Safety Of Plasma Exchange Research Articles

Role of Plasma Exchange and Combining Therapies in Dengue-Associated Acute Liver Failure: A Systematic Review of Individual Cases

Dengue-associated acute liver failure (ALF) poses a significant risk for mortality, especially in regions lacking access to liver transplantation. Although Plasma Exchange (PLEX) is recognized as a potential therapeutic intervention for dengue-associated ALF, data on its efficacy remain limited. This systematic review aimed to comprehensively examine the literature on PLEX and other combination therapies for dengue-associated ALF. It focused on assessing their effectiveness, safety profile, and potential implications for therapeutic interventions. In this study, we conducted a systematic review to assess the efficacy and safety of PLEX and other combination therapies in patients with dengue-associated ALF. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria were used to search the PubMed, Scopus, Embase, Ovid, and Google Scholar databases. Studies published in English between 2019 and May 2024 were included. The titles and abstracts were reviewed for discrepancies, and any differences were resolved through discussion. Among the 713 studies assessed for review, 9 met the eligibility criteria. Studies have demonstrated that PLEX, both alone and in combination with other therapies, such as continuous renal replacement therapy (CRRT), improves liver function, survival rates, and neurological outcomes in patients with dengue virus. Both high- and low-volume plasma exchanges were effective. This systematic review highlights the beneficial role of PLEX and the potential benefits of combination therapies in the treatment of rare and severe forms of dengue-associated ALF. However, given the limited sample sizes and the necessity for well-designed studies, further investigations are needed to determine the optimal volume of PLEX and the efficacy of additional therapeutic strategies.

The Effect of Plasma Exchange on Recovery of Patients with Coronavirus Disease 2019 (COVID-19) Admitted to the Intensive Care Unit

Introduction: To evaluate the efficacy and safety of Plasma Exchange (PE) in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive pneumonia patients. Method: This study was a case series conducted at a referral hospital. Twenty SARS-CoV-2-positive patients had an oxygen saturation of 80-90%, and the respiratory rate above 30 per minute. These symptoms started 1 week after the onset of the disease. All patients had less than 90% oxygen saturation and needed respiratory support (oxygen therapy) treated with plasma exchange on 3-5 consecutive days during hospitalization. We followed the amount of oxygen saturation, which was in the form of increasing the patient's oxygen saturation above 90% without oxygen supply and above 92% without oxygen, improving shortness of breath and improving patients' clinical symptoms. Results: Our study included a total of 20 COVID-19 patients with an overall mean age of 48.9 ± 12.1 years (range: 39–58 years); 60% (n=12) were males, 34.5% of whom benefited from TPE sessions. On the third day after the treatment, shortness of breath improved in these patients. Oxygen saturation of any twenty patients increased before the procedure of plasma exchange. Clinical symptoms of all patients were decreasing shortness of breath and improving patients' clinical symptoms after the procedure. Conclusion: According to our observations, plasma exchange could not show a significant therapeutic effect in COVID-19 patients with severe lung involvement.

Plasma Exchange versus Intravenous Immunoglobulin in Worsening Myasthenia Gravis: A Systematic Review and Meta-Analysis with Special Attention to Faster Relapse Control.

Currently used rescue interventions to prevent rapid myasthenic deterioration are plasma exchange (PLEX) and intravenous immunoglobulin (IVIG). We investigated the evidence to determine whether the two methods were interchangeable or whether one was superior to the other. This review was registered on PROSPERO (CRD42021285985). Only randomized controlled trials (RCTs) comparing the efficacy and safety of PLEX and IVIG in patients with moderate-to-severe myasthenia gravis (MG) were included. Five major databases were systematically searched (PubMed, CENTRAL, Embase, Scopus, and Web of Science). Odds ratios (OR) with 95% confidence intervals (CI) were calculated for adverse events and mean differences (MD) for changes in quantitative myasthenia gravis scores (QMG). Three RCTs met the inclusion criteria. Two investigating 114 patients in total were eligible for meta-analysis to analyze efficacy and safety. For the change in QMG score, the MD was -2.8 (95% CI: -5.614-0.113), with PLEX performing better. For adverse events, an OR of 1.04 was found (95% CI: 0.25-4.27). This study demonstrated a low risk of bias in evaluating treatment efficacy but indicated a high risk of bias in assessing procedural safety outcomes. Although the results did not show any significant difference, there was a tendency indicating faster efficacy of PLEX in the first two weeks of treatment. In such a critical clinical condition, this tendency may be clinically meaningful, but further studies should clarify this benefit.

Retracted: The Efficacy and Safety of Plasma Exchange in the Treatment of Thrombotic Thrombocytopenic Purpura.

[This retracts the article DOI: 10.1155/2022/3519937.].

Benefit of plasma exchange with albumin replacement on individual items of the quality of life‐Alzheimer’s disease score

AbstractBackgroundAlzheimer Management By Albumin Replacement (AMBAR) is a multicenter, randomized, placebo‐controlled, Phase IIb/III clinical trial that evaluated the efficacy and safety of Plasma Exchange with Albumin replacement (PE‐A) in patients with mild‐to‐moderate Alzheimer’s disease (Boada et al., Alzheimers Dement. 2020). PE‐A has demonstrated an overall benefit in quality of life as measured by the Quality of Life‐Alzheimer’s disease (QoL‐AD) score (Boada et al., Alzheimers Dement. 2021). We evaluated PE‐A treatment benefit for each of 13 individual patient‐rated QoL‐AD items.MethodA cumulative logistic mixed model was applied on the Full Analysis Set (FAS) population. The odds that a patient receiving PE‐A would have a more favorable response (i.e., higher item score) than a similar subject receiving placebo was estimated at final visit for each QoL‐AD item. Age, baseline MMSE score, and baseline individual QoL‐AD item responses were included as covariates.ResultThe FAS included 76 placebo patients and 229 PE‐A‐treated patients. A significant PE‐A treatment effect vs. placebo at final visit was observed for QoL‐AD item 4: Living situation (“How do you feel about the place you live now?“) [Odds Ratio (OR) = 3.92 (95% CI: 1.38‐11.12), p = 0.010] and for QoL‐AD item 13: Life as a whole (“When you think about your life as a whole, everything together, how do you feel about your life?”) [OR = 3.80 (95% CI: 1.32‐10.91), p = 0.013].ConclusionThe analysis demonstrated that when compared to patients on placebo, patients receiving PE‐A were more likely to have a favorable response for the QoL‐AD items “Living situation” and “Life as a whole”, suggesting that the reported benefit of PE‐A vs. placebo on the full QoL‐AD score is also observed in these individual QoL‐AD items.

Efficacy and Safety of Plasma Exchange as an Adjunctive Therapy for Rapidly Progressive IgA Nephropathy and Henoch-Schönlein Purpura Nephritis: A Systematic Review.

Patients with IgA nephropathy (IgAN), including Henoch-Schönlein purpura nephritis (HSP), who present with rapidly progressive glomerulonephritis (RPGN) have a poor prognosis despite aggressive immunosuppressive therapy. The utility of plasmapheresis/plasma exchange (PLEX) for IgAN/HSP is not well established. This systematic review aims to assess the efficacy of PLEX for IgAN and HSP patients with RPGN. A literature search was conducted using MEDLINE, EMBASE, and through Cochrane Database from inception through September 2022. Studies that reported outcomes of PLEX in IgAN or HSP patients with RPGN were enrolled. The protocol for this systematic review is registered with PROSPERO (no. CRD42022356411). The researchers systematically reviewed 38 articles (29 case reports and 9 case series articles) with a total of 102 RPGN patients (64 (62.8%) had IgAN and 38 (37.2%) had HSP). The mean age was 25 years and 69% were males. There was no specific PLEX regimen utilized in these studies, but most patients received at least 3 PLEX sessions that were titrated based on the patient's response/kidney recovery. The number of PLEX sessions ranged from 3 to 18, and patients additionally received steroids and immunosuppressive treatment (61.6% of patients received cyclophosphamide). Follow-up time ranged from 1 to 120 months, with the majority being followed for at least 2 months after PLEX. Among IgAN patients treated with PLEX, 42.1% (n = 27/64) achieved remission; 20.3% (n = 13/64) achieved complete remission (CR) and 18.7% (n = 12/64) partial remission (PR). 60.9% (n = 39/64) progressed to end-stage kidney disease (ESKD). Among HSP patients treated with PLEX, 76.3% (n = 29/38) achieved remission; of these, 68.4% (n = 26/38) achieved CR and 7.8% achieved (n = 3/38) PR. 23.6% (n = 9/38) progressed to ESKD. Among kidney transplant patients, 20% (n = 1/5) achieved remission and 80% (n = 4/5) progressed to ESKD. Adjunctive plasmapheresis/plasma exchange with immunosuppressive therapy showed benefits in some HSP patients with RPGN and possible benefits in IgAN patients with RPGN. Future prospective, multi-center, randomized clinical studies are needed to corroborate this systematic review's findings.

Plasma exchange and COVID 19

Plasma exchange and COVID 19

Feasibility, safety, and tolerability of two modalities of plasma exchange with albumin replacement to treat elderly patients with Alzheimer's disease in the AMBAR study.

In the Alzheimer Management by Albumin Replacement (AMBAR) study, mild-to-moderate Alzheimer's disease (AD) patients were treated with a plasma exchange (PE) program. Feasibility and safety of PE in this specific population are poorly understood and were analyzed in detail in this study. Qualified patients were treated with 6 weeks of weekly conventional therapeutic plasma exchange (TPE) with albumin replacement followed by monthly low-volume plasma exchange (LVPE) for 12 months. The patients were divided into four groups: placebo (sham PE treatment), low-albumin (20 g), low-albumin + intravenous immunoglobulin (IVIG) (10 g), and high-albumin (40 g) + IVIG (20 g). Adverse events (AEs) were recorded and analyzed for all PE treatment groups and PE modalities. PE procedure-related AEs were more common in the active treatment groups (16.9% out of 1283 TPE and 12.5% out of 2203 LVPE were associated with at least one AE, a similar rate than in other PE indications) than in the placebo group (0.7% out of 1223 sham PE). Percentage of procedures with at least one AEs was higher with central venous access compared to peripheral venous access in all three active treatment groups (20.1% vs 13.1%, respectively). The TPE and LVPE procedures used in the AMBAR study on mild-to-moderate AD population were as safe and feasible as in other therapeutic applications of PE or routine plasmapheresis.

The Efficacy and Safety of Plasma Exchange in the Treatment of Thrombotic Thrombocytopenic Purpura.

Background Thrombotic thrombocytopenic purpura (TTP) is a clinically rare thrombotic cardiovascular and microvascular disease. The purpose of this study was to observe the clinical efficacy and safety of plasma exchange in the treatment of TTP. Methods A total of 16 TTP patients who underwent plasma exchange from January 2015 to December 2020 were selected. The clinical data of all patients were collected for retrospective analysis. The effective rate of treatment, the changes of blood cell count before and after treatment, and adverse reactions during treatment were analyzed. Results A total of 50 plasma exchanges were performed in 16 TTP patients. After plasma exchange treatment, there were 4 invalid and 12 improved patients. The total effective rate of plasma exchange in patients with TTP was 75.0%. After treatment, platelet count (PLT) and hemoglobin (Hb) levels were significantly increased in TTP patients. Compared with before treatment, lactate dehydrogenase (LDH), indirect bilirubin (IBIL), total bilirubin (TBIL), and broken red blood cells were significantly reduced. In addition, 3 adverse reactions occurred in 50 plasmapheresis procedures, and the incidence of adverse reactions was 6.0%. Conclusion Plasma exchange therapy has a good therapeutic effect on TTP and can significantly improve abnormal blood cell count in patients with high safety.

P57 Mapping Quality of Life - Alzheimer's Disease (QOL-AD) Scores to EQ-5D-5L Utilities in the Ambar Trial Population

Health state utilities are required to model the cost/benefit of novel treatments in accordance with Health Technology Assessment guidelines. The AMBAR phase 2b/3 trial (NCT01561053) evaluated the efficacy and safety of plasma exchange with albumin replacement in mild-to-moderate Alzheimer’s disease (AD) patients. Health-related quality of life was measured through the disease-specific Quality of Life - Alzheimer’s disease (QoL-AD) questionnaire. EQ-5D-5L utilities were estimated from AMBAR QoL-AD data using a validated mapping algorithm developed by Rombach et al.

Efficacy and Safety of Plasma Exchange with Albumin Replacement as a Therapy for Amyotrophic Lateral Sclerosis

Background: Neuroinflammation is being increasingly recognized as a key factor in the pathogenesis of amyotrophic lateral sclerosis (ALS). A therapeutic approach for ALS using plasma exchange with albumin replacement (PE-A) has been proposed to remove antibody complexes, inflammatory mediators, and toxins to decrease neuronal damage caused by inflammation. Methods: In this pilot study, 15 patients underwent 24 weeks of PE-A with 5% albumin and their revised ALS Functional Rating Scale (ALSFRS-R) scores and Forced Vital Capacity (FVC) were tracked for 48 weeks to evaluate the efficacy of PE-A as a therapy for ALS. Results: There was a statistically significant decline of ALSFRS-R scores as well as FVC (%) throughout the study. A post hoc comparison with clinically matched control patients showed no statistically significant difference. Likewise, no significant differences were found when the rate of ALSFRS-R decline in the PE-A-treated patients was compared to the European Medicines Agency (EMA) guideline estimate of a −1 point/month decrease in untreated patients. However, 50% of the PE-A-treated patients showed a slow rate of decline of < −0.8 points/month. PE was safe and well tolerated in ALS patients. Conclusion: In conclusion, results of this study indicated that PE-A performed in this manner was safe but showed a considerable heterogeneity in the response to treatment when it comes to slowing the ALS deterioration, with no overall clinical benefit. Further investigation focused on the characterization of ALS patients suitable for PE-A therapy is warranted. Registration: ClinicalTrials.gov ID: NCT02872142.

Efficacy and safety of plasma exchange or immunoadsorption for the treatment of option neuritis in demyelinating diseases: A systematic review and meta-analysis.

There are no systematic reviews yet that evaluated the effects of PE/IA in patients with optic neuritis (ON) in demyelinating diseases. A meta-analysis of available study is needed to further explore the value of plasma exchange (PE) or immunoadsorption (IA) in treating ON in demyelinating diseases. All relevant articles published on PubMed, Web of Science, Cochrane Library, Embase, China National Knowledge Infrastructure (CNKI), VIP Database, Wanfang, Sinomed and ophthalmology professional websites were searched. Study characteristics, demographic characteristics, clinical features and outcome measures were extracted. Response rate, adverse events (AE) rate, serious adverse event (SAE) rate, the log of the minimum angle of resolution (logMAR), visual outcome scale (VOS) and expanded disability status scales (EDSS) were evaluated using a random-effects model. 35 studies were included between 1985 and 2020, containing 1191 patients. The response rates of PE and IA in acute attack of ON were 68% and 82% respectively. LogMAR (-0.60 to - 1.42) and VOS (-1.10 to -1.82) had been significantly improved from within 1 month to more than 1 month after PE treatment. Besides, we found that logMAR improved 1.78, 0.95 and 0.38, respectively ,when the time from symptom onset to the first PE/IA was less than 21 days, 21-28 days, and more than 28 days. The pooled mean difference of EDSS was -1.14.Adverse effects rate in patients with PE or IA were 0.20 and 0.06, respectively. The meta-analysis provided evidence that PE/IA treatment was an effective and safe intervention, and it is recommended that early initiation of PE/IA treatment is critical.

Efficacy and safety of plasma exchange in interstitial lung diseases with anti-melanoma differentiation-associated 5 gene antibody positive clinically amyopathic dermatomyositis

Objective Clinically amyopathic dermatomyositis (CADM) patients frequently develop refractory interstitial lung disease (ILD), with a poor prognosis. We aimed to verify the efficacy and safety of plasma exchange (PE) treatment for ILD in CADM. Method A retrospective case–control study was conducted to compare clinical outcomes with and without PE treatment in CADM-ILD patients refractory to combination therapy of high-dose glucocorticoids, calcineurin inhibitors, and cyclophosphamide. Among 19 enrolled patients, 11 were further treated with PE. We compared survival rates and other clinical characteristics. PE consisted of either fresh-frozen plasma or albumin as a replacement solution. Results Basal clinical characteristics at diagnosis, including age, gender, serum ferritin, Krebs von den Lungen-6 (KL-6), C-reactive protein, and respiratory function tests, did not differ between the two groups. The survival rate for treatment with PE was higher than for treatment without PE (91% and 50%, respectively, p < 0.05). Among PE-treated patients, anti-melanoma differentiation-associated gene-5 (anti-MDA-5) antibody titre, ferritin, and KL-6 as serological activity markers were sustainably reduced only after initiating PE. Therapeutic intervention with PE reduced the frequency of exacerbation of ILD requiring methylprednisolone pulse therapy. The occurrence of bacterial, fungal, and cytomegalovirus infection did not differ between the groups with and without PE, and adverse events associated with PE resolved with appropriate intervention. Conclusion Combination therapy with PE was associated with an improved survival rate, and may be effective for the management of refractory ILD in CADM patients. A personalized therapeutic strategy including PE could be introduced for fatal rapidly progressive ILD.

Efficiency and safety of plasma exchange in the treatment of severe COVID-19

<h3>ЦЕЛЬ ИССЛЕДОВАНИЯ</h3> Изучение эффективности и безопасности применения терапевтического плазмообмена в лечении COVID-19. <h3>МАТЕРИАЛ И МЕТОДЫ</h3> В связи с отсутствием этиотропной терапии коронавирусной инфекции на первый план выходит патогенетическое лечение. Результаты аутопсий, клинических наблюдений и лабораторных данных свидетельствуют о том, что высокие уровни цитокинов и прокоагулянтное состояние могут спровоцировать острый респираторный дистресс-синдром и синдром полиорганной дисфункции с высоким риском смерти. С точки зрения патогенеза метод плазмафереза заслуживает рассмотрения при лечении тяжелобольных пациентов с COVID-19 и является направлением для проведения клинических испытаний. В случае эффективности плазмафереза, возможно, удастся снизить летальность, а также уменьшить длительность стационарного лечения.

Feasibility &amp; Safety of Plasma Exchange in Pediatric Neuro-immunology: A Single Center Experience (1587)

Feasibility &amp; Safety of Plasma Exchange in Pediatric Neuro-immunology: A Single Center Experience (1587)

Feasibility &amp; safety of plasma exchange in paediatric neuro-immunology: A single center experience

There is limited data available on the safety of therapeutic plasma exchange (TPE) for paediatric neuro-immunological disorders (PNID). In this study, we report our data on safety and feasibility of TPE for these disorders. Retrospective chart review was performed to include all patient who received TPE for four major PNID conditions: autoimmune encephalitis (AIE), acute disseminated encephalomyelitis (ADEM), Neuromyelitis optic spectrum disorder (NMOSD) and transverse myelitis (TM). We recorded minor and major adverse effects (AEs) associated with each TPE procedure. Secondary analysis also looked at the efficacy data of TPE on these patients. Thirty-two patients with PNID received a total of 186 TPE cycles. Out of these, only 1 cycle (0.89%) in AIE subgroup, 1 (4.3%) in NMOSD and 1 (4.5%) in TM had adverse effects. No patients had major side effects. TPE was safe and well tolerated in our PNID patients.

Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.

Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.

Efficacy and safety of plasma exchange using a double viral inactivated and prion reduced solvent/detergent fresh frozen plasma for the treatment of thrombotic microangiopathy: The first French experience in a single center

BackgroundOctaplas LG® is the first plasma with marketing authorisation, available in France only since February 2016. This is a double viral inactivated and prion reduced solvent/detergent fresh frozen plasma. Clinical data on Octaplas LG® use in thrombotic microangiopathy (TMA) remains very limited. In May 2017, we were the first hospital in France to benefit of this new plasma product now dispensed by hospital pharmacies. We present a prospective review of all therapeutic plasma exchange (TPE) procedures for TMA patients in our hospital to evaluate the new delivery circuit, the efficacy and the adverse events (AE) related to this plasma. Study design and methodsWe prospectively reviewed 166 TPE procedures where Octaplas LG® was used as replacement fluid in 15 consecutive TMA patients required TPE in our hospital from May 2017 until December 2018. ResultsThe total replacement plasma volume administered was 763 L (3818 units) with a median on 32 L (range 6–157) per episode. Remission was achieved in all cases after a median of 7 TPE per patient’s episode. No exacerbation nor relapse were noted. One patient presented a grade 1 citrate reaction, and another patient an allergic reaction. We deplored pulmonary embolism in 2 patients. ConclusionIn our experience OctaplasLG® was well-tolerated and was effective at inducing a full clinical remission. Although two PE were noted, the relationship to OctaplasLG® in unclear. The new dispensing circuit through the hospital pharmacy has proven to be safe and efficient.

Utility and safety of plasma exchange in paediatric neuroimmune disorders

Our aim was to ascertain the indications, side effects, and outcomes in children receiving therapeutic plasma exchange (TPE) for neurological disorders. Medical records were retrospectively reviewed for 58 consecutive children (age ≤16y) undergoing 67 courses of TPE across four tertiary centres. Patient characteristics, treatment schedules, complications, and outcomes were analysed. Median age at initiation of TPE was 9years (range 1-15y). Indications included peripheral nervous system (PNS; n=18) and central nervous system (CNS; n=40) disorders. Courses comprised a median six exchanges (range 2-179) over 8days (range 3-466). Forty-two out of 58 (73%) children were severely disabled (bedridden) at initiation and 24 out of 58 (41%) were admitted to intensive care units. Treating clinicians' impression of response was positive in 16 out of 18 of those with PNS disorders versus 22 out of 40 with CNS disorders (p=0.016). Improvements in disability (modified Rankin Scale) occurred in 13 out of 58 (22%) children by completion of TPE (p=0.003). Complications occurred in 40 out of 67 (60%) courses, of which 16 out of 67 (24%) were line related. Potentially life-threatening complications occurred in 2 out of 67 (3%) courses. This cohort study provides safety and efficacy information for clinicians and families and a basis for future prospective studies. Disability scores for severe neuroimmune disorders remained stable or improved during therapeutic plasma exchange treatment. Complications occurred frequently but were typically mild and correctable.

Plasma exchange combined with double plasma absorption therapy improve the prognosis of acute-on-chronic liver failure

Objective: To compare the efficacy and safety of plasma exchange (PE) combined with double plasma absorption and simple PE in the treatment of acute-on-chronic liver failure. Methods: We retrospectively analyzed 251 cases of acute-on-chronic liver failure treated with artificial liver treatment since January 2015. Changes in clinical manifestations, laboratory tests, and complications of the patients before and after different modes of treatment were compared and short-term efficacy was tracked. In accordance with different data, t-test, Pearson's chi-squared test and Fisher's exact test were used for statistical analysis. Results: The effectiveness of low-volume PE combined with double plasma molecular adsorption system (DPMAS) and equal amount of PE combined with DPMAS was significantly better than simple PE (83.7%, 84.05% and 82.15 vs 55.6%, P < 0.05) in early stage of liver failure. In late-stage of liver failure, there was no significant difference in the treatment efficiency of each group (P > 0.05). Bilirubin and bile acid levels were significantly decreased in combined treatment groups than that to simple PE group (P < 0.05). PTA and albumin improvement rate of DPMAS PE groups were significantly lower than that of simple PE group (P < 0.05). There was no statistical difference in adverse reactions between each group. Conclusion: PE combined with DPMAS improves the treatment efficiency of early hepatic failure and decrease dosage of plasma when compared with simple PE. A beforehand DPMAS treatment after PE treatment can improve the adverse effects of DPMAS on blood coagulation function and albumin levels.