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1.
Treatment of Atrophic Acne Scars: Topical or intralesional plasma gel?
Moustafa Mohamed M, Sabry HH, Salem RM
Photodermatology, photoimmunology & photomedicine. 2021
Abstract
BACKGROUND Atrophic post acne scarring is considered to be a therapeutic challenge. OBJECTIVES The aim was to compare the safety and efficacy of A) FCL combined with intradermal injection of plasma gel, B) FCL combined with topical application of plasma gel, and C) FCL monotherapy in the treatment of atrophic postacne scars. METHODS Thirty patients with facial atrophic post-acne scars were enrolled in this study and randomly assigned into one of three groups. All of them underwent 4 treatment sessions at 4-weeks intervals. They were assessed objectively by the quantitative global scarring grading system (GSGS). This system was applied at baseline, and after 1- and 6-month follow-up (FU). Subjective assessments were performed through the global aesthetic improvement scale (GAIS) and level of patient satisfaction. The DLQI questionnaire was employed at the baseline and 6-month FU. RESULTS According to the quantitative GSGS scores, the reductions in group A (68.4%) and group B (63%) scores were comparable and both were significantly higher than that in group C (41.2%) in all steps of evaluation. At 6-month FU, both groups A and B showed further significant improvement while group C did not. Based on the GAIS and patients' satisfaction, there were no significant differences between all groups. The reductions in DLQI scores in groups A and B were comparable, however both were significantly higher than group C (p<0.001). CONCLUSIONS The combination of plasma gel and FCL resurfacing was noticeably outstanding in their efficacy and impact on the patients' quality of life.
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2.
Plasma trial: Pilot randomized clinical trial to determine safety and efficacy of plasma transfusions
Carson JL, Ness PM, Pagano MB, Philipp CS, Bracey AWJr, Brooks MM, Nosher JL, Hogshire L, Noveck H, Triulzi DJ
Transfusion. 2021
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Editor's Choice
Abstract
BACKGROUND Plasma is frequently administered to patients with prolonged INR prior to invasive procedures. However, there is limited evidence evaluating efficacy and safety. STUDY DESIGN AND METHODS We performed a pilot trial in hospitalized patients with INR between 1.5 and 2.5 undergoing procedures conducted outside the operating room. We excluded patients undergoing procedures proximal to the central nervous system, platelet counts <40,000/μl, or congenital or acquired coagulation disorders unresponsive to plasma. We randomly allocated patients stratified by hospital and history of cirrhosis to receive plasma transfusion (10-15 cc/kg) or no transfusion. The primary outcome was change in hemoglobin concentration within 2 days of procedure. RESULTS We enrolled 57 patients, mean age 56.0, 34 (59.6%) with cirrhosis, and mean INR 1.92 (SD = 0.27). In the intention to treat analysis, there were 10 of 27 (38.5%) participants in the plasma arm with a post procedure INR <1.5 and one of 30 (3.6%) in the no treatment arm (p < .01). The mean INR after receiving plasma transfusion was -0.24 (SD 0.26) lower than baseline. The change from pre-procedure hemoglobin level to lowest level within 2 days was -0.6 (SD = 1.0) in the plasma transfusion arm and -0.4 (SD = 0.6) in the no transfusion arm (p = .29). Adverse outcomes were uncommon. DISCUSSION We found no differences in change in hemoglobin concentration in those treated with plasma compared to no treatment. The change in INR was small and corrected to less than 1.5 in minority of patients. Large trials are required to establish if plasma is safe and efficacious.
PICO Summary
Population
Patients with cirrhosis (n= 57).
Intervention
Plasma transfusion (n= 27).
Comparison
No transfusion (n= 30).
Outcome
In the intention to treat analysis, there were 10 of 27 (38.5%) participants in the plasma arm with a post procedure INR <1.5 and one of 30 (3.6%) in the no treatment arm. The mean INR after receiving plasma transfusion was -0.24 (SD 0.26) lower than baseline. The change from pre-procedure haemoglobin level to lowest level within 2 days was -0.6 (SD = 1.0) in the plasma transfusion arm and -0.4 (SD = 0.6) in the no transfusion arm. Adverse outcomes were uncommon.
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3.
Investigating the Effect of Fresh Frozen Plasma and Albumin on DNA Damage and Oxidative Stress Biomarkers in Poisoning Cases by Organophosphates
Afzali S, Karami M, Kheyripour N, Ranjbar A
Drug research. 2020
Abstract
The efficacy of albumin and fresh frozen plasma (FFP) and their effects on biomarkers of oxidative stress has been evaluated. In a randomized clinical control trial, 33 poisoned patients by Organophosphate (OP) were enrolled in the research and divided into three groups. The first group underwent conventional treatments by atropine and pralidoxime (control group); the second and third groups, in addition to traditional treatments, received albumin and FFP. Cholinesterase (ChE) enzyme activity, total antioxidant capacity (TAC), serum thiol groups (TTG), malonyl aldehyde (MDA) and DNA damage were measured in all treatment and control groups. Patients were matched in terms of demographic characteristics at the beginning of the study. ChE activity was increased in all three groups during treatment, which was more noticeable in the FFP group and was statistically significant in both albumin and FFP group compared to the control group (p<0.05). TAC increased, and TTG decreased in FFP and albumin groups compared to the control group; no significant difference was observed. MDA decreased in albumin and FFP and was significantly different in the FFP group compared to the control group (p<0.05). The amount of DNA damage in FFP and albumin groups decreased, and there was a significant difference compared to the control group (p<0.05). According to the results of this study, due to the decrease of oxidative damage parameters and the increase of antioxidant parameters in albumin and specially FFP groups, FFP may be considered as an adjunctive treatment for OP poisoning.
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Efficacy and safety of plasma gel as a new modality in treatment of atrophic acne scars
Elfar NN, Hasby EA
International journal of dermatology. 2020
Abstract
BACKGROUND Postacne scarring is an unfortunate and frequent complication of acne, with varied morphological forms and associated significant psychological distress to patients. AIM OF THE WORK To evaluate the efficacy and safety of plasma gel injection alone and in combination with microneedling in treatment of atrophic postacne scars. PATIENTS AND METHODS Sixty patients with atrophic postacne scars were enrolled in this single blinded randomized controlled study. The patients were divided into three groups with 20 patients being treated with intradermal injection of plasma gel, 20 patients treated with dermaroller, and 20 patients subjected to combined plasma gel and dermaroller. Patients received four sessions at monthly intervals and were evaluated by clinical, histopathological, and immunohistochemical analysis. RESULTS There was statistically significant improvement in postacne scars after treatment in all studied groups with variable degrees; the combined technique showed the best clinical improvement in postacne scars. There was an increase in newly formed collagen and elastic fibers with more organized and condensed bundles after the end of treatment. CONCLUSION Plasma gel showed a remarkable improvement for most patients after one session, providing a quick and easy solution for acne scars. The combination of dermaroller and plasma gel potentiated its effect with more improvement in scars.
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5.
Anti-influenza immune plasma for the treatment of patients with severe influenza A: a randomised, double-blind, phase 3 trial
Beigel JH, Aga E, Elie-Turenne MC, Cho J, Tebas P, Clark CL, Metcalf JP, Ozment C, Raviprakash K, Beeler J, et al
The Lancet. Respiratory medicine. 2019
Abstract
BACKGROUND Infection with influenza virus causes substantial morbidity and mortality globally, although antiviral treatments are available. Previous studies have suggested that anti-influenza immune plasma could be beneficial as treatment, but they were not designed as randomised, blinded, placebo-controlled trials. Therefore, we aimed to prospectively evaluate the clinical efficacy of high-titre immune plasma compared with standard low-titre plasma to improve outcomes in patients with severe influenza A infection. METHODS We did this randomised, double-blind, phase 3 trial at 41 US medical centres to assess the efficacy of high-titre anti-influenza plasma (haemagglutination inhibition antibody titre ≥1:80) compared with low-titre plasma (≤1:10). Children and adults with PCR-confirmed influenza A infection, a National Early Warning score of 3 or greater, and onset of illness within 6 days before randomisation were eligible. Patients were randomly assigned (2:1) using an interactive web response system to receive either two units (or paediatric equivalent) of high-titre plasma (high-titre group) or low-titre plasma (low-titre group), and were followed up for 28 days from randomisation. High-titre and low-titre plasma had the same appearance. Randomisation was stratified by severity (in intensive care unit, not in intensive care but requiring supplemental oxygen, or not in intensive care and not requiring supplemental oxygen) and age (<18 years and ≥18 years). All participants, site staff, and the study team were masked to treatment allocation until after the final database lock. The primary endpoint was clinical status assessed by a six-point ordinal scale on day 7 (death, in intensive care, hospitalised but requiring supplemental oxygen, hospitalised not requiring supplemental oxygen, discharged but unable to resume normal activities, and discharged with full resumption of normal activities) analysed in a proportional odds model (an odds ratio [OR] >1 indicates improvement in clinical status across all categories for the high-titre vs the low-titre group). The primary analysis was done in the intention-to-treat population, excluding two participants who did not receive plasma. This trial is registered with ClinicalTrials.gov, NCT02572817. FINDINGS Participants were recruited between Jan 26, 2016, and April 19, 2018. Of 200 participants enrolled (177 adults and 23 children), 140 met the criteria for randomisation and were assigned to the high-titre group (n=92) or to the control low-titre group (n=48). One participant from each group did not receive plasma. At baseline, 60 (43%) of 138 participants were in intensive care and 55 (71%) of 78 participants who were not in intensive care required oxygen. 93% of planned plasma infusions were completed. The study was terminated in July, 2018, when independent efficacy analysis showed low conditional power to detect an effect of high-titre plasma even if full accrual (150 participants) was achieved. The proportional OR for improved clinical status on day 7 was 1.22 (95% CI 0.65-2.29, p=0.54). 47 (34%) of 138 participants experienced 88 serious adverse events: 32 (35%) with 60 events in the high-titre group and 15 (32%) with 28 events in the low-titre group. The most common serious adverse events were acute respiratory distress syndrome (ARDS; four [4%] vs two [4%]), allergic transfusion reactions (two [2%] vs two [4%]), and respiratory distress (three [3%] vs none). 65 (47%) participants experienced 183 adverse events: 42 (46%) with 126 events in the high-titre group and 23 (49%) with 57 events in the low-titre group. The most common adverse events were anaemia (four [3%] vs two [4%]) and ARDS (four [3%] vs three [5%]). Ten patients died during the study (six [7%] in the high-titre group vs four [9%] in the low-titre group, p=0.73). The most common cause of death was worsening of acute respiratory distress syndrome (two [2%] vs two [4%] patients). INTERPRETATION High-titre anti-influenza plasma conferred no significant benefit over non-immune plasma. Although our study did not have the precision to rule out a small, clinically relevant effect, the benefit is insufficient to justify the use of immune plasma for treating patients with severe influenza A. FUNDING National Institute of Allergy and Infectious Diseases of the National Institutes of Health (Bethesda, MD, USA).
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6.
Safety, Tolerability, and Feasibility of Young Plasma Infusion in the Plasma for Alzheimer Symptom Amelioration Study: A Randomized Clinical Trial
Sha SJ, Deutsch GK, Tian L, Richardson K, Coburn M, Gaudioso JL, Marcal T, Solomon E, Boumis A, Bet A, et al
Jama Neurology. 2018
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Abstract
Importance: Young mouse plasma restores memory in aged mice, but, to our knowledge, the effects are unknown in patients with Alzheimer disease (AD). Objective: To assess the safety, tolerability, and feasibility of infusions of young fresh frozen plasma (yFFP) from donors age 18 to 30 years in patients with AD. Design, Setting, and Participants: The Plasma for Alzheimer Symptom Amelioration (PLASMA) study randomized 9 patients under a double-blind crossover protocol to receive 4 once-weekly infusions of either 1 unit (approximately 250 mL) of yFFP from male donors or 250 mL of saline, followed by a 6-week washout and crossover to 4 once-weekly infusions of an alternate treatment. Patients and informants were masked to treatment and subjective measurements. After an open-label amendment, 9 patients received 4 weekly yFFP infusions only and their subjective measurements were unmasked. Patients were enrolled solely at Stanford University, a tertiary academic medical center, from September 2014 to December 2016, when enrollment reached its target. Eighteen consecutive patients with probable mild to moderate AD dementia, a Mini-Mental State Examination (score of 12 to 24 inclusive), and an age of 50 to 90 years were enrolled. Thirty-one patients were screened and 13 were excluded: 11 failed the inclusion criteria and 2 declined to participate. Interventions: One unit of yFFP from male donors/placebo infused once weekly for 4 weeks. Main Outcome and Measures: The primary outcomes were the safety, tolerability, and feasibility of 4 weekly yFFP infusions. Safety end point analyses included all patients who received the study drug/placebo. Results: There was no difference in the age (mean [SD], 74.17 [7.96] years), sex (12 women [67%]), or baseline Mini-Mental State Examination score (mean [SD], 19.39 [3.24]) between the crossover (n = 9) and open-label groups (n = 9). There were no related serious adverse events. One patient discontinued participation because of urticaria and another because of an unrelated stroke. There was no statistically significant difference between the plasma (17 [94.4%]) and placebo (9 [100.0%]) cohorts for other adverse events, which were mild to moderate in severity. The most common adverse events in the plasma group included hypertension (3 [16.7%]), dizziness (2 [11.1%]), sinus bradycardia (3 [16.7%]), headache (3 [16.7%]), and sinus tachycardia (3 [16.7%]). The mean visit adherence (n = 18) was 86% (interquartile range, 87%-100%) and adherence, accounting for a reduction in the total visit requirement due to early patient discontinuation, was 96% (interquartile range, 89%-100%). Conclusions and Relevance: The yFFP treatment was safe, well tolerated, and feasible. The study's limitations were the small sample size, short duration, and change in study design. The results warrant further exploration in larger, double-blinded placebo-controlled clinical trials. Trial Registration: ClinicalTrials.gov Identifier: NCT02256306.
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7.
Endoscopic treatment for high-risk bleeding peptic ulcers: a randomized, controlled trial of epinephrine alone with epinephrine plus fresh frozen plasma
Khodadoostan M, Karami-Horestani M, Shavakhi A, Sebghatollahi V
Journal of Research in Medical Sciences.. 2016;21:135.
Abstract
BACKGROUND Acute upper gastrointestinal bleeding is a common and potentially life-threatening emergency with substantial mortality. Fresh frozen plasma (FFP), a good source of coagulation factors, might be an ideal injection agent based on its physiologic properties. Therefore, we evaluated the role of FFP as a hemostatic agent in patients with high-risk bleeding peptic ulcers. MATERIALS AND METHODS From August 2015 to April 2016, 108 consecutive patients with high-risk bleeding ulcers were admitted to our university hospital. They were randomly assigned to undergo injection of epinephrine alone (A) or epinephrine plus FFP (B). The primary outcomes assessed were the initial hemostasis, recurrent bleeding, hospital stay, blood transfusion, surgery rate, and 14-day mortality. RESULTS Initial hemostasis was achieved in 47 of 50 patients (94%) in the Group A and 49 of 50 patients (98%) in the Group B (P = 0.61). There were no significant differences in the rate of recurrent bleeding between Group A (14%) and Group B (8%) (P = 0.52). We found no significant differences between Group A and Group B with respect to the surgery rate, bleeding death, procedure-related death, and duration of hospitalization (P > 0.05). CONCLUSION It is concluded the injection of epinephrine alone was equally effective as injection of epinephrine plus FFP to endoscopic hemostasis. Epinephrine alone and epinephrine plus FFP were not different in recurrent bleeding, rate of surgery, blood transfusion, or mortality.
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8.
A randomized study of autologous conditioned plasma and steroid injections in the treatment of lateral epicondylitis
Lebiedzinski R, Synder M, Buchcic P, Polguj M, Grzegorzewski A, Sibinski M
International Orthopaedics. 2015;39((11)):2199-203.
Abstract
PURPOSE Chronic tendinopathy of lateral epicondyle of the humerus, commonly known as "tennis elbow" is one of the most frequent tendinopathies caused by recurrent overload of the muscle origins. The aim of the study was to assess the effectiveness of treating lateral epicondylitis (LE) with autologous conditioned plasma (ACP) and betamethasone injections, and to compare these methods over the course of a one year follow-up. METHODS Patients were randomly placed into one of into two groups: 53 were treated with ACP, and 46 with 1 ml betamethasone injections and 2 ml of 1 % lignocaine. Both those groups were comparable in terms of initial DASH score. RESULTS After six weeks and six months, the mean DASH score was significantly better in the betamethasone group, but was better in ACP group after one year. Full recovery (patients with no symptoms) at all time points was more common in the betamethasone group. A comparison of grouped DASH scores revealed more very good and good results in the ACP group after one year. More patients had pain symptoms related to injection in the ACP group than the betamethasone group. CONCLUSIONS ACP therapy of LE allows better results to be obtained at 12 months. Betamethasone injections give more rapid improvement, but the therapeutic effect is longer lasting in the ACP group.
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9.
Randomized placebo-controlled human pilot study of cold atmospheric argon plasma on skin graft donor sites
Heinlin J, Zimmermann JL, Zeman F, Bunk W, Isbary G, Landthaler M, Maisch T, Monetti R, Morfill G, Shimizu T, et al
Wound Repair & Regeneration. 2013;21((6):):800-7.
Abstract
Cold atmospheric plasma has already been shown to decrease the bacterial load in chronic wounds. However, until now it is not yet known if plasma treatment can also improve wound healing. We aimed to assess the impact of cold atmospheric argon plasma on the process of donor site healing. Forty patients with skin graft donor sites on the upper leg were enrolled in our study. The wound sites were divided into two equally sized areas that were randomly assigned to receive either plasma treatment or placebo (argon gas) for 2 minutes. Donor site healing was evaluated independently by two blinded dermatologists, who compared the wound areas with regard to reepithelialization, blood crusts, fibrin layers, and wound surroundings. From the second treatment day onwards, donor site wound areas treated with plasma (n=34) showed significantly improved healing compared with placebo-treated areas (day 1, p=0.25; day 2, p=0.011; day 3, p<0.001; day 4, p<0.001; day 5, p=0.004; day 6, p=0.008; day 7, p=0.031). Positive effects were observed in terms of improved reepithelialization and fewer fibrin layers and blood crusts, whereas wound surroundings were always normal, independent of the type of treatment. Wound infection did not occur in any of the patients, and no relevant side effects were observed. Both types of treatment were well tolerated. The mechanisms contributing to these clinically observed effects should be further investigated. 2013 by the Wound Healing Society.
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10.
Effectiveness of fresh frozen plasma as supplementary treatment in organophosphate poisoning
Pazooki S, Solhi H, Vishteh HR, Shadnia S, Beigi MJ
The Medical Journal of Malaysia. 2011;66((4):):342-5.
Abstract
With the establishment of the inadequate efficiency of atropines and oximes in reducing morbidity and mortality of patients poisoned by organophosphates, more attention is given to using other methods such as Fresh Frozen Plasma (FFP) as a bioscavenger to mop up organophosphate toxins. This randomized clinical trial was conducted on 56 organophosphate poisoned patients who were randomly assigned to the FFP and control groups in order of admission. The routine treatment in both groups included atropine and, in moderate to severe cases of poisoning, pralidoxime. The FFP group received four packs of FFP as stat dose at the beginning of treatment. No significant difference was seen between the two groups on the atropine and pralidoxime dosage, hospitalization length and mortality. The present study showed that using four packs of FFP as stat dose at the onset of treatment had no significant effect on the clinical course of organophosphate poisoned patients.