Prophylactic administration of tranexamic acid combined with thromboelastography-guided hemostatic algorithm reduces allogeneic transfusion requirements during pediatric resective epilepsy surgery: A randomized controlled trial
Frontiers in pharmacology. 2022;13:916017
Background: Intraoperative bleeding and allogeneic transfusion remain common problems in pediatric resective epilepsy surgery. Tranexamic acid (TXA) is a widely recommended antifibrinolytic drug that reduces blood loss and transfusion requirements for bleeding patients. Thromboelastography (TEG)-guided hemostatic algorithm is commonly used in bleeding management. This trial was designed to validate the efficacy of a multimodal coagulation therapy involving continuous TXA infusion with TEG-guided hemostatic algorithm in reducing allogeneic exposure risk in pediatric resective epilepsy surgery. Methods: Eighty-three children undergoing resective epilepsy surgery were randomized into a treatment group (Group T; n = 42) and a control group (Group C; n = 41). Group T received prophylactic TXA (10 mg/kg followed by 5 mg/kg/h) with TEG-guided hemostatic algorithm, whereas Group C received conventional coagulation management. The primary outcome was allogeneic transfusion rate during surgery, and the secondary outcomes were intraoperative blood loss, incidence of postoperative seizures, and thromboembolic events during hospitalization. Results: The incidence of intraoperative allogeneic transfusion reduced by 34.7% with the use of a multimodal coagulation therapy (19.0% in Group T vs. 53.7% in Group C; RR 0.355, 95% CI 0.179-0.704; p = 0.001). This was mainly triggered by a significant reduction (44.1%) in intraoperative plasma transfusion (7.1% in Group T vs. 51.2% in Group C; RR 0.139, 95% CI 0.045-0.432; p = 0.000). The risk of intraoperative RBC transfusion was lower in Group T than in Group C, but the difference was not statistically significant (14.3% in Group T vs. 29.3% in Group C; RR 0.488, 95% CI 0.202-1.177; p = 0.098). No platelets were transfused in both groups. Further, 19 (45.2%) patients in Group T received fibrinogen concentrates guided by TEG data, whereas 1 (2.4%) patient in Group C received fibrinogen concentrates empirically. There were no significant differences in estimated blood loss and postoperative seizures between the two groups, and no thromboembolic events were observed after surgery. Conclusion: Prophylactic administration of TXA combined with TEG-guided hemostatic algorithm can be an effective multimodal coagulation strategy for reducing allogeneic transfusion requirements during pediatric resective epilepsy surgery. Clinical Trial Registration: www.chictr.org.cn/index.aspx, identifier ChiCTR1800016188.
A systematic literature review of frequency of vaso-occlusive crises in sickle cell disease
Orphanet journal of rare diseases. 2021;16(1):460
BACKGROUND AND PURPOSE Sickle cell disease (SCD) is a collection of rare inherited blood disorders affecting approximately 100,000 people in the U.S. and 20-25 million people globally. Individuals with SCD experience recurrent episodes of severe and unpredictable pain that are caused by vaso-occlusive crises (VOCs), a hallmark of the disease. VOCs are the primary cause of hospitalization in SCD, result in missed workdays and school days, and decrease quality of life (QoL). Although VOCs cause significant burden in the lives of individuals with SCD, there is no synthesis on the frequency of VOCs in the real world. This systematic literature review sought to identify literature describing the frequency of VOCs experienced by individuals with SCD in real-world settings. METHODS MEDLINE and 6 congresses were searched (date range: January 1, 2000 to June 30, 2020). Studies were reviewed independently by two researchers. Studies assessing frequency or prevalence of VOCs or VOC-related outcomes were included. RESULTS Of 1438 studies identified in the search, 52 met pre-specified inclusion and exclusion criteria. Reported frequency of VOCs varied widely ranging from a mean or median of 0 VOCs/year to 18.2 VOCs/year. The proportion of patients experiencing ≥ 3 VOCs/year ranged from 4 to 67% and the proportion of patients experiencing ≥ 5 VOCs/year ranged from 18 to 59%. Measures of VOC severity were limited, with 13 studies considering frequency of complicated VOCs and only 1 study reporting duration of VOC episodes. CONCLUSIONS This is the first study to systematically assess published evidence pertaining to VOCs in real-world settings. Reported VOC frequency in real-world settings varied widely, with a majority of studies only considering VOCs managed in an inpatient or outpatient setting. Studies that considered VOCs managed at home reported a higher frequency of VOCs, suggesting that many studies may underestimate the frequency of VOCs. This systematic literature review (SLR) highlights the need for consistent reporting of (1) self-reported VOCs, including those managed at home, (2) definitions of VOCs, (3) complicated VOCs, and (4) duration of VOC episodes in literature.
Efficacy of Platelet-rich Plasma for Low Back Pain: A Systematic Review and Meta-analysis
J Neurol Surg A Cent Eur Neurosurg. 2020
BACKGROUND Platelet-rich plasma (PRP) may be beneficial for patients with low back pain. However, the results remain controversial. We conducted a systematic review and meta-analysis to explore the efficacy of PRP for low back pain. METHODS PubMed, Embase, Web of Science, EBSCO, and Cochrane Library databases were searched systematically. Randomized controlled trials (RCTs) assessing the effect of PRP on low back pain were included. Two investigators independently searched articles, extracted data, and assessed the quality of included studies. The primary outcome was pain scores within 8 weeks. Meta-analysis was performed using the random-effects model. RESULTS Three RCTs involving 131 patients were included in the meta-analysis. Overall, compared with control intervention for low back pain, PRP injection was found to reduce pain scores significantly (mean difference: - 1.47; 95% confidence interval [CI], - 2.12 to - 0.81; p < 0.0001), improve the number of patients with > 50% pain relief at 3 months (risk ratio [RR]: 4.14; 95% CI, 2.22-7.74; p < 0.00001), and offer relatively good patient satisfaction (RR: 1.91; 95% CI, 1.04-3.53; p = 0.04). No increase in adverse events was reported after PRP injection (RR: 1.92; 95% CI, 0.94-3.91; p = 0.07). CONCLUSIONS Compared with control intervention for low back pain, PRP injection was found to improve pain relief and patient satisfaction significantly with no increase in adverse events.
Role of Xingnaojing Injection in treating acute cerebral hemorrhage: A systematic review and meta-analysis
Medicine (Baltimore). 2020;99(15):e19648
BACKGROUND Xingnaojing injection (XNJi) is widely used for acute cerebral hemorrhage. However, the efficacy of XNJi for acute cerebral hemorrhage has not been comprehensively proved by systematic analysis yet. Therefore, it is essential to evaluate the efficacy and safety of XNJi in an evidence-based method. METHODS Six databases were searched with XNJi used for acute cerebral hemorrhage in randomized controlled trials (RCTs). Meta-analysis was performed by Review Manager 5.3. The efficacy rate, brain edema, cerebral hematoma, neurological deficit score, hs-crp, Glasgow Coma Scale (GCS), and activities of daily living (ADL) were systematically evaluated. The Cochrane risk of bias was used to evaluate the methodological quality of eligible studies. RESULTS This study is registered with PROSPERO (CRD42018098737). Twenty-nine studies with a total of 2638 patients were included in this meta-analysis. Compared with conventional treatment, XNJi got higher efficacy rate (OR = 3.37, 95% CI [2.65, 4.28], P < .00001). Moreover, XNJi showed significant enhancement of efficacy rate via subgroup analysis in course and dosage. In addition, XNJi demonstrated significant improvement in Chinese stroke scale (CSS) and National Institutes of Health Stroke Scale (NHISS) (mean difference [MD] = -4.74, 95% CI [-5.89, -3.60], P < .00001; MD = -4.45, 95% CI [-5.49, -3.41], P < .00001), GCS (MD = 2.72, 95% CI [2.09, 3.35], P < .00001). It also remarkably decreased the level of hs-crp (MD = -6.50, 95% CI [-7.79, -5.21], P < .00001), enhanced ADL (MD = 20.38, 95% CI [17.98, 22.79], P < .00001), and alleviated hematoma and edema (MD = -2.53, 95% CI [-4.75, -0.31] P < .05; MD = -1.74 95% CI [-2.42, -1.07] P < .00001) compared with conventional treatment. CONCLUSION XNJi is effective in treating acute cerebral hemorrhage with significant improvement of CSS, NHISS and impairment of hs-crp, hematoma, and edema compared with conventional treatment. Moreover, XNJi got remarkable efficacy at the dose of 20, 30, 60 mL and from 7 to 28 days. No serious adverse reactions occurred. These results were mainly based on small-sample and low-quality studies. Therefore, more rigorous, large-scale RCTs were further needed to confirm its efficacy, safety, and detailed characteristic of application.
Prevalence of hepatitis G virus infection among 67,348 blood donors in mainland China
BMC public health. 2019;19(1):685
BACKGROUND Hepatitis G virus (HGV) infection transmitted from blood donors is a concern in China, as many articles about HGV infection in Chinese blood donors from different provinces have been published. This study aimed to evaluate the overall prevalence of HGV infection in Chinese blood donors and analyse the potential risk of HGV infection through blood transfusion in China. METHODS We performed a literature search in PubMed, EMBASE, Web of Science, the Chinese BioMedical Literature Database (CBM) and the China National Knowledge Infrastructure (CNKI) up to October 2018 regarding the prevalence of HGV in Chinese blood donors. Eligibility assessment and data extraction were conducted independently by 2 researchers, and meta-analysis was performed to synthesize the data. Heterogeneity was evaluated using Cochran's Q test and quantified using the I(2) statistic. Subgroup analyses were performed to identify the possible sources of heterogeneity. Publication bias was assessed using both funnel plot and Egger's tests. RESULTS A total of 102 studies with 67,348 blood donors published from 1996 to 2016 and covering 26 provinces or municipalities were included for further analyses. The pooled prevalence of HGV was 3.91% (95%CI: 3.18-4.71%) by enzyme immune assay/enzyme linked immunosorbent assay (EIA/ELISA) and 3.25% (95%CI: 2.35-4.26%) by polymerase chain reaction (PCR). The prevalence of HGV may be significantly affected by region, province or municipality and potentially by the paid/voluntary status of the blood donors. No significant difference was found between plasma and full blood donation. CONCLUSIONS The prevalence of HGV in blood donors from China was similar to that in blood donors from many other countries and higher than that of some other hepatitis viruses, such as hepatitis B virus. The risk of transfusion-transmitted HGV still exists after routine blood donor screening, especially in those patients coinfected with other hepatitis viruses and/or HIV. On the basis of our study, we may suggest adding HGV screening for blood transfusions in mainland China in the future.
Comparison of intramedullary and extramedullary fixation of stable intertrochanteric fractures in the elderly: a prospective randomised controlled trial exploring hidden perioperative blood loss
Bmc Musculoskeletal Disorders. 2016;17((1)):475.
BACKGROUND Hip fracture is a severe and common injury that occurs predominantly in the elderly. Blood loss in the perioperative period is associated with a greater risk of dying in anaemic patients. The aim of the study was to explore the best way to treat stable intertrochanteric fractures, taking hidden blood loss into account. METHODS This prospective, randomised blinded study included patients aged over 65 years with stable intertrochanteric fractures (Evans grades I and II). The patients were allocated to one of two groups treated via extramedullary or intramedullary fixation. Patient data were retrieved from electronic charts. Functional recovery was evaluated using the Functional Recovery Score of Zuckerman. Postoperative complications were also recorded. The formula of Nadler and Gross was used to calculate blood loss. RESULTS There were 92 patients in the extramedullary and 106 in the intramedullary group. Age, sex, the cause of injury, the type of fracture, the observed blood loss, functional recovery, time to union, complications, and American Society of Anesthesiologists classification did not differ significantly between the two groups (all p-values > 0.05). The frequencies of lung infection, electrolyte imbalance, and hypoproteinemia differed between groups (all p-values < 0.05). Total and hidden blood loss were higher in the intramedullary group (p = 0.001). CONCLUSION Extramedullary (compared with intramedullary) fixation of stable intertrochanteric fractures significantly reduces perioperative blood loss but affords similar functional outcomes and times to union. In view of the morbidity and complications associated with acute anaemia and transfusions, extramedullary fixation may be the optimal choice for treatment of stable fractures, being associated with reduced blood loss. TRIAL REGISTRATION The study was retrospectively registered at the Chinese Clinical Trial Registry, number: ChiCTR-INQ-16009754 , trial registration date: 6th Nov. 2016.
Hemostatic effect of topical hemocoagulase spray in digestive endoscopy
World Journal of Gastroenterology. 2016;22((25)):5831-6.
AIM: To evaluate the hemostatic effect of topical hemocoagulase spray in digestive endoscopy. METHODS Eighty-nine patients who developed oozing bleeding during endoscopic treatment from September 2014 to October 2014 at Center for Digestive Endoscopy, Tianjin Medical University General Hospital were randomly divided into either a study group (n = 39) or a control group (n = 50). The study group was given topical hemocoagulase spray intraoperatively, while the control group was given traditional 8% norepinephrine spray. Hemostatic efficacy was compared between the two groups. Bleeding site, wound cleanliness and perforation were recorded, and the rates of perforation and late bleeding were compared. RESULTS Successful hemostasis was achieved in 39 (100%) patients of the study group and in 47 (94.0%) patients of the control group, and there was no significant difference in the rate of successful hemostasis between the two groups. Compared with the control group, after topical hemocoagulase spray in the study group, the surgical field was clearer, the bleeding site was more easily identified, and the wound was cleaner. There was no significant difference in the rate of perforation between the study and control groups (16.7% vs 35.0%, P = 0.477), but the rates of late bleeding (0% vs 15.8%, P = 0.048) and overall complications (P = 0.032) were significantly lower in the study group. CONCLUSION Topical hemocoagulase spray has a definite hemostatic effect for oozing bleeding in digestive endoscopy, and this method is convenient, safe, and reliable. It is expected to become a new method for endoscopic hemostasis.
Perioperative blood transfusion is associated with worse clinical outcomes in resected lung cancer
Annals of Thoracic Surgery. 2014;97((5):):1827-37.
The deleterious effect of perioperative allogeneic blood transfusion in patients with resected lung cancer has been controversial. We conducted this meta-analysis to answer the question of whether perioperative allogeneic blood transfusion adversely affects recurrence and survival in patients with resected lung cancer. Included were 23 studies with 6,474 patients. The result showed allogeneic blood transfusion was significantly associated with earlier recurrence and worse survival in patients with surgically resected lung cancer. We suggest transfusion policy should be stricter in lung cancer patients undergoing resection, especially with early-stage disease. Prospective large-scale studies are still warranted. Copyright 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
A randomised, double-blind, sham-controlled study of granulocyte/monocyte apheresis for moderate to severe Crohn's disease
OBJECTIVES Activated granulocytes and monocytes may contribute to the pathogenesis of Crohn's disease (CD). In small, uncontrolled studies, granulocyte/monocyte apheresis (GMA) has shown promise in treating CD. We conducted a randomised, double-blind study to compare GMA with a sham procedure in patients with moderate to severe CD. DESIGN Patients with active CD as defined by a Crohn's Disease Activity Index (CDAI) of 220-450 were randomly allocated in a 2:1 ratio to treatment with GMA using the Adacolumn Apheresis System (JIMRO, Takasaki, Japan) or sham apheresis. Ten apheresis sessions were scheduled over a 9-week period, and efficacy was evaluated at week 12. The primary end point was the proportion of patients achieving clinical remission (CDAI score =150 without use of prohibited drugs). RESULTS Clinical remission was achieved by 17.8% of patients in the GMA group (n=157) compared with 19.2% of those in the sham control group (n=78) (absolute difference -1.4% (95% CI-12.8% to 8.5%), p=0.858). Clinical response (defined as a =100-point decrease in CDAI) was achieved by 28.0% and 26.9% of patients in the GMA and sham groups, respectively (p=1.000). The two treatments produced similar changes from baseline in CDAI and quality of life, as well as in disease severity assessed endoscopically. The incidence and types of adverse events did not differ between groups. CONCLUSIONS GMA was well tolerated, but this study did not demonstrate its effectiveness over a sham procedure in inducing clinical remission or response in patients with moderate to severe CD. CLINICAL TRIAL REGISTRATION NUMBER Clinical Trials.gov identifier NCT00162942.
A randomized, double-blind, sham-controlled study of granulocyte/monocyte apheresis for active ulcerative colitis
BACKGROUND & AIMS Activated granulocytes and monocytes/macrophages are implicated in the pathogenesis of ulcerative colitis. Open-label studies and clinical experience in Japan and Europe have suggested that granulocyte/monocyte apheresis is safe and effective in treating ulcerative colitis. METHODS We evaluated the efficacy of granulocyte/monocyte apheresis in a randomized, double-blind, sham-controlled trial in patients with active moderate-to-severe ulcerative colitis (Mayo score 6-11) in community-based and tertiary care centers. As intervention, we used granulocyte/monocyte apheresis with the Adacolumn Apheresis System (JIMRO, Ltd, Takasaki, Japan) or sham apheresis in a 2:1 ratio for 9 weeks of treatment in a North American pivotal study (N = 168) and in a smaller, companion study of identical design conducted in Europe and Japan (N = 47). RESULTS In the pivotal study, clinical remission rates (Mayo score 0-2, with scores of 0 on rectal bleeding and 0 or 1 on endoscopic examination) were 17% and 11% for the granulocyte/monocyte apheresis (n = 112)- and sham-treatment groups, respectively (n = 56; P = . 361). Clinical response (Mayo score reduction of ≥3 points from baseline) was observed in 44% and 39% of patients, respectively (P = . 620). Similar changes were observed for the apheresis- and sham-treatment groups for endoscopic remission and response, and changes in Mayo and quality-of-life scores. The companion study and pooled data from both studies also yielded similar results. CONCLUSIONS In this study, granulocyte/monocyte apheresis was well tolerated but did not demonstrate efficacy for induction of clinical remission or response in patients with moderate-to-severe ulcerative colitis.