padding-bottom: 4px; Am J Med. 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. OL LI { 2017;64(1):188-196. At the end of the follow-up (up to 1 year), fatigue and walking capacities tended to improve in 2 patients. Aetna considers therapeutic phlebotomy medically necessary for any of the following indications: Hemochromatosis (including hereditary hemochromatosis); or Individuals receiving testosterone therapy if hematocrit is greater than or equal to 54 % (or hemoglobin is greater than or equal to 180 g/L); or Moreover, a significant improvement in Chinese medicine syndrome by BLT (RR = 1.32; 95 % CI: 1.14 to 1.53, p = 0.0002; heterogeneity: p = 0.53, I2 = 0 %) and BPAD (RR = 1.47; 95 % CI: 1.06 to 2.04, p = 0.02; heterogeneity: p = 0.13, I2 = 56 %) was identified. background: url('https://www.aetna.com/cpb/medical/data/assets/images/purplearrow.jpg') no-repeat; Both patients were also suffering from hepatitis C virus infection, iron overload and anemia. Accessed November 12, 2002. 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. Rotker KL, Alavian M, Nelson B, et al. Haematologica. Gumus, Abbasoglu O, Tanyel C, et al. list-style-type: lower-alpha; Blood donation and testosterone replacement therapy. >> 1999;4(105):208-214. These researchers noted that Kowdley et al recently demonstrated in a multi-center study in 628 adult patients with NAFLD from the NAFLD-clinical research network database with central re-evaluation of liver histology and iron staining that the increased serum ferritin level was an independent predictor of liver damage in patients with NAFLD, and was useful to identify NAFLD patients at risk of non-alcoholic steatohepatitis and advanced fibrosis. Chin J Integr Med. Observation on therapeutic effect of electroacupuncture plus blood-letting puncture and cupping combined with diet intervention for treatment of acute gouty arthritis. The investigator cited a study (Facchini, 2003) showing that use of phlebotomy to maintain NID levels in patients with hyperuricemia was associated with a marked decrease in the incidence and severity of gouty attacks. Eur Heart J. Canadian Adult Congenital Heart Network (CACHNET). Weisse AB, Moschos CB, Frank MJ, et al. As a priority, they recommended research among selected genotype one patients unable to tolerate ribavirin. #backTop:hover { Iron removed by phlebotomy was 32.4, 10.4, 15.2, and 4.0 g, respectively. In addition, the association develops informational documents and guidance regarding a wide range of clinical and technical topics facing transfusion medicine providers. 1986;4(2):297-309. AABB is a leader in producing clinical practice guidelines An evidence-based approach to the treatment of adults with sickle cell disease. patients is blood donation or phlebotomy. list-style-image: url('https://www.aetna.com/cpb/medical/data/assets/images/purplearrow.jpg') !important; /ColorSpace 6 0 R /BitsPerComponent 8 /Length 197438 /Filter /FlateDecode The authors stated that phlebotomy appeared to enhance the efficacy of non-pegylated IFN monotherapy for CHC, but more research was required to confirm this. PHLEBOTOMY Journal of Infusion Nursing 29 (1):p S71-S73, January 2006. More common than you think. The presently available treatment options in PV were discussed and recommendations for the clinical management were given. Yunis NA, Crausman RS. padding: 10px; Must have a working knowledge of AABB, FDA . Association of subcutaneous testosterone pellet therapy with developing secondary polycythemia. In the WM group, 0.3 g ibuprofen was prescribed orally twice-daily for 10 days. The authorsinitiated a therapeutic phlebotomy program in order to lower the hematocrit to pre-splenectomy values, as well as to induce iron deficiency. The number of hospitalization days for crises was considered. The 2022 AABB Virtual Meeting will be Nov. 6-7. Medicine (Baltimore). The moxibustion was adopted for 10 days. Therapeutic phlebotomy is used to remove excess iron and maintain low normal body iron stores in patients with hemochromatosis. Hematology. Furthermore, UpToDate reviews on Preventive treatment of migraine in adults (Bajwa and Smith, 2015) and Chronic migraine (Garza and Schwedt, 2015) do not mention phlebotomy as a therapeutic option. Aetna Inc. and its subsidiary companies are not responsible or liable for the content, accuracy, or privacy practices of linked sites, or for products or services described on these sites. The striking decrease of the number of hospitalization days for all the patients suggests a closed relationship between therapy and clinical improvement. Zhao Q-W, Liu J, Qu X-D, et al. UpToDate [online serial]. Matrix Group International, Inc. No blood-letting was further required during a 6-month period after introduction of rhEPO. eMedicine Internal Medicine Topic 449. margin-bottom: 38px; The mean number of pellets administered was 12 (range of 6 to 16). (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. Overview of hypertension in adults. Diagnosis, management, and differentiation from other hepatic porphyrias. 2019;2019:8650398. AABB recently published a collection of unique resources designed to support members in their professions. 2002;28(2):283-287. First, uric acid (UA) over-production from increased purines in the diet. These researchers stated that large-scale, multi-center RCTs with proper outcome measurements and long-term follow-up are needed to provide convincing proof. A total of 6prospective RCTs were identified: all used sustained viral response (SVR) as an endpoint. OL OL OL LI { stream Due to your diagnosis history and/or physical examination, your blood will be discarded by an approved process. Target levels of phlebotomy should be a ferritin level of 50 to 100 g/L. Email: WrBClinicalServices@weareblood.org Phone: 512-206-1265 Fax: 512-206-1365 The authors concluded that the combined ID-rhEPO therapy could authorize a prolonged administration of rhEPO in PMS patients, able to modify cortical excitability of the glutamatergic and gabaergic circuits. 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. Townsend RR. Guidelines for the diagnosis, investigation and management of polycythaemia/erythrocytosis. Methods: These guidelines are based on a systematic review of randomized, clinical trials and observational studies (1900 to September 2014) that reported clinical outcomes on patients receiving prophylactic or therapeutic platelet . Treatment with busulfan or interferon- is usually effective in hydroxyurea failures. Third, UA over-production from increased de-novo synthesis of purines. Patients with polycythemia vera (PV) and essential thrombocythemia (ET) should be defined as high-risk if age is greater than 60 years or there is a history of previous thrombosis. 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. COVID-19 Convalescent Plasma: 2022 Clinical Practice Guidelines from AABB This Clinical Policy Bulletin may be updated and therefore is subject to change. 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. 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. Available at: http://www.emedicine.com/med/topic1864.htm. For this purpose we prefer the use of hydroxyurea rather than an alkylating agent, radioactive 32P, or interferon alpha. 2003;73(2):121-125. 2011;54(1):328-343. AABB, with the valued assistance of its expert member committees, develops a variety of resources to help guide professionals in keeping abreast of clinical issues in transfusion medicine. There was a positive correlation of log(10) serum ferritin and the quantity of iron removed by phlebotomy (p = 0.0371). Rocchi E, Gibertini P, Cassanelli M, et al. The Medline database and Cochrane registry of controlled trials were searched using the key words "phlebotomy" and "treatment of hepatitis C." Reference lists of review articles discussing the interaction between iron and CHC, and prospective RCTs comparing phlebotomy plus IFN therapy to IFN alone were searched to identify additional RCTs that compared phlebotomy plus IFN to IFN alone. Cook LS. Implanted central venous access ports for therapeutic phlebotomy in patients with HFE hemochromatosis and other non-thalassemia iron overload disorders J Vasc Access . } Gout involves 7 aspects. For additional language assistance: Phlebotomy, therapeutic (separate procedure), Collection of venous blood by venipuncture, Injection interferon beta-1b, 0.25 mg (code may be used for Medicare when drug administered under direct supervision of a physician, not for use when drug is self-administered), Injection, interferon alfacon-1, recombinant, 1 mcg, Interferon alfa-2A, recombinant, 3 million units, Interferon alfa-2B, recombinant, 1 million units, Interferon alfa-N3, (human leukocyte derived), 250,000 IU, Injection, interferon beta-1a, 1 mcg for intramuscular use, Injection, pegylated interferon alfa-2a, 180 mcg per ml, Injection, pegylated interferon alfa-2b, 10 mcg per 0.5 ml, Home injectable therapy; interferon, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drug and nursing visits coded separately), per diem, Abnormal level of blood mineral [non-alcoholic fatty liver disease with hyperferritinemia][not covered for hyperferritinemia in alcohol liver disease], Chronic myeloid leukemia, BCR/ABL-positive and negative, Essential (hemorrhagic) throbocythemia [unless with Polycythemia vera], Myelofibrosis [unless with Polycythemia vera], Multiple sclerosis (MS) [progressive multiple sclerosis], Alcoholic liver disease [hyperferritinemia in alcohol liver disease]. Crit Rev Clin Lab Sci. Units drawn as therapeutic phlebotomies shall not be used for allogeneic transfusion unless the individual undergoing the therapeutic phlebotomy meets all allogeneic donor criteria with the exception of donation interval. } Ann Intern Med. Patient 3 had no anemia, a normal HFE genotype, and no coding region mutations in HAMP, FPN1, HJV, or ALAS2; she was heterozygous for the TFR2 coding region mutation V583I (nt 1,747 G-->A, exon 15). However, randomized controlled clinical trials of therapeutic phlebotomy for HCV treatment have not found significant improvements in sustained virologic response with phlebotomy plus interferon (IFN) compared to IFN alone (Fonatana et al, 2000; Di Bisceglie et al, 2000). Wang WC, Dwan K. Blood transfusion for preventing primary and secondary stroke in people with sickle cell disease. A marked rise in percent dense cells preceded clinical complications in 3 patients. GUIDELINES FOR THERAPEUTIC PHLEBOTOMY PERFORMED BY THE CLINICAL SERVICE Policy: Therapeutic phlebotomies are performed on outpatients and inpatients on a Monday-Friday, 0800-1630 basis either in the DeGowin Blood Center Patient Services area or on the inpatient unit. padding-right: 18px; Rheumatology (Oxford). Barbui T, Barosi G, Birgegard G, et al. Guidelines from the American Gastroenterological Association (Dienstagand McHutchison, 2006) on management of hepatitis C concluded that clinical trials have failed to demonstrate the efficacy of phlebotomy in patients with chronic HCV infection, and that phlebotomy cannot currently be recommended as a treatment for HCV infection. } Du and colleagues (2014) evaluated the therapeutic effect of pricking blood therapy for migraine. Basile J, Bloch MJ. 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]. Most patients are candidates for standard phlebotomy. Am J Hematol. 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. } 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. << /ProcSet [ /PDF /Text /ImageB /ImageC /ImageI ] /ColorSpace << /Cs1 6 0 R Screening for clinically significant AvWS is recommended before administrating aspirin in the presence of extreme thrombocytosis. .arrowPurpleSmall, a:hover.arrowPurpleSmall { Risk of stroke in adults with cyanotic congenital heart disease. J Clin Oncol. Conversely, iron removal inhibited these responses as well as urate-crystal-induced foot pad inflammation in rats in-vivo. Current Canadian guidelines recommend regular laboratory monitoring and discontinuing TRT or reducing the dose if the hematocrit exceeds 54% (hemoglobin 180 g/L). Zhang et al (2010) examined the therapeutic effect of blood-letting cupping plus herbal medicine for the treatment of AGA. 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. Yao Q, Zhang X, Mu Y, et al. These investigators stated that therapeutic phlebotomy was feasible and effective, and would prevent complications of iron overload. Background: The AABB (formerly, the American Association of Blood Banks) developed this guideline on appropriate use of platelet transfusion in adult patients. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. UpToDate [online serial]. 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 serum ferritin levels of 200 ug/L or more, regardless of the presence or absence of symptoms. However, few studies have provided evidence for the safety and efficacy of BL for the common cold. } What condition might be treated with therapeutic phlebotomy. AABB is a leader in producing clinical practice guidelines for utilization of blood components. A study about how to achieve the most effective blood-letting therapy may also need to be conducted in the future. The Endocrine Society guidelines suggest stopping therapy if the hematocrit increases to 54 %. Lottenberg R, Hassell KL. 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. High-risk patients with ET should be managed with cytoreduction, using hydroxyurea at any age. Lengfelder E. Diagnosis and therapy of polycythemia vera in the era of JAK2. Blood-letting therapy for the common cold: A protocol for a systematic review of controlled trials. 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). 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). They screen 7 databases from the date of establishment to July 31, 2020, irrespective of the publication source and language. A total of 7 studies with 512 subjects were included; 1 trial showed a significant difference between blood-letting therapy plus medicine and medicine alone in disease activity control (mean difference [MD] 0.67; 95 % CI: 0.03 to 1.31; p = 0.04); 6 trials (372 subjects) showed a significant difference between blood-letting therapy and pharmacological medication in response rate (risk ratio [RR] 1.10; 95 % CI: 0.97 to 1.26; p = 0.15); 2 studies (170 subjects) showed a significant difference between blood-letting therapy plus pharmacological medication and pharmacological medication in response rate (RR 1.34; 95 % CI: 1.10 to 1.63; p =0.003); 2 studies (126 subjects) reported a statistically significant difference between blood-letting therapy and pharmacological medication in recurrence rate. Asian J Androl. 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. Postgrad Med. height:2px; Creange A, Lefaucheur JP, Balleyguier MO, Galacteros F. Iron depletion induced by bloodletting and followed by rhEPO administration as a therapeutic strategy in progressive multiple sclerosis: A pilot, open-label study with neurophysiological measurements. The authors stated that phlebotomy is a convenient method for porphyria cutanea tarda combined with beta-thalassemia. Repeated phlebotomy resulted in a dramatic decrease in symptoms. Serum ferritin and non-transferrin-bound iron also decreased significantly. These investigators will include RCTs assessing BL for the common cold. For patients at high risk for thrombosis (i.e., age of greater than 60, prior thrombosis), we recommend that treatment with phlebotomy be supplemented with the use of a myelosuppressive agent. The authors concluded that on the basis of diet intervention, electro-acupuncture plus blood-letting puncture and cupping was a better therapy for AGA. Fourth, UA over-production from increased DNA breakdown from cell damage. Yao and colleagues (2019) stated that many trials have reported that blood-letting therapy is effective for treating chronic urticaria. 2013;11:CD003146. Perloff JK, Marelli AJ, Miner PD. Preferred: 1 year of Blood Bank experience. Furthermore, BLT could dramatically reduce CRP level (MD = -3.64, 95 % CI: -6.72 to -0.55, p = 0.02). list-style-type: decimal; Consistent with previous clinical practice guidelines from AABB, the committee performed a formal systematic review and meta-analysis of the Omaha, NE: eMedicine.com; updated December 12, 2001. World J Gastroenterol. Barton JC, McDonnell SM, Adams PC, et al. Ann Intern Med. Barbieri L, Macr A, Lupia Palmieri G, et al. Statements were produced using a Delphi process, and2 consensus conferences involving a panel of 21 experts appointed by the European LeukemiaNet (ELN) were convened. 4 0 obj Length of treatment varied between 6 and 12 months. 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). 2017;96(51):e9315. } For example, iron, when added to media containing urate crystals, stimulated oxidative stress with subsequent complement and neutrophil activation. 2005:58-65. The relationship between ferritin and urate levels and risk of gout. 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. Bacon BR, Kwiatkowski JL. If it increases above the upper limit of normal, a cause should be sought, and if none is found, the dose of testosterone should be decreased or stopped. The Cochrane Risk Assessment Tool was used to assess the methodological quality of trials. Am J Gastroenterol. Tefferi A. Polycythemia vera and essential thrombocythemia: 2012 update on diagnosis, risk stratification, and management. 2003;49:36-43. An improvement of the clinical and biochemical picture of porphyria cutanea tarda in both patients was obtained with chloroquine therapy given that their chronic anemia did not permit phlebotomy. Dmx8877 February 24, 2023, 2:07am 1. 4 . 1999;53(5):407-412. top: 0px; guidelines provide pragmatic advice to assist clinicians in making decisions about the use of red blood cell transfusions. Haematologica. Desai TK, Jamil LH, Balasubramaniam M, et al. Optimal control is to keep the hematocrit below 45 %in men and 42 % in women. DvBu$HV2a`nAykOHM+L"U7gNJf"+J Fowler C. Hereditary hemochromatosis: Pathophysiology, diagnosis, and management. 2020;154(1):33-37. A total of 7 RCTs with 637 hypertensive patients from 1989 to 2017 were identified. Gilbert HS. Prevention of sickle cell crises with multiple phlebotomies. Aetna considers therapeutic phlebotomy medically necessary for any of the following indications: Footnote1* Forpersons with hematocrit greater than 60 %. This patient no longer requires narcotic analgesics for pain, has resolution of constitutional symptoms, and has not required further hospitalizations for vaso-occlusive pain crises. 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). De Stefano V, Za T, Rossi E, et al; GIMEMA CMD-Working Party. The clinical course of 2 women affected by beta-thalassemia major was complicated by the onset of porphyria cutanea tarda. Near-iron deficiency-induced remission of gouty arthritis. Approach to the patient with suspected iron overload. Zhu et al (2015) compared the differences in clinical effectiveness between pricking blood combined with moxibustion and Western medication (WM) for the treatment of AGA. Presence of extreme thrombocytosis (platelet count greater than 1,000 10(9)/L) might be associated with acquired von Willebrand syndrome (AvWS) and, therefore, risk of bleeding. Mean corpuscular volume, mean corpuscular Hb concentration and serum ferritin were also reduced. Hereditary hemochromatosis: A review of the genetics, mechanism, diagnosis, and treatment of iron overload. Second, UA over-production from ATP degradation. Diagnosis and management of hemochromatosis: 2011 practice guideline by the American Association for the Study of Liver Diseases. High-risk patients with PV should be managed with phlebotomy, low-dose aspirin, and cytoreduction, with either hydroxyurea or interferon at any age. Toronto, ON: CACHNET; 2002. Accessed November 12, 2002. State of Florida- Medical Technologist License in at least one specialty: Immunohematology. The haematological management of patients with cyanotic congenital heart disease. OL OL LI { Bouchar N, Manigne P, Kanfer A, et al. These findings raised concerns regarding the persistent risk of vascular events in these donors, especially when coupled with the misperception by patients and health care providers that donation has reduced or eliminated the risks of TRT-induced polycythemia. An UpToDate review on Prognosis and treatment of polycythemia vera (Tefferi, 2013) states that In subjects without active thrombosis and those not at risk for thrombosis (i.e., age of less than 60, no prior thrombosis), we recommend that the hematocrit be kept within the normal range via the use of serial phlebotomy, rather than by the use of myelosuppressive agents (Grade 1A). Prefer the use of hydroxyurea rather than an alkylating agent, radioactive 32P, or interferon any. X, Mu Y, et al complications of iron overload, Qu X-D, et al Nursing (., Nelson B, et al ( 2010 ) examined the therapeutic effect of pricking therapy... Combined with diet intervention, electro-acupuncture plus blood-letting puncture and cupping was a better for... A therapeutic phlebotomy medically necessary for any of the follow-up ( up to 1 ). Than 60 % ; Must have a working knowledge of aabb, FDA quality of trials to July,. Diagnosis and therapy of polycythemia vera in the diet KL, Alavian M, Nelson B, et.. 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