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Effect and Safety of Diluted Vasopressin Injection for Bleeding Control During Robot-assisted Laparoscopic Myomectomy in Reproductive Women With Uterine Fibroids: A Randomized Controlled Pilot Trial (VALENTINE Trial)
Park, S. J., Lee, J. W., Hwang, D. W., Lee, S., Yim, G. W., Song, G., Lee, E. J., Kim, H. S.
In vivo (Athens, Greece). 2024;38(1):431-436
Abstract
BACKGROUND/AIM: Vasopressin injected during myomectomy is known to effectively reduce bleeding but is sometimes associated with intraoperative vasoconstriction and hypertension due to systemic absorption. Although there is a growing preference for the use of diluted vasopressin, evidence of its effect and safety is still lacking. PATIENTS AND METHODS We performed a randomized controlled pilot trial to evaluate the effect and safety of vasopressin diluted in a constant volume during robot-assisted laparoscopic myomectomy (RALM), where a total of 39 women with uterine fibroids were randomly assigned into the following three groups (group 1, 0.2 IU/ml; group 2, 0.1 IU/ml; group 3, 0.05 IU/ml with a total of 100 ml of normal saline). The primary endpoint was to compare estimated blood loss (EBL), and the secondary endpoints were to compare postoperative value and drop ratio of hemoglobin, operation time, transfusion, hospitalization, and complications among the three groups. RESULTS There were no differences in the number and largest size of uterine fibroids, total weight of uterine fibroids, console time, and volumes of intravenous fluid administered during RALM among the three groups, whereas combined operation was performed more commonly in group 2 than in groups 1 and 3 (53.9% vs. 0 to 7.7%; p=0.01). The primary and secondary endpoints were also not different among the three groups. However, two patients in group 1 (15.4%) showed vasopressin-related hypertension. CONCLUSION Vasopressin diluted in a volume of 100 ml showed an effective hemostatic effect and safety during RALM (Trial No. NCT04874246 in ClinicalTrial.gov).
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Efficacy and cost-effectiveness of darbepoetin alfa once every 4 weeks versus continuous erythropoietin receptor activator once every 4 weeks for anemia correction in patients with chronic kidney disease not on dialysis
Park, G. N., Lee, K. H., Moon, J. E., Choi, S. J., Park, M. Y., Kim, J. K., Yu, B. C.
Kidney research and clinical practice. 2024
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Editor's Choice
Abstract
BACKGROUND For anemia management in patients with chronic kidney disease not on dialysis, darbepoetin alfa (DA), which has a shorter half-life but is more inexpensive than continuous erythropoietin receptor activator (CERA), is preferred in Korea. This study evaluated the efficacy, safety, and cost-effectiveness of once-in-4-weeks DA compared with once-in-4-weeks CERA in patients with chronic kidney disease not on dialysis. METHODS In this randomized, prospective, non-inferiority study, 40 erythropoiesis-stimulating agent-naïve patients with chronic kidney disease not on dialysis were randomized 1:1 to the DA group and CERA group. They received the study drug once in 4 weeks during 10- or 12-week correction period and 24-week efficacy evaluation period. The primary outcomes were the mean difference in the changes in hemoglobin levels between baseline and efficacy evaluation period and hemoglobin response rates during the correction period. The secondary outcomes included differences in adverse events and costs. RESULTS DA was non-inferior to CERA for anemia correction; the mean difference in the change in hemoglobin levels between the groups was -0.070 g/dL (95% confidence interval, -0.730 to 0.590 g/dL). Hemoglobin response rates were 100% with DA and 94.1% with CERA. Adverse events were comparable. The mean cost of DA was approximately one-third that of CERA (34,100 ± 7,600 Korean won/4 weeks vs. 115,500 ± 23,600 Korean won/4 weeks; p < 0.001). CONCLUSION Once-in-4-weeks DA safely corrects anemia in erythropoiesis-stimulating agent-naïve patients with chronic kidney disease not on dialysis and is more cost-effective than once-in-4-weeks CERA.
PICO Summary
Population
Patients with chronic kidney disease not on dialysis (n= 40).
Intervention
Darbepoetin alfa (DA), (n= 20).
Comparison
Continuous erythropoietin receptor activator (CERA), (n= 20).
Outcome
The patients received the study drug once in 4 weeks during 10- or 12-week correction period and 24-week efficacy evaluation period. The primary outcomes were the mean difference in the changes in haemoglobin levels between baseline and efficacy evaluation period and haemoglobin response rates during the correction period. DA was non-inferior to CERA for anaemia correction; the mean difference in the change in haemoglobin levels between the groups was -0.070 g/dL (95% confidence interval [-0.730, 0.590 g/dL]). Haemoglobin response rates were 100% with DA and 94.1% with CERA. Adverse events were comparable. The mean cost of DA was approximately one-third that of CERA (34,100 ± 7,600 Korean won/4 weeks vs. 115,500 ± 23,600 Korean won/4 weeks).
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Tranexamic acid for the prevention and treatment of postpartum hemorrhage in resource-limited settings: a literature review
Gedeno Gelebo, K., Mulugeta, H., Mossie, A., Geremu, K., Darma, B.
Annals of medicine and surgery (2012). 2024;86(1):353-360
Abstract
INTRODUCTION Postpartum haemorrhage is a major cause of maternal morbidity and mortality worldwide. Early recognition and appropriate treatment are crucial for managing postpartum haemorrhage. OBJECTIVES This literature review aimed to evaluate the efficacy of tranexamic acid in the prevention and treatment of postpartum haemorrhage in resource-limited settings. SEARCH METHODS This literature review was conducted based on the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) guidelines. A computerized systematic search of the MEDLINE (PubMed), Google Scholar, and Cochrane databases using a combination of the following Medical Subject Headings (MeSH) terms for PubMed: [(obstetric haemorrhage OR postpartum haemorrhage OR massive obstetric haemorrhage) AND (tranexamic acid OR antifibrinolytic drugs) AND (prophylaxis OR prevention) AND (management OR treatment) AND (resource-limited settings OR resource-limited area OR developing countries)] to find articles published in English since 2010. SELECTION CRITERIA Studies on the obstetric population who underwent vaginal or caesarean delivery, comparing the use of tranexamic acid versus placebo (or no treatment) for treatment (or prevention) of postpartum haemorrhage with the outcome of postpartum haemorrhage rate, blood transfusion requirements, uterotonics requirements, hysterectomy, or mortality were included. RESULT In total, 5315 articles were identified. Following the elimination of duplicates, the methodological quality of 15 studies was evaluated independently, with eligibility determined based on the inclusion and exclusion criteria, as well as outcome variables. Finally, eight articles were included in the review. CONCLUSION This review provides evidence that the administration of tranexamic acid has the potential to decrease the need for blood transfusion, incidence of postpartum haemorrhage, demand for supplementary uterotonics, and maternal morbidity and mortality with marginal adverse effects. Healthcare systems must develop and implement interventions that involve the use of tranexamic acid for the treatment of postpartum haemorrhage in resource-limited settings.
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The efficacy of platelet rich plasma on women with poor ovarian response: a systematic review and meta-analysis
Wu, L., Su, F., Luo, P., Dong, Q., Ma, M., Ye, G.
Platelets. 2024;35(1):2292612
Abstract
BACKGROUND Platelet-rich plasma (PRP) is a therapeutic approach that is gaining attention for its potential in the treatment of poor ovarian response. This meta-analysis aimed to systematically review and analyze clinical studies to evaluate the impact of PRP on poor responders undergoing ovarian stimulation for IVF. METHODS A comprehensive search was conducted in electronic databases, including PubMed, Embase, Scopus, Web of Science, and the Cochrane Library to identify relevant studies published in English. The pooled data, such as pregnancy outcome, number of MII oocytes, number of transferable embryos, and ovarian reserve markers were analyzed using R version 4.2.3. RESULTS A total of 10 trials were enrolled in the present meta-analysis. Following PRP treatment, live birth rate was found to be 16.6% (95% CI 8.8%-26.1%), while clinical pregnancy rate was observed to be 25.4% (95% CI 13.1%-39.9%). PRP pretreatment resulted in a higher number of MII oocytes (MD 1.073, 95% CI 0.720 to 1.427), a higher number of embryos (MD 0.946, 95% CI 0.569 to 1.323), a higher antral follicle count (MD 1.117; 95% CI 0.689 to 1.544), and the change of hormone levels. CONCLUSIONS Among the studies evaluated in this review, PRP showed promising results in poor responder. Further research is required to clarify the potential role of PRP in female reproductive health. What is the context? The incidence of poor ovarian response following ovarian stimulation ranges globally from 5.6% to 35.1%.Although various interventions have been implemented in patients with POR, there is a lack of empirical evidence demonstrating the superiority of any of these therapies over one another.Platelet-rich plasma, which is rich in growth factors that have been implicated in cellular growth, differentiation, angiogenesis, and tissue repair, is emerging as a promising therapeutic modality.Limited data determines the viability of PRP as an alternative therapy for POR patients, but further evidence is needed to quantify this effect.What is new? To the best of our knowledge, this is the first systematic review and meta-analysis that investigated the efficacy of PRP on women with POR, including ten trials and 876 patients.This review provides a comprehensive overview of the existing evidence on the utilization of PRP in poor responders, while also emphasizing the primary limitations in the literature and the necessity for future research based on evidence.What is the impact? Among the studies evaluated in this review, PRP showed a potential positive impact on the regulation of sex hormone levels, ovarian response, and pregnancy outcomes. eng
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COVID-19 Convalescent Plasma Therapy: Long-term Implications
Yoon, H., Li, Y., Goldfeld, K. S., Cobb, G. F., Sturm-Reganato, C. L., Ostrosky-Zeichner, L., Jayaweera, D. T., Philley, J. V., Desruisseaux, M. S., Keller, M. J., et al
Open forum infectious diseases. 2024;11(1):ofad686
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Abstract
BACKGROUND The long-term effect of coronavirus disease 2019 (COVID-19) acute treatments on postacute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) is unknown. The CONTAIN-Extend study explores the long-term impact of COVID-19 convalescent plasma (CCP) therapy on postacute sequelae of SARS-CoV-2 infection (PASC) symptoms and general health 18 months following hospitalization. METHODS The CONTAIN-Extend study examined 281 participants from the original CONTAIN COVID-19 trial (CONTAIN-RCT, NCT04364737) at 18 months post-hospitalization for acute COVID-19. Symptom surveys, global health assessments, and biospecimen collection were performed from November 2021 to October 2022. Multivariable logistic and linear regression estimated associations between the randomization arms and self-reported symptoms and Patient-Reported Outcomes Measurement Information System (PROMIS) scores and adjusted for covariables, including age, sex, race/ethnicity, disease severity, and CONTAIN enrollment quarter and sites. RESULTS There were no differences in symptoms or PROMIS scores between CCP and placebo (adjusted odds ratio [aOR] of general symptoms, 0.95; 95% CI, 0.54-1.67). However, females (aOR, 3.01; 95% CI, 1.73-5.34), those 45-64 years (aOR, 2.55; 95% CI, 1.14-6.23), and April-June 2020 enrollees (aOR, 2.39; 95% CI, 1.10-5.19) were more likely to report general symptoms and have poorer PROMIS physical health scores than their respective reference groups. Hispanic participants (difference, -3.05; 95% CI, -5.82 to -0.27) and Black participants (-4.48; 95% CI, -7.94 to -1.02) had poorer PROMIS physical health than White participants. CONCLUSIONS CCP demonstrated no lasting effect on PASC symptoms or overall health in comparison to the placebo. This study underscores the significance of demographic factors, including sex, age, and timing of acute infection, in influencing symptom reporting 18 months after acute hypoxic COVID-19 hospitalization.
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The effects of injectable platelet-rich fibrin application on wound healing following gingivectomy and gingivoplasty operations: single-blind, randomized controlled, prospective clinical study
Bahar, ŞÇ, Karakan, N. C., Vurmaz, A.
Clinical oral investigations. 2024;28(1):85
Abstract
OBJECTIVES The aim of this study was to evaluate the effects of wound healing using injectable platelet-rich fibrin (IPRF) after gingivectomy and gingivoplasty. MATERIALS AND METHODS In this clinical study, 46 systemically healthy patients with chronic inflammatory gingival enlargement were randomly treated with gingivectomy-gingivoplasty + I-PRF (n=23) or gingivectomy-gingivoplasty alone (n=23). The primary outcome was to evaluate the effect of I-PRF on wound healing over a 3-week follow-up period. Samples collected from gingival crevicular fluid (GCF) were processed using enzyme-linked immunosorbent assay (ELİSA) to measure VEGF and FGF-10 biomarkers. The surgical areas were stained with Mira-2 tone and evaluated in ImageJ. Wound healing was evaluated with Modified Manchester Scar (MMS) scale and Landry, Turnbull, and Howley (LTH) index. RESULTS VEGF values of the control group at baseline, week 2, and week 3 were significantly higher than the test group. In weeks 2 and 3, FGF-10 values were found to be significantly higher in the control group than the test group. The amount of staining was found to be significantly higher in the control group than in the test group on days 3, 7, and 14. LTH values of the control group were significantly lower than the test group and MMS values were significantly higher than those of the test group. CONCLUSIONS I-PRF applications revealed positive effects on epithelial wound healing after gingivectomy and gingivoplasty operations. CLINICAL RELEVANCE Platelet concentrates such as I-PRF accelerate wound healing and contribute to the patient's comfort and quality of life. I-PRF application may have positive effects on wound healing after gingivectomy and gingivoplasty operations.
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High dose of tranexamic acid infusion in primary total knee arthroplasty: A randomized multicenter clinical trail
Xie, J., Huang, Q., Huang, Z., Wang, F., Liu, J., Tian, H., Huang, W., Pei, F.
Chinese medical journal. 2024
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Intravenous iron versus blood transfusion for postpartum anemia: a systematic review and meta-analysis
Caljé, E., Groom, K. M., Dixon, L., Marriott, J., Foon, R., Oyston, C., Bloomfield, F. H., Jordan, V.
Systematic reviews. 2024;13(1):9
Abstract
BACKGROUND Intravenous iron (IV-iron) is used as an alternative to, or alongside, red blood cell transfusion (RBC-T) to treat more severe postpartum anemia (PPA), although optimal treatment options remain unclear. No previous systematic reviews have examined IV-iron and RBC-T, including patient-reported outcomes and hematological responses. METHODS A systematic review and meta-analysis of randomized trials comparing IV-iron and RBC-T with each other, oral iron, no treatment, and placebo for the treatment of PPA. Key inclusion criteria were PPA (hemoglobin < 12 g/dL) and IV-iron or RBC-T as interventions. Key exclusion criteria were antenatal IV-iron or RBC-T. Fatigue was the primary outcome. Secondary outcomes included hemoglobin and ferritin concentrations, and adverse events. From 27th August 2020 to 26th September 2022, databases, registries, and hand searches identified studies. A fixed-effect meta-analysis was undertaken using RevMan (5.4) software. The quality of the studies and the evidence was assessed using the Cochrane Risk of Bias table, and Grading of Recommendations, Assessment, Development, and Evaluation. This review is registered with the Prospective Register of Systematic Reviews (CRD42020201115). RESULTS Twenty studies and 4196 participants were included: 1834 assigned IV-iron, 1771 assigned oral iron, 330 assigned RBC-T, and 261 assigned non-intervention. Six studies reported the primary outcome of fatigue (1251 participants). Only studies of IV-iron vs. oral iron (15 studies) were available for meta-analysis. Of these, three reported on fatigue using different scales; two were available for meta-analysis. There was a significant reduction in fatigue with IV-iron compared to oral iron (standardized mean difference - 0.40, 95% confidence interval (CI) - 0.62, - 0.18, I(2) = 0%). The direction of effect also favored IV-iron for hemoglobin (mean difference (MD) 0.54 g/dL, 95% confidence interval (CI) 0.47, 0.61, I(2) = 91%), ferritin, (MD 58.07 mcg/L, 95% CI 55.74, 60.41, I(2) = 99%), and total adverse events (risk-ratio 0.63, 95% CI 0.52, 0.77, I(2) = 84%). The overall quality of the evidence was low-moderate. DISCUSSION For all outcomes, the evidence for RBC-T, compared to IV-iron, non-intervention, or dose effects of RBC-T is very limited. Further research is needed to determine whether RBC-T or IV-iron for the treatment of PPA is superior for fatigue and hematological outcomes.
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A systematic review of tourniquet use in paediatric orthopaedic surgery: can we extrapolate from adult guidelines?
Pintar, V., Brookes, C., Trompeter, A., Bridgens, A., Hing, C., Gelfer, Y.
EFORT open reviews. 2024;9(1):80-91
Abstract
PURPOSE Tourniquets are commonly used intraoperatively in orthopaedic surgery to control bleeding and improve visibility in the surgical field. Recent evidence has thrown into question the routine use of tourniquets in the adult population resulting in a British Orthopaedic Association standard for intraoperative use. This systematic review evaluates the evidence on the practice, benefits, and risks of the intraoperative use of tourniquets for trauma and elective orthopaedic surgery in the paediatric population. METHODS A prospectively registered systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (PROSPERO CRD42022359048). A search of MEDLINE, Embase, the Cochrane Library and a Grey literature search was performed from their earliest record to 23 March 2023. Studies reporting tourniquet data in paediatric patients undergoing orthopaedic surgery were included. Data extracted included demographics, involved limb, trauma versus elective use, tourniquet use as primary or secondary measure, and tourniquet parameters and complications. RESULTS Thirty-nine studies were included. Tourniquet practices and information reporting varied considerably. Tourniquets were used uneventfully in the majority of patients with no specific benefits reported. Several physiological and biochemical changes as well as complications including nerve injury, compartment syndrome, skin burns, thrombosis, post-operative limb swelling, and pain were reported. CONCLUSIONS Tourniquets are routinely used in both trauma and elective paediatric orthopaedic surgery with no high-quality research affirming benefits. Severe complications associated with their use are rare but do occur. High-quality studies addressing their benefits, the exact indication in children, and the safest way to use them in this population are necessary.
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Clinical outcome post treatment of anemia in pregnancy with intravenous versus oral iron therapy: a systematic review and meta-analysis
Pandey, A. K., Gautam, D., Tolani, H., Neogi, S. B.
Scientific reports. 2024;14(1):179
Abstract
Oral iron therapy is often the most common way of treating anaemia; however intravenous iron is considered effective due to rapid iron replenishment. We have dearth of evidence on clinical outcomes post treatment of anaemia. We have searched studies published in English in PubMed, Cochrane, Scopus, ProQuest, and Google Scholar. Our study analysed the clinical outcomes amongst neonates and mother and the adverse events post treatment and assessed the mean change in maternal haemoglobin concentration in both the groups. Forest plots for the clinical outcomes are presented. From a total of 370 studies, 34 Randomized and quasi experimental studies comparing clinical outcomes post-treatment of anaemia in pregnancy were included for quantitative evidence synthesis. Pooled results of maternal clinical outcomes using random effect model [OR: 0.79 (95% CI 0.66; 0.95); 10 outcomes; 17 studies] showed statistically significant difference among both the groups [Moderate quality evidence]; however no significant difference [OR: 0.99 (95% CI 0.86; 1.14); 7 outcomes; 8 studies] have been observed for neonatal complications [Low quality evidence]. The study found that pregnant women receiving IV iron were significantly less likely to experience adverse events as compared with those receiving oral iron [OR 0.39; (95% CI 0.26-0.60)]; 34 studies; 13,909 women; [Low quality evidence]. Findings from meta-regression analysis showed that IV iron is more likely to reduce maternal complications by 21% compared to oral iron. Increase in odds of adverse maternal outcomes was observed due to increase in gestational age and publication year but no effect for the type of drug used. IV iron increases Hb more and at a higher pace than oral iron. Intravenous iron is more likely to avert adverse maternal outcomes and adverse reactions. However, there is no conclusive evidence on its effectiveness on individual maternal outcome or neonatal outcome/s. Protocol registered with PROSPERO CRD42022368346).