This is an open access article under the terms of the Creat ive Commo ns Attri butio n-NonCo mmercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. AbstractBackground: Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy for pseudomyxoma peritonei (PMP) is associated with excessive bleeding and acquired fibrinogen deficiency. Maintaining plasma fibrinogen may support hemostasis.Objectives: To compare hemostatic efficacy and safety of human fibrinogen concentrate (HFC) vs cryoprecipitate as fibrinogen sources for bleeding patients with acquired fibrinogen deficiency undergoing PMP CRS.Methods: FORMA-05 was an off-label single-center, prospective, randomized, controlled phase 2 study. Patients undergoing PMP surgery with predicted intraoperative blood loss ≥2 L received human fibrinogen concentrate (HFC; 4 g) or cryoprecipitate (two pools of 5 units, containing approximately 4.0-4.6 g fibrinogen), repeated as needed.The primary endpoint was a composite of intraoperative and postoperative efficacy, graded using objective 4-point scales and adjudicated by an independent committee. Results:One hundred percent of patients receiving HFC (95% confidence interval: 83.9-100.0, n = 21) or cryoprecipitate (84.6-100.0, n = 22) achieved hemostatic success. HFC demonstrated noninferior efficacy (P = .0095; post hoc) and arrived in the operating room 46 minutes faster. There were significantly greater mean increases with HFC vs cryoprecipitate in plasma fibrinogen (0.78 vs 0.35 g/L; P < .0001) and FIBTEM A20 (3.33 vs 0.93 mm; P = .003). Factor XIII, factor VIII, and von Willebrand factor activity were maintained throughout surgery. Only red blood cells were transfused intraoperatively (median units: HFC group, 1.0; cryoprecipitate group, 0.5).Thromboembolic events were detected with cryoprecipitate only. Safety was otherwise comparable between groups. | 353ROY et al.
Patients treated with upfront TXA and cryoprecipitate during CRS required less RBC transfusion than those treated with the standard protocol of early FFP.
ObjectivesTo review the current best surgical practice and detail a multi-disciplinary approach that could further reduce joint replacement infection.MethodsReview of relevant literature indexed in PubMed.ResultsSurgical site infection is a major complication following arthroplasty. Despite its rarity in contemporary orthopaedic practice, it remains difficult to treat and is costly in terms of both patient morbidity and long-term health care resources.ConclusionsEmphasis on education of patients and all members of the health-care team and raising awareness in how to participate in preventative efforts is imperative.
Background: Myeloproliferative neoplasms (MPN) including polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF) are clonal hemopathies characterized by burdensome symptom profiles and impaired quality of life. Few studies have evaluated patient-reported outcomes during treatment with non-experimental pharmacological regimens. Aims: The Myeloproliferative Neoplasm Quality of Life (MPN-QOL) Study Group aims to objectively quantify MPN symptom severity, frequency and quality of life at baseline and throughout treatment with non-experimental therapies utilizing the Myeloproliferative Neoplasm Symptom Assessment Form - Total Symptom Score (MPN-SAF TSS; JCO 2012). In this abstract, we provide updated results for the prospective international cohort trial currently in active enrollment: the MPN Experimental Assessment of Symptoms by Utilizing Repetitive Evaluation (MEASURE) trial. Methods: This study aims to recruit 180 international ET, PV, and MF (including primary MF and post-ET or post-PV MF) patients receiving non-experimental medical therapy and/or phlebotomy. Patients complete the MPN-SAF for seven consecutive days at enrollment and repeat the survey for an additional seven consecutive days between 90 days and six months. Patients also complete the European Organisation for Research and Treatment of Cancer (EORTC) and M.D. Anderson Symptom Inventory (MDASI) instruments at enrollment and on the first day of the second assessment. At visits, physicians acquired demographic, laboratory, physical examination, and radiographic data. Descriptive statistics were used to summarize data. Results: Clinical Data The MEASURE trial opened for enrollment in 2012 and remains in recruitment phase with 15 participating international sites. To date, 39 patients have been enrolled and 25 have completed both study visits. Participants include ET (28%), PV (24%), and MF (48%; 50% primary MF, 8% post-ET, 42% post-PV) patients. The majority of patients are male (64%) and of expected age (mean 69.3, range 39-89) for the disorders. Seventeen percent had prior thrombosis, 9% required red blood cell transfusion, and none reported prior splenectomy or hemorrhage. Mean hematologic measures included hemoglobin 13.2 g/dL, WBC count 11.4 x109/L, ANC 8.5 x109/L, and platelets 514 x109/L. Therapies received prior to enrollment included aspirin (n=16), hydroxyurea (n=11), phlebotomy (n=8), warfarin/clopidogrel/anticoagulation (n=8), erythropoietin (n=2), and interferon (n=1). The most common current MPN therapies were hydroxyurea (n=9), aspirin (n=9), interferon (n=4), and phlebotomy (n=2). Symptom Assessment In comparing MPN-SAF TSS mean symptom scores, all symptoms except bony pain improved between the first and second visits, including fatigue, early satiety, abdominal discomfort, inactivity, concentration, night sweats, itching, fever, weight loss, and overall quality of life (Figure1). Total MPN-SAF TSS scores improved from a mean of 32.3 to 25.9. On the EORTC, mean scores for physical, role, emotional, and social functioning improved from the first to the second visit (Figure 2). Cognitive functioning showed a slight decline. Global health status measure improved from 60.2 to 72.9. On the MDASI, symptom severity scores decreased from 3.6 to 2.8 from the first to second visit (Figure 3). Symptom distress measure decreased from 4.1 to 3.0. Discussion: Interim results from the MEASURE trial demonstrate that standard, non-experimental treatment regimens offer improvement in quality of life-related symptoms on multiple patient-reported survey instruments including the MPN-SAF TSS, EORTC QLQ-C30, and MDASI. Updated data including symptom correlations and mutational analysis to be presented at the 2016 ASH conference. Disclosures Ross: Novartis Pharmaceuticals: Honoraria, Research Funding; BMS: Honoraria. Radia:Novartis: Honoraria; Pfizer: Honoraria. McMullin:Novartis: Honoraria, Speakers Bureau. Cargo:Novartis: Honoraria; Celgene: Honoraria, Research Funding. Sekhar:Novartis: Research Funding. Mesa:Gilead: Research Funding; CTI Biopharma: Research Funding; Galena: Consultancy; Ariad: Consultancy; Incyte: Research Funding; Novartis: Consultancy; Celgene: Research Funding; Promedior: Research Funding.
Background:The advent of medical alternatives to splenectomy, particularly the thrombopoietin receptor agonists (TPO‐RA) has seen reduction in its use for ITP. It is now generally reserved in the UK for patients who fail multiple lines of therapy.Aims:We aimed to evaluate practices around splenectomy in the UK and long term response rates using data from the UK ITP registry, a large national database of primary ITP cases set up in 2007.Methods:We analysed all splenectomy cases from the UK ITP registry entered to December 2018. Data was studied on demographics, response rates, relapse rates and influence on response to medical therapies. Statistical analysis was performed using STATA. To identify the influence of medical therapies, we divided patients into treatment time brackets: 1989–1998, 1999–2008 and 2009–2018. The following response criteria were used:Complete response (CR platelets>100 x 109/l),partial response (PR platelets>30 but <100x109/l or doubling from baseline),overall response (OR = PR+CR).Results:Of 3236 registered patients(ITP diagnosis date ranging 1951 – 2018), 321(9.92%)(62%F/38%M) had undergone splenectomy with a total of 4611patient‐years follow‐up(Median 13.2 years, IQR 6.68,23.6). Median age at splenectomy was 40 years(y)(IQR27.0, 55.5).86.2%(268 patients) were <65y old and 13.8%(43 patients) 65y or older.72 patients were excluded from subsequent analysis due to incomplete data(including patients who had splenectomy <1989).Number of patients undergoing splenectomy decreased over time:1989–1998 34.1%;1999–2008 14.8%;2009–2018 4.8%. Median time from ITP diagnosis to splenectomy was 1.46y(IQR 0,20.3) increasing from 1.51y(IQR0,9.23.) in 1989–1998 to 1.69y(IQR0.14,18.5) in 2009–2018. This was associated with an increase in median number of treatment modalities from 2(IQR1,3) in 1989–1998 to 3 (IQR1,7) in 2009–2018 and median number of treatment episodes from 1(IQR1,2) in 1989–1998 to 3 (IQR1,11) in 2009–2018 pre‐splenectomy. The most common treatment modalities pre‐splenectomy were prednisolone(92%),IV immunoglobulin(50%),Azathioprine(27%),Rituximab(21%),Dexamethasone(12%),Mycophenolate(10%) and Romiplostim(10%).CR/PR and OR rates post‐splenectomy were 63.1%/24.3%/87.4% at 1month and 52.2%/15.3%/67.5% at 6months.67.2% of patients who had OR to splenectomy at 1month still had OR at latest follow‐up(median follow‐up 10.5y,IQR4.37,14.4).OR in patients <65y old were 86.8% at 1month and 51.8% at 6months post‐splenectomy.OR in those 65y and older were 73.9% at 1month and 46.2% at 6months post‐splenectomy.Beyond 6 months there is a trend towards reducing response in >65y group, but currently further analysis is limited by missing data.Overall median duration of response(DOR) was 2.5y(IQR0.51,7.01).The median DOR fell over time from 7.35y(1989–1998) to 0.52y(2009–2018).Median DOR was 3.02y in <65y old(IQR0.60,7.70) and 0.76y in 65y or older(IQR0.17,4.2.93).In patients who relapsed post‐splenectomy, median time to treatment was 2.56y(IQR0.09,35.48).59patients(18.4%) had complications post splenectomy.42patients(13.1%) had infections of which 32cases(76.2%) were attributed to splenectomy.53patients(11.2%) had an arterial or venous thrombotic event post‐splenectomy. Of 4deaths(1.25%),1 was listed as being attributed to splenectomy.Summary/Conclusion:Splenectomy rates for ITP in the UK have fallen since 1989, associated with increased medical treatment. There appears to be a trend to reduced response rates and shortened remission duration when this is used later in the treatment pathway.
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