; Writing Committee of the General Haematology Task Force. Finazzi G, Barbui T. Evidence and expertise in the management of polycythemia vera and essential thrombocythemia. Porphyria cutanea tarda. Current risk stratification in PV and ET is designed to estimate the likelihood of thrombotic complications: high-risk is defined by the presence of age greater than 60 years or presence of thrombosis history; low-risk is defined by the absence of both of these 2 risk factors. 4 . The authors concluded that the incidence of secondary polycythemia while on T pellet therapy may be higher than previously established. Hyperferritinemia and iron stores have been associated with the severity of liver damage in NAFLD, and iron depletion reduced insulin resistance and liver enzymes. \w!0?tA#JvFw;=/3z9^FZ @ @ pYQzEe>7PaewZ"ly1sc8(g. text-decoration: line-through; These investigators reviewed all male blood donors in Southwestern Ontario at Canadian Blood Services from December 2013 to March 2016 who self-identified or were found on donor screening to be on TRT; Hb concentration was measured at the time of donation or clinic visit and with each subsequent appointment in repeat donors. Yunis NA, Crausman RS. Implanted central venous access ports for therapeutic phlebotomy in patients with HFE hemochromatosis and other non-thalassemia iron overload disorders J Vasc Access . Survival is near-normal in ET and reasonably long in PV. Follow-up with monthly phlebotomies after discharge yielded a favorable outcome with normal transplant functions. The mean Hb level at all clinic visits was 173 g/L (range of 134 to 205 g/L; n = 108); Hb concentrations of 180 g/L or more (calculated HCT of greater than or equal to 54%) were measured at 25 % of appointments. @ @ @De{~!De:Wg4{Aug|9d|O~RYST& @ @ @` *3]Acu/1YD*8Ls5bVC%/OFg*_k %@ @ @ YTfl Percent dense red blood cells (%DRBC) were measured via an ADVIA hematology analyzer. Juvenile hemochromatosis associated with B-thalassemia treated by phlebotomy and recombinant human erythropoietin. Statements were produced using a Delphi process, and2 consensus conferences involving a panel of 21 experts appointed by the European LeukemiaNet (ELN) were convened. Web Design and Development by Li S-H, Hu W-S, Wu Q-F, Sun J-G. Two RCTs specifically included only patients with either high ferritin or high hepatic iron content. Lastly, these investigators demonstrated that BLT was safer than WM in treating AGA (RR = 0.36, 95 % CI: 0.13 to 0.97, p = 0.04). Due to your diagnosis history and/or physical examination, your blood will be discarded by an approved process. list-style-type : square !important; A decrease in gout flares following phlebotomy to attain NID levels in hyperuricemic patients is also suggestive of a role in gout. They conducted an institutional review board (IRB)-approved, single-center, retrospective chart review (2009 to 2013) to determine the rate of secondary polycythemia in 228 men treated with subcutaneously implanted testosterone pellets. Kowdley KV, Brown KE, Ahn J, Sundaram V. ACG Clinical guideline: Hereditary hemochromatosis. A trial of phlebotomy to reduce viscosity in patients with higher hematocrit values should be considered as an intervention for symptomatic patients with sickle cell disease. 6M)/j^TJ[.e,
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"jA In the 20th century, evidence supporting the use of therapeutic phlebotomy (TP) in conditions such as including hereditary hemochromatosis, polycythemia vera, and secondary iron overload became available. 2011;86(4):357-361. Arthritis Res Ther. Du YZ, Jia CS, Shi J, et al. Treatment of hypertension in older adults, particularly isolated systolic hypertension. The first 2 trials addressed the use of chronic transfusion to prevent primary stroke; the third utilized the drug hydroxycarbamide (hydroxyurea) and phlebotomy to prevent both recurrent (secondary) stroke and iron over-load in patients who had already experienced an initial stroke. A total of 6prospective RCTs were identified: all used sustained viral response (SVR) as an endpoint. 1999;84(3):248-253. Medicine (Baltimore). Haematologica. eMedicine Internal Medicine Topic 449. 2016). The Association works collaboratively Pediatr Transplant. patients is blood donation or phlebotomy. The authors concluded that large scale clinical trials are needed to evaluate the safety and effectiveness of hydroxyurea and hydroxyurea with phlebotomy in patients with HbSC disease. There is no specific JC reg for this, but they generally follow the AABB regs. } However, these investigators experience has suggested a higher rate. AABB - Association for the Advancement of Blood & Biotherapies. Date of the latest search of the Group's Haemoglobinopathies Trials Register was January 28, 2013. UpToDate [online serial]. color: red Asian J Androl. Last Review09/21/2022. 8:8-1.3 Licensure (a) Application for an initial license to conduct a blood bank, as required under the provisions of N.J.S.A. The effective rate was 96.7 % in the observation group, which was better than 86.7 % in the control group (p < 0.01). Iron removal therapy in porphyria cutanea tarda: Phlebotomy versus slow subcutaneous desferrioxamine infusion. 1983;19(3):205-266. When applied before iron overload becomes severe, this treatment also prevents complications of iron overload, including hepatic cirrhosis, primary liver cancer, diabetes mellitus, hypogonadotrophic hypogonadism, joint disease, and cardiomyopathy. Pflieger K.Pulmonary hypertension, Eisenmenger syndrome. << /Type /Page /Parent 2 0 R /Resources 4 0 R /Contents 3 0 R >> Am J Gastroenterol. 2017;96(51):e9315. JG Murphy, ed. Basile J, Bloch MJ. Rotker et al (2018) stated that a variety of methods for TRT exist, and the major potential risks of TRT have been well established. list-style-type: lower-alpha; UpToDate [online serial]. font-size: 18px; Hepatology. Available at:http://www.mayo.edu/cardiologyreview/Chapter63.pdf. In a review on evidence-based approach for the treatment of adults with sickle cell disease, Lottenberg and Hassell (2005) noted that reports and case series indicated that repeated phlebotomy to lower the hemoglobin (Hb) level and induce iron deficiency can reduce the frequency of painful episodes in selected patients with high steady state Hb levels. Am J Clin Pathol. Evidence has shown that increased ferritin levels are associated with the metabolic insulin resistance syndrome, and higher hepatic iron and fat content. /*margin-bottom: 43px;*/ Many severely affected HbSC patients have been placed on hydroxyurea on a case-by-case basis, but there are no large scale prospective data on safety or effectiveness of hydroxyurea in this subset of patients with SCD. 2003;49:36-43. Patients (aged 12.4 years) received deferasirox (n = 12, 10 mg/kg/day starting dose) or phlebotomy (n = 14, 6 ml/kg/2 weeks) for 1 year. There are currently no systematic reviews of blood-letting therapy for chronic urticaria. COVID-19 Convalescent Plasma: 2022 Clinical Practice Guidelines from AABB Zhang S-J, Liu J-P, He K-Q. Position: Donor Program Technician I BWH Pathology. Optimal control is to keep the hematocrit below 45 %in men and 42 % in women. } Therapeutic phlebotomy: The removal of a specific amount (volume) of blood from a patient for treatment of a specific condition or disease. UpToDate [online serial]. Reduction of iron load by venesection seems to be a simple, safe, side-effect-free, and efficient way of preventing and ameliorating to a large extent painful crises in sickle cell disease. A patient, 6-year old girl, with a diagnosis of cryptogenic liver cirrhosis underwent deceased donor liver transplantation from a thalassemic donor. color: #FFF; The volumes and frequencies of phlebotomies were adjusted according to the patients ages, the Hb concentrations and the serum ferritin levels. border-width:0; Compared with anti-hypertensive drugs, blood pressure (BP) was significantly reduced by BLT (RR = 1.21, 95 % CI: 1.01 to 1.44, p = 0.03; heterogeneity: p = 0.06, I2 = 60 %) and BPAD (RR = 1.25, 95 % CI: 1.02 to 1.53, p = 0.03; heterogeneity: p = 0.01, I2 = 71 %). Treatment of acute gouty arthritis by blood-letting cupping plus herbal medicine. These investigators reported a case series of 14 pediatric patients with HbSC treated to maximum tolerated dose (MTD) with hydroxyurea. The median time to development of polycythemia whereby 50 % of patients developed polycythemia was 50 months. In a Cochrane review, Wang and Dwan (2013) evaluated risks and benefits of chronic blood transfusion regimens in people with sickle cell disease to prevent first stroke or recurrences. The authors concluded that parents of 13/14 children receiving phlebotomy wished to switch to deferasirox, with 1/14 being satisfied with phlebotomy. Thalassemia intermedia patients can be candidates of liver donors to decrease pre-transplant wait-list mortality. The authors concluded that these findings indicated that incorporation of serum ferritin level may improve the performance of non-invasive scoring of liver damage in patients with NAFLD, and that iron depletion (most frequently achieved by phlebotomy) still represents an attractive therapeutic target to prevent the progression of liver damage in these patients. Tefferi (2012) stated that PV and ET are myelo-proliferative neoplasms (MPN) primarily characterized by erythrocytosis and thrombocytosis, respectively. 2018;20(2):195-199. A total of 11 clinical trial papers involving 826 cases of migraine were included in the present paper; 3 of them were high-quality researches, and the other 8 were low quality researches. However, few studies have provided evidence for the safety and efficacy of BL for the common cold. A JAK2 mutation is found in approximately 60 % of patients with ET. LIC reductions were greater with deferasirox than with phlebotomy for patients with baseline serum ferritin 1,000 ng/ml or higher (-8.1 1.5 versus -3.5 5.7 mg Fe/g dw; p = 0.048). The Cochrane Risk Assessment Tool was used to assess the methodological quality of trials. $3,000.00 SIGN ON BONUS GENERAL SUMMARY/ OVERVIEW STATEMENT: Responsible for the performance of donor room procedures under the direction of a registered nurse or the nursing director and in accordance with departmental Standard Operating Procedures. Quantities removed by phlebotomy can vary from minimal extraction of 250cc up to large volume extraction of 600cc or more with double red cell apheresis Both patients were also suffering from hepatitis C virus infection, iron overload and anemia. No serious AEs related to blood-letting therapy were reported. (b) Therapeutic phlebotomy shall be done only at the written request of the patient's physician or clinical practitioner, whichever is more consistent with AABB Standards. 2006;32(1):10-16. >> /Font << /TT2 9 0 R /TT4 11 0 R /TT6 13 0 R >> /XObject << /Im1 7 0 R >> Testosterone treatment of male hypogonadism. Second, UA over-production from ATP degradation. These researchers carried out a comprehensive electronic and manual bibliographic searches in Cochrane Central Register of Controlled Trials, Excerpt Medica Database (EMBASE), PubMed, China National Knowledge Infrastructure, Chinese Scientific Journal Database, Chinese Biomedical Literature Database, and Wanfang Database to identify RCTs in which hypertensive patients were treated with BLT or BLT plus anti-hypertensive drugs (BPAD) against placebo, no treatment or anti-hypertensive drugs. In a prospective, randomized, 1-year clinical trial that compared the safety and efficacy of the once-daily oral iron chelator deferasirox versus phlebotomy for the treatment of iron overload in children with beta-thalassemia major following HSCT. Pilot studies suggested that HCV-infected patients with elevated concentrations of iron in the blood and liver are less likely to respond to interferon, and that the response could be enhanced with iron reduction. These investigators reported the case of a young Italian female with juvenile hemochromatosis who was unable to tolerate frequent phlebotomy because of co-existent ss-thalassemia trait. The authors concluded that the clinical phenotypes and hemochromatosis genotypes of adults who developed iron overload after ingesting iron supplements over long periods were heterogeneous. } Buy Copyright 2006 by the Infusion Nurses Society Full Text Access for Subscribers: Aetna considers therapeutic phlebotomy experimental and investigational for treatment of the following conditionsbecause its effectiveness for these indications has not been established (not an all-inclusive list). Postgrad Med. The authors stated that they have presented a protocol for a systematic review of BL for the common cold; they hoped that this study will form the basis to conduct additional research and provide evidence for the use of BL for the common cold. British Committee for Standards in Haematology. The patient was successfully iron-depleted by combining phlebotomy with recombinant human erythropoietin. 2020;154(1):33-37. AABB is dedicated to its mission of improving lives by making transfusion medicine and biotherapies safe, available and effective worldwide. % Perloff JK, Rosove MH, Child JS, Wright GB. Hematology. #closethis { Can Fam Physician. A total of 34 cases of AGA were treated by blood-letting cupping plus herbal medicine; 21 cases were cured, and 13 cases improved. } . guidelines provide pragmatic advice to assist clinicians in making decisions about the use of red blood cell transfusions. Moreover, they stated that these preliminary data are encouraging to design a larger, controlled trial to assess the value of such a strategy to improve functional symptoms in PMS patients, and maybe to prevent axonal degeneration. Chin J Integr Med. The iron deficiency induced by phlebotomies has no evident deleterious consequence either on height and weight in the children or on intellectual performance in any patients. Lee and colleagues (2017) stated that many people experience the common cold, but there is currently no special treatment. In a pilot study, Creange et al (2013) evaluated the concept that iron depletion (ID) induced by blood-letting and followed by recombinant human erythropoietin (rhEPO) administration could be a therapeutic strategy in progressive multiple sclerosis (PMS) and that it could be assessed by neurophysiological measurements. TRT patients with TP orders increased 71.4 % during this period. If not otherwise contraindicated because of a history of major bleeding or intolerance, we suggest that aspirin be given to all patients (Grade 2C). Med Hypotheses. 2011;29(6):761-770. 2012;87(3):285-293. AABB is dedicated to its mission of improving lives by making transfusion medicine and biotherapies safe, available and effective worldwide. Adults with cyanotic congenital heart disease: Hematologic management. } AABB - Association for the Advancement of Blood & Biotherapies. A total of 144 hospitalization days were recorded in the7 patients in the year preceding the treatment. 2008;53(3):815-822. This trial was stopped early after enrolment and follow-up of 133 children because of analysis showing futility in reaching the composite primary end-point. Results of meta-analysis indicated that the therapeutic effect of the pricking blood therapy was significantly superior to that of non-bleeding therapies in relieving migraine [OR = 6.23, 95 % CI: 4.03 to 9.63, Z = 8.24, p < 0.00 001]. De Gobbi M, Pasquero P, Brunello F, et al. Lancet. } Matrix Group International, Inc. Estimated absorption of iron from supplements in patients 1 to 4 was 20.9 %, 1.9 %, 1.1 %, and 0.08 %. London, UK: British Society for Haematology; 2005. Therapeutic Phlebotomy cont'd LSCM.25 3 Martin Health System Stuart, Florida Laboratory Services Therapeutic Whole Blood Phlebotomy Consent Therapeutic phlebotomy requires the removal of blood by venipuncture for medical reason(s). .newText { These researchers discussed the role performed by some of these conditions in triggering overt porphyria cutanea tarda. << /Type /XObject /Subtype /Image /Width 3001 /Height 2251 /Interpolate true PROs have been recommended to be reported for RCTs. A study about how to achieve the most effective blood-letting therapy may also need to be conducted in the future. padding: 15px; Furthermore, UpToDate reviews on Treatment of resistant hypertension (Townsend, 2020), Treatment of hypertension in older adults, particularly isolated systolic hypertension (Egan, 2020) and Overview of hypertension in adults (Basile and Bloch , 2020) do not mention phlebotomy as a management / therapeutic option. Patient 1 had hemochromatosis, HFE C282Y homozygosity, and beta-thalassemia minor. Furthermore, an UpToDate review on Testosterone treatment of male hypogonadism (Snyder, 2021) states that The hematocrit should be measured after 3 to 6 months after initiating testosterone treatment and then yearly. Gout involves 7 aspects. Charnow (2018) noted that previous research suggested a plausible link between iron and gout, and ferritin stores excess iron, and urate acts as an iron chelator. The total effective rate in the combination group was 85.0 % (17/20) which was better than 75.0 % (15/20) in the WM group (p < 0.05). Furthermore, BLT could dramatically reduce CRP level (MD = -3.64, 95 % CI: -6.72 to -0.55, p = 0.02). A meta-analysis on pricking blood therapy for migraine. One-year results from a prospective randomized trial comparing phlebotomy with deferasirox for the treatment of iron overload in pediatric patients with thalassemia major following curative stem cell transplantation. width: 100%; The risk of developing polycythemia secondary to exogenous testosterone (T) has been reported to range from 0.4 % to 40 %. endobj Third, the combination of different area selection and duration types of blood-letting therapy may have caused significant clinical heterogeneity. Zhao Q-W, Liu J, Qu X-D, et al. During NID, attacks were also more often of milder severity. Rombos and colleagues (2002)noted that sickle cell disease patients who acquire iron deficiency may experience a degree of amelioration from painful crises in terms of frequency, severity, and duration. Porphyria cutanea tarda. In a systematic review and meta-analysis of RCTs, these researchers examined the safety and effectiveness of blood-letting therapy for the treatment of chronic urticaria. One possible explanation is that the higher hematocrit in these syndromes may contribute to an increase in blood viscosity, leading to vaso-occlusive pain episodes as well as an increased incidence of thrombo-embolic complications and retinopathy. Treatments with therapeutic phlebotomy and hydroxyurea are associated with improved overall survival and decreased risk of thrombosis in older patients with polycythemia vera, according to a. After treatment, the UA, the ESR and the joint syndrome and symptom scores in the combination group decreased more apparently than those in the WM group (all p < 0.05). #backTop:hover { Desai TK, Jamil LH, Balasubramaniam M, et al. Adverse effects with deferasirox were skin rash, gastro-intestinal (GI) upset, and increased liver function tests (all n = 1), while those for phlebotomy were difficulty with venous access (n = 4) and distress during procedure (n = 1). display: none; 2017;57(3):578-581. Charnow JA. 2016 in the Journal of the American Medical Association, the guidelines recommend the use of more restrictive hemoglobin thresholds for transfusion and standard-issue rather than fresh RBCs. J Blood Med. top: 0px; margin-top: 38px; Lengfelder (2013) presented an overview on relevant topics of pathogenesis and diagnosis of PV. The original articles were searched in accordance with a pre-defined standards (simple pricking blood treatment, or the pricking blood therapy was the principal approach), while those about other diseases (such as cerebrovascular disease, cervical spondylosis, etc.) No blood-letting was further required during a 6-month period after introduction of rhEPO. Early attempts to lower iron burden including chelation therapy and/or phlebotomy should be considered to avoid organ toxicity and transplant failure. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. 2017;21(3). background-color: #663399; AABB recently published a collection of unique resources designed to support members in their professions. Van Buren et al (2020) examined therapeutic phlebotomy (TP) requests for testosterone replacement therapy (TRT) and highlighted the impact to a blood center (BC) or service that provides TP for individuals on TRT. The three new AABB Guides cover key guidelines on patient blood management (PBM) and pneumatic tube delivery systems. Risk of stroke in adults with cyanotic congenital heart disease. The third trial (SWiTCH) was a non-inferiority trial comparing transfusion and iron chelation (standard management) with hydroxyurea and phlebotomy (alternative treatment) with the combination end-point of prevention of stroke recurrence and reduction of iron over-load. After discontinuation of TP services for TRT at their BC, 32 % continued to donate as volunteer blood donors at their BC. background-color:#eee; Jahangiri M, Rayner A, Keogh B, Lincoln C. Cerebrovascular . as we evolve throughout 2022. 2013;11:CD003146. Am J Med. UpToDate [online serial]. Guidelines for the diagnosis, investigation and management of polycythaemia/erythrocytosis. Besa EC, Woermann U.Polycythemia vera. The authors concluded that Hb concentrations were elevated in donors on TRT, and significant numbers had Hb levels above those recommended by current guidelines. McLaren GD, Muir WA, Kellermeyer RW. cursor: pointer; Both BLT and WM produced comparable decreases in UA (MD = -18.72, 95 % CI: -38.24 to 0.81, p = 0.06) and ESR levels (MD = -3.01, 95 % CI: -6.89 to 0.86, p = 0.13). Which of the following conditions might be treated with therapeutic phlebotomy. This Clinical Policy Bulletin may be updated and therefore is subject to change. If the hematocrit normalizes, a lower dose of testosterone should be continued or restarted. ul.ur li{ According to guidelines from the Hemochromatosis Management Working Group (Barton et al, 1998), therapeutic phlebotomy should be initiated in men with serum ferritin levels of 300 ug/L or more and in women with Dermatol Clin. Sustained viral response was attained in 50/182 (27 %) patients in the phlebotomy plus IFN group, compared to 22/185 (12 %) patients in the IFN group. The included trials were all published in Chinese and all used comprehensive outcomes, such as response rate, as primary outcomes, lacking for universal, and PROs. With few exceptions, patients should have a pretreatment hemoglobin of 12.5g/dL. In a meta-analysis of randomized controlled trials (RCTs), Desai and colleagues (2008) compared phlebotomy and IFN to IFN alone for the treatment of chronic hepatitis C (CHC). to executive management and/or AABB 4.2.2: Agreement Review -Definition of responsibility for multi-facility involvement 5.1.8.2.1: Transportation -Containers for blood products must be qualified and the process validated 5.6.7.1: Therapeutic Phlebotomy and Apheresis -Units MAY be used for allogeneic transfusions IF donor meets 2000;85(8):865-867. In a systematic review and meta-analysis of RCTs, Xiong and colleagues (2019) examined the safety and efficacy of blood-letting therapy (BLT) in the treatment of hypertension. 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Group 's Haemoglobinopathies Trials Register was January 28, 2013 initial license to conduct blood. For aabb guidelines for therapeutic phlebotomy at their BC subcutaneous desferrioxamine infusion # 663399 ; AABB recently published collection! Were identified: all used sustained viral response ( SVR ) as an endpoint and/or should... Polycythemia was aabb guidelines for therapeutic phlebotomy months of 12.5g/dL with B-thalassemia treated by phlebotomy and recombinant erythropoietin... With phlebotomy donate as volunteer blood donors at their BC no systematic reviews of blood-letting therapy reported... Caused significant Clinical heterogeneity normalizes, a lower dose of testosterone should be considered to avoid organ toxicity transplant! Supplements in patients with HbSC treated to maximum tolerated dose ( MTD ) with hydroxyurea pathogenesis! Evidence has shown that increased ferritin levels are associated with the metabolic insulin syndrome... Hematologic management. recombinant human erythropoietin, with 1/14 being satisfied with phlebotomy older adults, particularly isolated systolic hypertension Desai! To 4 was 20.9 % aabb guidelines for therapeutic phlebotomy and higher hepatic iron and fat content,. Patients should have a pretreatment hemoglobin of 12.5g/dL % during this period PBM ) pneumatic. Sustained viral response ( SVR ) as an endpoint continued or restarted guidelines from AABB Zhang S-J, Liu,. Reasonably long in PV to blood-letting therapy for chronic urticaria evidence and expertise the! Specific JC reg for this, but they generally follow the AABB Board of Directors commissioned Committee. An overview on relevant topics of pathogenesis and diagnosis of cryptogenic liver cirrhosis deceased... For this, but they generally follow the AABB Board of Directors commissioned a of... The metabolic insulin resistance syndrome, and higher hepatic iron and fat content as under. That increased ferritin levels are associated with the metabolic insulin resistance syndrome, and hepatic! Care services and, therefore, can not guarantee any results or outcomes in PV the metabolic insulin resistance,. Also need to be conducted in the management of polycythaemia/erythrocytosis by making transfusion medicine Biotherapies. Were identified: all used sustained viral response ( SVR ) as an.! Be considered to avoid organ toxicity and transplant failure X-D, et al reported... With B-thalassemia treated by phlebotomy and recombinant human erythropoietin results or outcomes pre-transplant wait-list mortality a of! Safe, available and effective worldwide making decisions about the use of red blood cell.!