moderate to severe IVH identified by cerebral ultrasonography from 8 Swiss and Austrian tertiary neonatal units. Statistical analyses were performed between October 1, 2019, and September 12, 2022. INTERVENTIONS Infants received intravenous high-dose erythropoietin (2000 units/kg body weight) or placebo at 4 time points between weeks 1 and 4 of life. MAIN OUTCOMES AND MEASURES Secondary outcomes included (1) mortality and morbidity rates and (2) brain magnetic resonance imaging findings at term-equivalent age (TEA). The primary outcome was the composite intelligence quotient at 5 years of age (not available before 2023). RESULTS Sixty infants (48% male [n = 29]) were randomly assigned to receive erythropoietin, and 61 infants (61% male [n = 37]) were randomly assigned to receive placebo. The median birth weight was 832 g (IQR, 687-990 g) in the erythropoietin group and 870 g (IQR, 680-1110 g) in the placebo group. Median gestation was 26.1 weeks (IQR, 24.8-27.3 weeks) in the erythropoietin group and 27.0 weeks (24.9-28.1 weeks) in the placebo group. The 2 groups had similar baseline characteristics and morbidities. Up to TEA, 10 newborns died (16.7%) in the erythropoietin group, and 5 newborns (8.2%) died in the placebo group (adjusted odds ratio, 2.24 [95% CI, 0.74-7.66]; P = .15). Infants receiving erythropoietin had higher mean hematocrit levels. Conventional magnetic resonance imaging at TEA for 100 infants showed no significant differences in global or regional brain injury scores. CONCLUSIONS AND RELEVANCE This preliminary report of a randomized clinical trial found no evidence that high-dose erythropoietin in preterm infants with IVH affects brain injury scores on conventional magnetic resonance imaging at TEA. Higher mortality in the erythropoietin group was not significant but should be reassessed based on future results from similar trials. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02076373.
Preterm infants with intraventricular haemorrhage enrolled in the EpoRepair trial, in 8 Swiss and Austrian tertiary neonatal units (n= 121).
Intravenous high-dose erythropoietin (n= 60).
Placebo (n= 61).
The median birth weight was 832 g (IQR, 687-990 g) in the erythropoietin group and 870 g (IQR, 680-1110 g) in the placebo group. Median gestation was 26.1 weeks (IQR, 24.8-27.3 weeks) in the erythropoietin group and 27.0 weeks (24.9-28.1 weeks) in the placebo group. Both groups had similar baseline characteristics and morbidities. Up to term-equivalent age (TEA), 10 newborns died (16.7%) in the erythropoietin group, and 5 newborns (8.2%) died in the placebo group (adjusted odds ratio, 2.24 (95% CI 0.74 to 7.66)). Infants receiving erythropoietin had higher mean haematocrit levels. Conventional magnetic resonance imaging at TEA for 100 infants showed no significant differences in global or regional brain injury scores.
Systematic Review of Resource Utilization and Costs in the Hospital Management of Intracerebral Hemorrhage
World neurosurgery. 2022
BACKGROUND While clinical guidelines provide a framework for hospital management of spontaneous intracerebral hemorrhage (ICH), variation in the resource utilization and costs of these services exist. OBJECTIVES Perform a systematic literature review to assess the evidence on hospital resource utilization and costs associated with management of adult ICH patients, as well as identify factors that impact variation in such hospital resource utilization and costs, regarding clinical characteristics and delivery of services. METHODS A systematic literature review was performed using PubMed, Cochrane Central Register of Controlled Trials, and Ovid MEDLINE(R) 1946 to Present. Articles were assessed against inclusion and exclusion criteria. Study design, ICH sample size, population, setting, objective, hospital characteristics, hospital resource utilization and cost data, and main study findings were abstracted. RESULTS 43 studies met the inclusion criteria. Pertinent clinical characteristics that increased hospital resource use included presence of comorbidities and baseline ICH severity. Aspects of service delivery that greatly impacted hospital resource consumption included ICU length of stay and performance of surgical procedures and intensive care procedures. CONCLUSION Hospital resource utilization and costs for ICH patients were high and differed widely across studies. Making concrete conclusions on hospital resources and costs for ICH care was constrained given methodological and patient variation in the studies. Future research should evaluate the long-term cost-effectiveness of ICH treatment interventions and use specific economic evaluation guidelines and common data elements to mitigate study variation.
Platelet Rich Plasma and Platelet-Related Products in the Treatment of Radiculopathy-A Systematic Review of the Literature
Back pain with radicular symptoms is associated with detrimental physical and emotional functioning and economic burden. Conservative treatments including physical, pharmacologic and injection therapy may not provide clinically significant or long-standing relief. Regenerative medicine research including Platelet rich plasma (PRP), Platelet lysate (PL) or Plasma rich in growth factors (PRGF) continues to develop, however evidence appraisal for treatment of radicular pain remains lacking. Thus, we performed a systematic review to evaluate the effectiveness of epidural steroid injections containing PRP or related products to treat radicular pain. Embase, PubMed/MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar databases were queried. Twelve studies were included in qualitative analysis, consisting of three randomized controlled trials and nine observational studies. The primary outcome was pain intensity, and secondary outcomes included functional improvement, anatomical changes on advanced imaging, and adverse events. All studies identified improved pain intensity and functional outcomes after epidural injection of PRP, PRGF and/or PL. Similar or longer lasting pain relief was noted in the PRP cohort compared to the cohort receiving epidural steroid injections with effects lasting up to 12-24 months. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) analysis revealed a very-low certainty of evidence due to risk of bias, indirectness, and imprecision.
Postoperative Transfusion Guidelines in Aneurysmal Cerebral Subarachnoid Hemorrhage: A Systematic Review and Critical Summary of Available Evidence
World Neurosurgery. 2022;158:234-243.e5
OBJECTIVE Surgical management of aneurysmal subarachnoid hemorrhage (SAH) often involves red blood cell (RBC) transfusion, which increases the risk of postoperative complications. RBC transfusion guidelines report on chronically critically ill patients and may not apply to patients with SAH. Our study aims to synthesize the evidence to recommend RBC transfusion thresholds among adult patients with SAH undergoing surgery. METHODS A systematic review was conducted using PubMed, Google Scholar, and Web of Science electronic databases according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines to critically assess primary articles discussing RBC transfusion thresholds and describe complications secondary to RBC transfusion in adult patients with SAH in the perioperative period. RESULTS Sixteen articles meeting our search strategy were reviewed. Patients with SAH who received blood transfusion were older, female, had World Federation of Neurosurgical Societies grade IV-V and modified Fisher grade 3-4 scores, and presented with more comorbidities such as hypertension, diabetes, and cardiovascular and pulmonary diseases. In addition, transfusion was associated with multiple postoperative complications, including higher rates of vasospasms, surgical site infections, cardiovascular and respiratory complications, increased postoperative length of stay, and 30-day mortality. Analysis of transfused patients showed that a higher hemoglobin (>10 g/dL) goal after SAH was safe and that patients may benefit from a higher whole hospital stay hemoglobin nadir, as shown by a reduction in risk of cerebral vasospasm and improvement in clinical outcomes (level B class II). CONCLUSIONS Among patients with SAH, the benefits of reducing cerebral ischemia and anemia are shown to outweigh the risks of transfusion-related complications.
Observation on the effect of platelet-rich plasma combined with drugs in the treatment of herpes zoster neuralgia
The International journal of neuroscience. 2022;:1-11
Purpose: To observe the effect of ultrasound-guided platelet-rich plasma (PRP) injection in the treatment of herpes zoster neuralgia (HZN).Methods: Eighty patients with HZN were randomly divided into observation group and control group, with 40 cases in each group. The observation group was treated with ultrasound-guided PRP injection of target nerves combined with drugs. The control group was treated with drugs alone. The pain scores of before treatment (T0), and 1 week (T1), 1 month (T2), 3 months (T3) and 6 months (T4) after treatment were recorded with Numerical Rating Scale (NRS). The sleep quality of patients was assessed with the Athens Insomnia Scale, and the dosage used at each time point, skin lesions, adverse reactions, and the occurrence of postherpetic neuralgia (PHN) were recorded.Results: The NRS score of the two groups after treatment showed a downward trend. Compared with T0 at each time point, the difference was statistically significant (P < 0.05). And the NRS score of the observation group was lower than control group (P < 0.05). The sleep quality of the observation group was better. The dosage of the observation group was less, and the time of herpes dry-up, scab crusting and shedding in the observation group was significantly shorter (P < 0.05). The incidence of dizziness, lethargy, ataxia and PHN in the observation group was significantly reduced (P < 0.05).Conclusion: Compared with traditional drug treatment alone, the ultrasound-guided PRP injection has the advantages of better analgesia and fewer side effects, which provides a new idea for the treatment of HZN.
Efficacy of Local Autologous Platelet-Rich Plasma in the Treatment of Pressure Ulcer in Spinal Cord Injury Patients
BACKGROUND Pressure ulcer is one of the common complications occurring in spinal cord injury (SCI) patients. Platelet-rich plasma (PRP) has been found useful in the treatment of pressure ulcers in few studies. The purpose of this study was to evaluate the role of PRP in pressure ulcer healing in comparison to hydrogel dressing in SCI patients. METHODS In this randomized interventional study, 52 patients of SCI having pressure ulcers of grade III/IV were randomized into two groups of 26 each. In group A patients, hydrogel dressing was done while freshly prepared PRP was used in patients of group B. Pressure ulcers were evaluated at baseline and after three weeks and six weeks in terms of ulcer surface area, volume, Pressure Ulcer Scale for Healing (PUSH) score, histopathology, and ulcer healing parameters. Data were collected and quantitative variables were compared using unpaired t-test or Mann-Whitney test between the two groups and qualitative variables were compared using the chi-square test or Fisher's exact test. A p-value of <0.05 was considered statistically significant. RESULTS Baseline characteristics were comparable in both groups. There was a significant improvement in ulcers in terms of surface area, volume, and PUSH score in both the groups but it was comparable (p-value >0.05). There was a significant improvement in the PRP group as compared to the other group in terms of epithelization, granulation, and neovascularization at three and six-week follow-up. CONCLUSIONS This study suggests that PRP is a possible and better alternative to conventional dressing methods for the treatment of pressure ulcers.
Effects of ultrasound-guided platelet rich plasma injection in patients with piriformis syndrome
Journal of back and musculoskeletal rehabilitation. 2021
BACKGROUND Piriformis syndrome (PS) is the common entrapment neuropathy causing buttock pain. Patients are conventionally treated with lifestyle modification, exercise, non-steroidal anti-inflammatory drugs, corticosteroid or botulinum toxin injections. However, some patients may not respond to these conventional treatment methods. Platelet rich plasma (PRP) injection has been shown to be beneficial in various muscular injuries, but its effects have not yet been investigated in PS. OBJECTIVE The aim of this study was to explore the effect of PRP on pain and functional status in patients with PS, and to identify any correlations between clinical changes and demographic features. METHODS A total of 60 patients with PS were randomly separated into two groups (PRP and control groups). All patients received one session of either PRP or saline injection performed under ultrasound guidance. The pain was measured with a visual analog scale (VAS) and Oswestry Disability Index (ODI) scores were noted at three intervals in both groups: before treatment, 1 week after treatment and 1 month after treatment. RESULTS The VAS and ODI scores were improved in both groups. The improvement was more obvious in the PRP group in the first week, and the results were similar for both groups when measured 1 month after the treatment. CONCLUSION Ultrasound-guided PRP injection provided greater improvements in both pain and functional status in patients with PS, starting in the early period after treatment. A repeat injection might be needed for a long-term effect.
A Randomized Double-Blind Controlled Pilot Study Comparing Leucocyte-Rich Platelet-Rich Plasma and Corticosteroid in Caudal Epidural Injection for Complex Chronic Degenerative Spinal Pain
Pain Pract. 2020
OBJECTIVES To compare the efficacy and safety between leucocyte-rich platelet-rich plasma (LR-PRP) and corticosteroid in fluoroscopically guided caudal epidural injection for patients with complex chronic lumbar spinal pain. Study Design A prospective randomized controlled double blinded study METHODS Fifty eligible patients with complex chronic degenerative spinal pain were randomly assigned with 1:1 allocation ratio to receive caudal epidural injection of corticosteroid (triamcinolone acetonide, 60mg) or LR-PRP (isolated from 60 ml autologous blood) under fluoroscopic guidance. Levels of low back pain, quality of life, and complications (or adverse effects) were evaluated at 1, 3, and 6 months after treatment. Pain levels and quality of life were assessed using the visual analog scale (VAS) and short form SF-36, respectively. RESULTS No significant difference was shown at baseline between two groups. Compared with the pretreatment values, there were significant reduction in the VAS score in both groups. Significantly lower VAS score at 1-month follow-up was detected in patients who received corticosteroid injection. However, the scores were lower in the LR-PRP group at 3- and 6-month follow-up. SF-36 questionnaires measured at 6-month showed significant improvement at all domains in the LR-PRP group. There were no complications or adverse effects related with treatment during 6-month follow-up in either group. CONCLUSIONS Both autologous LR-PRP and corticosteroid for caudal epidural injections under fluoroscopic guidance are equally safe and therapeutically effective in patients with complex chronic lumbar spinal pain. However, LR-PRP is superior to corticosteroid for longer pain-relieving effect and improvement in quality of life.
The effect of platelet transfusion on functional independence and mortality after antiplatelet therapy associated spontaneous intracerebral hemorrhage: A systematic review and meta-analysis
Journal of the neurological sciences. 2020;417:117075
INTRODUCTION The practice of platelet transfusion to mitigate the deleterious effects of antiplatelet agents on spontaneous intracerebral hemorrhage (ICH) remains common. However, the effect of antiplatelet agents on patients with ICH is still controversial and transfusing platelets is not without risk. We performed a meta-analysis in order to determine the effect of platelet transfusion on antiplatelet agent associated ICH. METHODS We queried PubMed, Embase, and Scopus databases to identify cohort studies, case-control studies, and randomized control trials. Study quality was graded by the Newcastle-Ottawa Scale and Cochrane Risk of Bias tool, as appropriate. Outcomes of interest included functional independence as measured by the modified Rankin Scale and mortality. We compared patients with antiplatelet agent associated ICH who received platelet transfusion to those that did not. RESULTS We identified 625 articles. After reviewing 44 full text articles, 5 were deemed appropriate for meta-analysis, including 4 cohort studies and one randomized control trial. Considerable heterogeneity was present among the studies (I(2) > 81% for all analyses). We did not find a significant effect of platelet transfusions on functional independence (Odds Ratio [OR] 1.3, 95% CI.0.45-3.9) or mortality (OR 0.58, 95% Confidence Interval [CI] 0.12-2.6). CONCLUSION We found no evidence for an effect of platelet transfusions on functional independence or mortality following antiplatelet associated ICH. More randomized trials are needed to evaluate platelet transfusion in patients with ICH and proven reduced platelet activity or those requiring neurosurgical intervention.
Efficacy of platelet-rich plasma in the treatment of hemiplegic shoulder pain
Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology. 2020
OBJECTIVE The aim of this study was to examine the effects of platelet-rich plasma (PRP) on pain and functional outcomes in patients with hemiplegic shoulder pain. We compared the effects of PRP against saline solution by designing a double blind, randomized, prospective study. DESIGN Forty-four patients with hemiplegia were included in this study. All patients received a total of 3 injections, 1 week apart. The first group received PRP injections while the second group received placebo injections. After 3 months of follow-up, 40 patients completed the trial. Primary outcome measure was movement-induced pain score (VAS), and secondary outcome measures were spontaneous pain score, shoulder passive range of motion (ROM), functional independence measure score, and the amount of paracetamol used. All subjects were evaluated at baseline, 1 week, 1 month, and 3 months after the completion of the last injection. RESULTS Both groups showed an improvement in spontaneous and movement-related pain scores and shoulder passive ROM values on 1st and 3rd month visits (p < 0.05). No significance difference was detected between groups (p > 0.05). Similarly, FIM scores improved significantly in both groups (p < 0.05) but no difference was found between groups. Paracetamol use did not differ significantly between groups. CONCLUSION The PRP injections were found not to be superior to placebo. Improvements in both groups can be attributed to the use of rehabilitation techniques and exercises in all patients. There is still need for further research to show whether PRP is a treatment option in the course of hemiplegic shoulder pain. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03931824.