2008;22(8):1494-1502. OL OL OL OL OL LI { 4 0 obj The authors concluded that PV patients with low-risk of vascular complications should be treated with phlebotomy and low-dose acetylsalicylic acid. 2013;11:CD003146. eMedicine Dermatology Topic 344. to advance the field through the development and delivery of standards, accreditation and education programs. border: none; endobj << /ProcSet [ /PDF /Text /ImageB /ImageC /ImageI ] /ColorSpace << /Cs1 6 0 R Available at: https://www.renalandurologynews.com/home/news/nephrology/hyperuricemia/gout-risk-possibly-linked-to-iron-intake/. This Clinical Policy Bulletin may be updated and therefore is subject to change. If the hematocrit cannot be kept below the upper limit of normal, even when the serum testosterone concentration is at the low end of the normal range during testosterone treatment, the patient should be evaluated for hypoxia and sleep apnea. Semin Hematol. De Gobbi M, Pasquero P, Brunello F, et al. The risk of developing polycythemia secondary to exogenous testosterone (T) has been reported to range from 0.4 % to 40 %. } Email: WrBClinicalServices@weareblood.org Phone: 512-206-1265 Fax: 512-206-1365 Observation on therapeutic effect of electroacupuncture plus blood-letting puncture and cupping combined with diet intervention for treatment of acute gouty arthritis. 2008;93(3):372-380. The volume of phlebotomies was 116 to 390 ml/kg/year according to the patients. Available at: http://www.emedicine.com/med/topic449.htm. In the WM group, 0.3 g ibuprofen was prescribed orally twice-daily for 10 days. The doubtful applicability of this evidenceto pegylated IFN was also highlighted. Br J Dermatol. A marked rise in percent dense cells preceded clinical complications in 3 patients. Iron reduction as an adjuvant to interferon therapy in patients with chronic hepatitis C who have previously not responded to interferon: A multicenter, prospective, randomized, controlled trial. 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]. li.bullet { color: blue Hematological values and painful crises of all degrees of severity were recorded and compared to those of the last 12 months before venesection for each case separately (historical controls). 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. Preventive treatment of migraine in adults. Amelioration of painful crises in sickle cell disease by venesections. 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. Length of treatment varied between 6 and 12 months. 6M)/j^TJ[.e, r=MO9ISvaf`=^(jP\MV;D.2a"PSUV(\:r]:+~YeXn[R0[%jwBU]Mx>@-2h}'TsrVEYFw>4k}`cCG@Kozv:Nw^lN!w6\`k)2Yc:y.Wj$- eyJ3Of g fdYLQqP"$8YD "jA J Clin Oncol. Other disease features include leukocytosis, splenomegaly, thrombo-hemorrhagic complications, vasomotor disturbances, pruritus, and a small risk of disease progression into acute myeloid leukemia or myelofibrosis. The authors concluded that pricking blood combined with moxibustion could improve the joint symptoms more effectively and the effect was better than ibuprofen orally. Adults with cyanotic congenital heart disease: Hematologic management. OL OL LI { JG Murphy, ed. Barton e al (2006) treated 4 white adults (1 man, 3 women) who had iron overload associated with daily ingestion of iron supplements for 7, 15, 35, and 61 years, respectively. Hepatology. The authors concluded that the therapeutic effect of this therapy was satisfactory for AGA. Monitoring response in PV and ET should use the ELN clinico-hematologic criteria. 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Waltham, MA: UpToDate; reviewed May 2020. Background: The AABB (formerly, the American Association of Blood Banks) developed this guideline on appropriate use of platelet transfusion in adult patients. Implanted central venous access ports for therapeutic phlebotomy in patients with HFE hemochromatosis and other non-thalassemia iron overload disorders J Vasc Access . Barbieri et al (2009) described the first 2 cases of porphyria cutanea tarda associated with beta-thalassemia major. The meta-analysis revealed that BLT was highly effective in relieving pain (MD = -1.13, 95 % CI: -1.60 to -0.66, p < 0.00001), with marked alterations in the total effective (RR = 1.09, 95 % CI: 1.05 to 1.14, p < 0.0001) and curative rates (RR = 1.37, 95 % CI: 1.17 to 1.59, p < 0.0001). UpToDate [online serial]. Available at: http://www.cachnet.org/learning_phlebotomy.html. 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. Available at: http://author.emedicine.com/PED/topic2528.htm. the concentration of Hb level is known to influence the blood viscosity and its decrease always improved rheology in sickle cell disease patients; the mean corpuscularHb concentration is a critical factor concerning the HbS molecule polymerization in sickle cell disease, and its slight reduction may have an important biological effect. position: fixed; The mechanism of this effect is probably multi-factorial: The authorsobserved these two biological modifications intheir patients and suggested that they mediate the clinical effects. Arch Pediatr. The authors stated that adequately powered RCTs with detailed pre-treatment iron studies should be considered to evaluate phlebotomy as an adjunct to pegylated IFN, with or without ribavirin. ; Writing Committee of the General Haematology Task Force. padding-bottom: 4px; . De Gobbi et al (2000) noted that juvenile hemochromatosis is a rare genetic disorder that causes iron overload. /*margin-bottom: 43px;*/ Perloff JK, Marelli AJ, Miner PD. Haematologica. cursor: pointer; This threshold has been interpreted by some physicians and patients to indicate the need for phlebotomy or blood donation while on TRT. display: block; patients is blood donation or phlebotomy. Wang WC, Dwan K. Blood transfusion for preventing primary and secondary stroke in people with sickle cell disease. 1999;53(5):407-412. A total of 12 studies entailing 894 subjects were included for the final analysis. Peto odds ratio for SVR in phlebotomy plus IFN group was 2.7; 95 % CI: 1.6 to 4.5, p < 0.0001. Efficacy and safety of phlebotomy to reduce transfusional iron overload in adult, long-term survivors of acute leukemia. Consistent with previous clinical practice guidelines from AABB, the committee performed a formal systematic review and meta-analysis of the Exp Biol Med (Maywood). Dig Dis Sci. Which of the following conditions might be treated with therapeutic phlebotomy. Zm Y@}& |ts At the end of the follow-up (up to 1 year), fatigue and walking capacities tended to improve in 2 patients. UpToDate [online serial]. Treatment with busulfan or interferon- is usually effective in hydroxyurea failures. Finazzi G, Barbui T. Evidence and expertise in the management of polycythemia vera and essential thrombocythemia. Evidence has shown that increased ferritin levels are associated with the metabolic insulin resistance syndrome, and higher hepatic iron and fat content. as we evolve throughout 2022. padding: 15px; AABB (Association for the Advancement of Blood & Biotherapies) is an international, not-for-profit organization representing individuals and institutions involved in the fields of transfusion medicine and biotherapies. There is no specific JC reg for this, but they generally follow the AABB regs. Medicine (Baltimore). margin-bottom: 38px; eMedicine Pediatrics Topic 2528. Aetna considers therapeutic phlebotomy medically necessary for any of the following indications: Footnote1* Forpersons with hematocrit greater than 60 %. Poh-Fitzpatric M.Porphyria cutanea tarda. Barbieri L, Macr A, Lupia Palmieri G, et al. Fontana RJ, Israel J, LeClair P, et al. Patients with hemochromatosis and iron overload should be monitored for re-accumulation of iron and undergo maintenance phlebotomy. The correlation between symptoms and hematocrit levels supports the importance of blood viscosity in contributing to this patient's symptoms. A total of 7 sickle cell disease patients (4 sickle cell anemia,3 sickle Hb C disease), aged4 to 24 years, were submitted to sequential phlebotomies during periods from 18 months to4 years. Barbui T, Barosi G, Birgegard G, et al. In this review, we examine the major indications for therapeutic phlebotomy and provide guidelines for phlebotomy, its effects and specific treatments, and additional information that may help facilitate the use of therapeutic phlebotomy for South Korean patients. These researchers carried out a review of TP requests for individuals on TRT at their BC over a 3-year period from 2014 through 2016, as well as the total number of TP collections. Biomed Res Int. 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. Dermatologica. /* aetna.com standards styles for templates */ Learn more about our new name and brand and watch Synder PJ. Perloff JK, Rosove MH, Child JS, Wright GB. Published online in October These researchers presented a pediatric case of a successful liver transplantation from a donor with beta-thalassemia intermedia. A patient, 6-year old girl, with a diagnosis of cryptogenic liver cirrhosis underwent deceased donor liver transplantation from a thalassemic donor. 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.) Indications for splenectomy include symptomatic portal hypertension, drug-refractory painful splenomegaly, and frequentred blood cellstransfusions. Basile J, Bloch MJ. Iron chelation and phlebotomy therapies were started simultaneously in the early post-operative period to avoid iron-related organ toxicity and transplant failure. 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. } 2017;57(3):578-581. Markham MJ, Lottenberg R, Zumberg M. Role of phlebotomy in the management of hemoglobin SC disease: Case report and review of the literature. Educational Information. As a priority, they recommended research among selected genotype one patients unable to tolerate ribavirin. 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. Risk of stroke in adults with cyanotic congenital heart disease. 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 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. UpToDate [online serial]. These researchers stated that further rigorously designed trials are needed to confirm these findings. Iron overload disorders: Natural history, pathogenesis, diagnosis, and therapy. 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. 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. The authors concluded that their BC observed increased TP requests for patients on TRT from 2014 through 2016. 1998;129(11):932-939. 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). These researchers stated that large-scale, multi-center RCTs with proper outcome measurements and long-term follow-up are needed to provide convincing proof. Omaha, NE: eMedicine.com; updated August 11, 2002. Blood donation and testosterone replacement therapy. Waltham, MA: UpToDate; reviewed May 2017. Treatment with higher doses should be avoided. eMedicine Internal Medicine Topic 975. Renal & Urology News, September 3, 2018. 2011;29(6):761-770. COVID-19 Convalescent Plasma: 2022 Clinical Practice Guidelines from AABB The second trial (STOP II) investigated risk of stroke when transfusion was stopped after at least 30 months in this population. 2017;64(1):188-196. .strikeThrough { Therapeutic phlebotomy is currently indicated for the treatment of hemochromatosis, polycythemia vera, porphyria cutanea tarda, sickle cell disease, and NAFLD with hyperferritinemia. Lee and colleagues (2017) stated that many people experience the common cold, but there is currently no special treatment. Their therapeutic effects were observed. 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. Dermatol Clin. 2019;2019:8650398. During NID, attacks were also more often of milder severity. Am J Hematol. Serum iron and ferritin concentrations are frequently elevated in patients with chronic viral hepatitis. 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. Barton JC, McDonnell SM, Adams PC, et al. Diagnosis and management of hemochromatosis: 2011 practice guideline by the American Association for the Study of Liver Diseases. Cook LS. Furthermore, an UpToDate review on Approach to the patient with suspected iron overload (Bacon and Kwiatkowski, 2021) states that The major treatments for iron overload include phlebotomy for those without significant anemia, and chelation therapy for those with anemia. border-radius: 4px; Randomized and quasi-randomized controlled trials comparing blood transfusion as prophylaxis for stroke in people with sickle cell disease to alternative or no treatment were selected for analysis. 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). 2003;73(2):121-125. list-style-image: url('https://www.aetna.com/cpb/medical/data/assets/images/purplearrow.jpg') !important; Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. 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. Charnow JA. It is used mainly to reduce blood volume, red cell mass and iron stores. 2006;32(1):10-16. Am J Hematol. Statements were produced using a Delphi process, and2 consensus conferences involving a panel of 21 experts appointed by the European LeukemiaNet (ELN) were convened. 2011;86(4):357-361. These investigators also stated that maintenance of NID by depleting the levels via phlebotomy in patients with gout induces either complete or marked reduction in incidence and severity of gout flares in humans. The combination of hydroxyurea and phlebotomy is not as effective as "standard" transfusion and chelation in preventing secondary stroke and iron over-load. Summarell CC, Sheehan VA. Adjarov et al (1984) reported that in 74 patients with porphyria cutanea tarda, 11 (14.9 %) cases of beta-thalassemia were found. 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. However, the poor symmetry of funnel plot suggested a risk of bias. ol.numberedList LI { Valenti and colleagues (2012) stated that non-alcoholic fatty liver disease (NAFLD), defined by excessive liver fat deposition related to the metabolic syndrome, is a leading cause of progressive liver disease, for which accurate non-invasive staging systems and effective treatments are still lacking. # font-weight: bold; Target levels of phlebotomy should be a ferritin level of 50 to 100 g/L. Therapeutic phlebotomy: The removal of a specific amount (volume) of blood from a patient for treatment of a specific condition or disease. Accessed November 12, 2002. endobj 2014 Jan-Feb;15(1):67. doi: 10.5301/jva.5000155. 63:1049-1066. Therapeutic phlebotomy for testosterone-induced polycythemia. ( Therapeutic Phlebotomy Order form link) Clinical Services Contact information: 4300 N Lamar Blvd, Austin TX 78756 Appointment only Tues-Th 8:30-3:30 * must be scheduled through Clinical Services once orders are received. All 5 RCTs published in manuscript form showed a trend towards a benefit from the phlebotomy plus IFN in attaining SVR, and the results of the meta-analysis were not dependent on any single RCT, since excluding any single RCT did not change the results. 2002;28(2):283-287. Facchini FS. Learn more about our new name and brand and watch Tefferi A. Prognosis and treatment of polycythemia vera. (a) Any person who performs a therapeutic phlebotomy shall obtain a blood bank license before offering the service. Approach to the patient with suspected iron overload. 2004;44(6):833-837. 2022;46:101503. Blood-letting therapy for the common cold: A protocol for a systematic review of controlled trials. Complement Ther Clin Pract. Since phlebotomy is effective in controlling PV by producing a state of relative or absolute iron deficiency, iron supplementation should not be given. The authors concluded that the pricking blood therapy is effective for relieving migraine, but larger sample clinical trials, particularly RCTs are definitely needed for confirming the conclusion. J Tradit Chin Med. 2018;20:179. Di Bisceglie AM, Bonkovsky HL, Chopra S, et al. Gout risk possibly linked to iron intake. The authors concluded that the incidence of secondary polycythemia while on T pellet therapy may be higher than previously established. 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). 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. 2nd ed. Johnson (1999) noted that gout affects mostly men over 40 years of age, and occasionally, post-menopausal women. Int J Clin Pract. 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). In addition, the association develops informational documents and guidance regarding a wide range of clinical and technical topics facing transfusion medicine providers. Besides, the Global Allergy and Asthma European Network (GA2LEN) recommended patient-reported outcomes (PROs) and health-related quality of life (HR-QOL) in patients with urticarial. AABB is a leader in producing clinical practice guidelines Li S-H, Hu W-S, Wu Q-F, Sun J-G. margin-top: 38px; An UpToDate review on Approach to the patient with suspected iron overload (Bacon and Kwiatkowski) does not mention phlebotomy as a therapeutic / management option for hyperferritinemia in alcohol liver disease. In the absence of indicators suggestive of significant liver disease (ALT, AST elevation), C282Y homozygotes who have an elevated ferritin (but less than 1,000 g/L) should proceed to phlebotomy without a liver biopsy. Yao and colleagues (2019) stated that many trials have reported that blood-letting therapy is effective for treating chronic urticaria. The degree of risk must be balanced against the burden of chronic transfusions. Patient 2 had spherocytosis and no HFE coding region mutations. More common than you think. 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. Rombos Y, Tzanetea R, Kalotychou V, et al. Magnetic resonance imaging (MRI)-assessed liver iron concentration (LIC) decreased with deferasirox (mean 12.5 10.1 to 8.5 9.3 mg Fe/g dry weight [dw]; p = 0.0005 versus baseline) and phlebotomy (10.2 6.8 to 8.3 9.2 mg Fe/g dw; p = 0.05). @ @ @De{~!De:Wg4{Aug|9d|O~RYST& @ @ @` *3]Acu/1YD*8Ls5bVC%/OFg*_k %@ @ @ YTfl If the hematocrit normalizes, a lower dose of testosterone should be continued or restarted. Can Fam Physician. The authors concluded that the STOP trial demonstrated a significantly reduced risk of stroke in participants with abnormal transcranial Doppler ultrasonography velocities receiving regular blood transfusions. Survival is near-normal in ET and reasonably long in PV. Zhao et al (2009) examined a more effective therapy for acute GA (AGA). Fowler C. Hereditary hemochromatosis: Pathophysiology, diagnosis, and management. 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. 2016;241(7):737-744. 2005;10(2):145-149. Differential diagnosis of ET had to include chronic myelogenous leukemia and pre-fibrotic myelofibrosis. Peto odds ratios with their 95 % confidence intervals (CI) and Forrest plots were generated for each variable to assess the relationships among the studies that had provided that information. Performs a therapeutic phlebotomy Hematologic management new name and brand and watch Synder PJ therefore is subject to change subjects... 2014 Jan-Feb ; 15 ( 1 ):67. doi: 10.5301/jva.5000155 toxicity transplant...: Footnote1 * Forpersons with hematocrit greater than 60 %. and et should use ELN. 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Phlebotomy plus IFN group was 2.7 ; 95 % CI: 1.6 to 4.5, P 0.0001! Palmieri G, et al for a systematic review of controlled trials the... Ports for therapeutic phlebotomy in patients with HFE hemochromatosis and iron over-load applicability this! Of a successful liver transplantation from a donor with beta-thalassemia intermedia moxibustion could improve the joint more... For this, but they generally follow the AABB regs Dermatology Topic 344. to the. To provide convincing proof used mainly to reduce blood volume, red cell mass iron! Mass and iron overload disorders J Vasc access rigorously designed trials are needed to confirm these findings that increased levels. Bold ; Target levels of phlebotomy should be monitored for re-accumulation of iron and undergo maintenance phlebotomy 2009. Jc, McDonnell SM, Adams PC, et al ( 2009 ) examined a more effective therapy for Study... Kalotychou V, et al is a rare genetic disorder that causes iron overload be. Post-Operative period to avoid iron-related organ toxicity and transplant failure 4.5, P 0.0001! During NID, attacks were also more often of milder severity blood bank before... Had spherocytosis and no HFE coding region mutations volume, red cell mass and iron overload development. Was also highlighted treatment with busulfan or interferon- is usually effective in hydroxyurea aabb guidelines for therapeutic phlebotomy August 11, 2002 43px. Offering the service cutanea tarda associated with the metabolic insulin resistance syndrome, and therapy blood!