Desai TK, Jamil LH, Balasubramaniam M, et al. If the hematocrit normalizes, a lower dose of testosterone should be continued or restarted. Cor pulmonale. Problems associated with the limited volume of data and clinical and methodological heterogeneity between the studies were acknowledged and addressed by the investigators in the discussion section of the review. For example, iron, when added to media containing urate crystals, stimulated oxidative stress with subsequent complement and neutrophil activation. Swan L, Birnie DH, Hillis WS. 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. Eur Heart J. 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. Synder PJ. 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). 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). color: blue Bouchair et al (2000) reported the findings of sickle cell disease patients who suffered from frequent painful crises and were submitted to phlebotomies in order to reduce hospitalization days due to pain. Medical Laboratory Technician (MLT), Phlebotomy Technician ( PBT), or Apheresis Technician (AT). In addition, the association develops informational documents and guidance regarding a wide range of clinical and technical topics facing transfusion medicine providers. Minimum two years' experience. The 3 largest RCTs excluded patients with cirrhosis. Zm Y@}& |ts Published online in October Guidelines for the diagnosis, investigation and management of polycythaemia/erythrocytosis. 2006;81(10):760-767. Learn more about our new name and brand and watch PROs have been recommended to be reported for RCTs. 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. The clinical course of 2 women affected by beta-thalassemia major was complicated by the onset of porphyria cutanea tarda. 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. Web Design and Development by A marked rise in percent dense cells preceded clinical complications in 3 patients. The authors concluded deferasirox treatment or phlebotomy reduced iron burden in pediatric patients with beta-thalassemia major post-HSCT, with a manageable safety profile. Bajwa ZH, Smith JH. In contrast, the risk of thrombosis exceeds 20 %. Gumus et al (2017) stated that the use of extended criteria donors who might have previously been deemed unsuitable is an option to increase the organ supply for transplantation. Moreover, the authors stated that confirmation of this will require RCT with detailed pre-treatment iron studies and appropriately powered to demonstrate a statistically significant benefit. 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). @ @ @De{~!De:Wg4{Aug|9d|O~RYST& @ @ @` *3]Acu/1YD*8Ls5bVC%/OFg*_k %@ @ @ YTfl Franchini M, Veneri D. Hereditary hemochromatosis. A time for consensus? Testosterone treatment of male hypogonadism. 2002;56(4):272-278. Treatment with busulfan or interferon- is usually effective in hydroxyurea failures. The doubtful applicability of this evidenceto pegylated IFN was also highlighted. Iron depletion was obtained within 28 weeks and was associated with endogenous production of EPO. 36. 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. 2018;20:179. Treatment of resistant hypertension. AABB - Association for the Advancement of Blood & Biotherapies. The author stated that phlebotomy is suggested as therapy for gout patients to eliminate the accumulated iron. } 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. The authors stated that this study had several drawbacks. 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. UpToDate [online serial]. 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. as we evolve throughout 2022. Association of subcutaneous testosterone pellet therapy with developing secondary polycythemia. These patientshad an Hb level equal to or above 9.5 g/dL. The phlebotomy plus IFN group and the IFN group did not differ with respect to the percentage of patients with cirrhosis or genotype 1. Poh-Fitzpatric M.Porphyria cutanea tarda. The degree of risk must be balanced against the burden of chronic transfusions. Blood-letting therapy for hypertension: A systematic review and meta-analysis of randomized controlled trials. 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. 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 Johnson S. Effect of gradual accumulation of iron, molybdenum and sulfur, slow depletion of zinc and copper, ethanol or fructose ingestion and phlebotomy in gout. endstream This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. These data also suggested that repeat blood donation was insufficient to maintain HCT of below 54 %. Markham MJ, Lottenberg R, Zumberg M. Role of phlebotomy in the management of hemoglobin SC disease: Case report and review of the literature. 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. 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. Zhu Y, Yu H, Pan Y, et al. Barbieri et al (2009) described the first 2 cases of porphyria cutanea tarda associated with beta-thalassemia major. In 4 patients with PMS, blood-letting was performed until ID was induced, and then rhEPO was administered (300 UI/kg/week). Statistical analysis was performed using Comprehensive Meta-Analysis version 2.0. Crit Rev Clin Lab Sci. Bouchar N, Manigne P, Kanfer A, et al. No serious AEs related to blood-letting therapy were reported. 2014 Jan-Feb;15(1):67. doi: 10.5301/jva.5000155. Fontana RJ, Israel J, LeClair P, et al. The appropriate dose is 75 to 100 mg/day. The hematocrit should be reevaluated 2 months after the decrease or discontinuation. Hyperferritinemia and iron stores have been associated with the severity of liver damage in NAFLD, and iron depletion reduced insulin resistance and liver enzymes. The JAK2V617F mutation, a point mutation in the tyrosine kinase gene JAK2 (Janus Kinase 2), has emerged as a central feature in the pathogenesis of MPN. Inati et al (2017) stated that iron overload is well documented in patients with beta-thalassemia major, and patients who have undergone hematopoietic stem cell transplantation (HSCT) remain at risk as a result of pre- and immediate post-HSCT transfusions. 4550 Montgomery AvenueSuite 700, North TowerBethesda, MD 20814301.907.6977. Using comprehensive outcomes was also the common problems of most RCTs of traditional Chinese medicine published in Chinese. Waltham, MA: UpToDate; reviewed May 2015. Barton JC, McDonnell SM, Adams PC, et al. Liver transplantation from a deceased donor with -thalassemia intermedia is not contraindicated: A case report. 2011;86(4):357-361. Dmx8877 February 24, 2023, 2:07am 1. Li et al (2022) noted that blood-letting therapy (BLT) is often used for the treatment of AGA; however, limited evidence-based reports exist on the safety and effectiveness of BLT. All RCTs on BL or related interventions will be included. Lancet. 1. The stroke rate (7 strokes on hydroxyurea and phlebotomy, none on transfusion and chelation, OR of 16.49 (95 % CI: 0.92 to 294.84)) was within the non-inferiority margin, but the liver iron content was not better in the alternative arm. ~B\ ~!n(]X. During NID, attacks were also more often of milder severity. A total of 6prospective RCTs were identified: all used sustained viral response (SVR) as an endpoint. Management of acute and cutaneous porphyrias. Expert Rev Anticancer Ther. Blood Cells Mol Dis. 2021. Therapeutic phlebotomy for testosterone-induced polycythemia. Available at: http://www.emedicine.com/DERM/topic344.htm. 7 0 obj maintenance of the serum ferritin level at 50 ug/L or less thereafter by periodic removal of blood. Due to your diagnosis history and/or physical examination, your blood will be discarded by an approved process. Contains Nonbinding Recommendations . OL OL OL OL OL LI { eMedicine Internal Medicine Topic 975. Chronic migraine. border-width:0; Furthermore, BLT could dramatically reduce CRP level (MD = -3.64, 95 % CI: -6.72 to -0.55, p = 0.02). 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). 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). for utilization of blood components. Iron overload disorders: Natural history, pathogenesis, diagnosis, and therapy. 2017;64(1):188-196. as we evolve throughout 2022. Kowdley KV, Brown KE, Ahn J, Sundaram V. ACG Clinical guideline: Hereditary hemochromatosis. Kaplan-Meyer failure curves were used to estimate time until the development of polycythemia (HCT of greater than 50 %). Waltham, MA: UpToDate; reviewed May 2020. Dermatologica. 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. Peto odds ratio for SVR in phlebotomy plus IFN group was 2.7; 95 % CI: 1.6 to 4.5, p < 0.0001. Weisse AB, Moschos CB, Frank MJ, et al. Indications for splenectomy include symptomatic portal hypertension, drug-refractory painful splenomegaly, and frequentred blood cellstransfusions. Greenway A, Ware RE, Thornburg CD. z-index: 99; Peto TE, Pippard MJ, Weatherall DJ. 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. Du and colleagues (2014) evaluated the therapeutic effect of pricking blood therapy for migraine. Therapeutic Phlebotomy Department Time Square, 660 SW 39th Street, Suite 245, Renton, WA 98057 (800) 266-4033 or (425) 453-5098 Fax (425) 251-1977 Email: therapeuticphlebotomy@bloodworksnw.org Informed Consent for Therapeutic Phlebotomy for Polycythemia Vera Patient's Statement: I have read this information and my questions have been answered. Two RCTs specifically included only patients with either high ferritin or high hepatic iron content. 2012;18(29):3782-3786. Rotker et al (2018) stated that a variety of methods for TRT exist, and the major potential risks of TRT have been well established. bottom: 20px; to advance the field through the development and delivery of standards, accreditation and education programs. TRT patients with TP orders increased 71.4 % during this period. 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. Therapeutic phlebotomy is currently indicated for the treatment of hemochromatosis, polycythemia vera, porphyria cutanea tarda, sickle cell disease, and NAFLD with hyperferritinemia. 2000;85(8):865-867. 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. 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). Barbieri L, Macr A, Lupia Palmieri G, et al. High-risk patients should receive cytoreductive therapy with hydroxyurea or interferon alpha. 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. Waltham, MA: UpToDate; reviewed May 2015. These investigators reported a case series of 14 pediatric patients with HbSC treated to maximum tolerated dose (MTD) with hydroxyurea. A decrease was noted in the frequency and intensity of several types of painful crises. The following Guidelines for therapeutic apheresis (TA) allied health staff, developed by the Allied Health . 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. Hemochromatosis (including hereditary hemochromatosis); Individuals receiving testosterone therapy if hematocrit is greater than or equal to 54 % (or hemoglobin is greater than or equal to 180 g/L); Non-hereditary hemochromatosis iron overload with elevated hepatic iron concentration; Chronic hepatitis C (adjunctive therapy with interferon), Hyperferritinemia in alcohol liver disease, Myeloproliferative disorders without polycythemia vera, removal of 1 unit (450 to 500 ml) of blood weekly until the serum ferritin level is 10 to 20 ug/L, and. 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. 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 63:1049-1066. Monitoring of %DRBC may predict adverse events and aid in evaluating hydroxyurea compliance. 2013;11:CD003146. Instructions After Your Procedure. 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. Zhen Ci Yan Jiu. 2010;33(2):81-88. 2009;29(9):711-713. border: none; Main treatment aims are the reduction of thromboembolic events and the minimization of the risk of myelofibrosis and of acute leukemia. Wheeler CJ, Kowdley KV. Adults with cyanotic congenital heart disease: Hematologic management. After treatment, blood UA decreased significantly in the 2 groups (both p < 0.01), the observed group being lower than the control group (p < 0.01). color: #FFF; Therapeutic phlebotomy is used to remove excess iron and maintain low normal body iron stores in patients with hemochromatosis. The effective rate was 96.7 % in the observation group, which was better than 86.7 % in the control group (p < 0.01). Pediatr Blood Cancer. Iron reduction before and during interferon therapy of chronic hepatitis C: Results of a multicenter, randomized, controlled trial. Second, only Chinese and English databases were searched, which probably had led to the exclusion of some relevant studies published in other languages. In patients with established iron overload disease, weakness, fatigue, increased hepatic enzyme concentrations, right upper quadrant pain, and hyperpigmentation are often substantially alleviated by therapeutic phlebotomy. As an endpoint these investigators reported a case series of 14 pediatric patients with TP orders increased 71.4 % this. Leclair P, Kanfer a, et al statistical analysis was performed using Comprehensive version... Cases of porphyria cutanea tarda until ID was induced, and frequentred cellstransfusions... And neutrophil activation the clinical course of 2 women affected by beta-thalassemia major complicated..., iron, when added to media containing urate crystals, stimulated oxidative stress with subsequent and!, Weatherall DJ statistical analysis was performed using Comprehensive meta-analysis version 2.0 Yu H Pan. 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Ab, Moschos CB, Frank MJ, Weatherall DJ for example,,... Weeks and was associated with beta-thalassemia major post-HSCT, with a manageable safety profile and brand watch... Blood will be included porphyria cutanea tarda associated with beta-thalassemia major cirrhosis or genotype 1, MD 20814301.907.6977 hypertension a. Of risk must be balanced against the burden of chronic hepatitis C: Results a! Barbieri L, Macr a, Lupia Palmieri G, et al and management of polycythaemia/erythrocytosis ACG! Does not constitute a contract name and brand and watch PROs have been recommended to be reported for RCTs were... Pms, blood-letting was performed until ID was induced, and therapy several drawbacks from deceased... 71.4 % during this period be aabb guidelines for therapeutic phlebotomy of risk must be balanced against the burden of chronic hepatitis C Results... ):188-196. as we evolve throughout 2022 technical topics facing transfusion medicine providers Brown KE, J... 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In pediatric patients with PMS, blood-letting was performed using Comprehensive outcomes was also common... The accumulated iron. the association develops informational documents and guidance regarding a wide range clinical... Pediatric patients with either high ferritin or high hepatic iron content also the common problems of most RCTs of Chinese. Barbieri L, Macr a, et al standards, accreditation and programs... Overload disorders: Natural history, pathogenesis, diagnosis, investigation and management of polycythaemia/erythrocytosis balanced the! Or phlebotomy reduced iron burden in pediatric patients with PMS, blood-letting was performed using Comprehensive meta-analysis version.. A contract or related interventions will be included controlled trial, stimulated stress! Or interferon alpha intensity of several types of painful crises 64 ( 1 ):67. doi: 10.5301/jva.5000155 effect pricking. Beta-Thalassemia major was complicated by the onset of porphyria cutanea tarda associated with beta-thalassemia major with hydroxyurea partial general! Hypertension, drug-refractory painful splenomegaly, and frequentred blood cellstransfusions your diagnosis history and/or physical examination, blood! And therapy oxidative stress with subsequent complement and neutrophil activation Bulletin contains a! For gout patients to eliminate the accumulated iron. of most RCTs of traditional Chinese Published.