Therapeutic Phlebotomy

Overview

Therapeutic phlebotomy is a medical procedure involving the controlled removal of blood to treat conditions characterized by excess red blood cells, iron overload, or other hematologic abnormalities. This guideline establishes standards and evidence-based recommendations for safe and effective therapeutic phlebotomy practice.

Core Standards

Standard 1: Vascular Access Device Selection

Selection of the most appropriate vascular access device for therapeutic phlebotomy should occur through shared decision-making involving the patient, caregiver when applicable, and the healthcare team. This collaborative approach must account for the projected treatment plan, anticipated duration of therapy, patient condition, and concurrent infusion requirements.

Standard 2: Risk Mitigation

Healthcare providers must implement proactive interventions to reduce the risk of side effects and adverse reactions associated with therapeutic phlebotomy. This includes pre-procedural assessment, intraprocedural monitoring, and post-procedural care protocols tailored to individual patient needs.

Standard 3: Medical Waste Management

All medical waste generated during therapeutic phlebotomy, including withdrawn blood, must be disposed of in strict accordance with institutional policies, applicable regulatory requirements, and established infection control guidelines.

Clinical Parameters and Indications

Establishing Treatment Parameters

Prior to initiating therapeutic phlebotomy, clinicians should establish clear treatment parameters that include laboratory values specific to the patient’s diagnosis. Relevant values commonly include hemoglobin, hematocrit, and ferritin levels, though additional markers may be indicated based on the underlying condition (Barbui et al., 2018; Peedin & Karp, 2021; Katsarou et al., 2019).

The treatment protocol should specify threshold laboratory values that indicate when phlebotomy should be initiated and when it may be discontinued, the frequency of procedures, the type of vascular access device to be used, and the volume of blood to be withdrawn at each session. These parameters should be individualized based on diagnosis, disease severity, patient tolerance, and treatment goals (Fuqua et al., 2021; Lima et al., 2019; Kurtin & Lyle, 2018).

Alternative Approaches

Erythrocytapheresis, an apheresis procedure in which red blood cells are selectively extracted while remaining blood components are returned to the patient, may serve as an alternative to traditional therapeutic phlebotomy. This approach is particularly valuable when rapid attainment of treatment goals is necessary to reduce blood viscosity and mitigate thrombotic risk, or when conventional phlebotomy fails to achieve therapeutic objectives. However, clinicians should be aware that apheresis carries higher rates of adverse reactions and significantly greater procedural costs compared to standard phlebotomy (Teofili et al., 2019).

Prevention and Management of Adverse Effects

Common Side Effects

The most frequently encountered complications of therapeutic phlebotomy include hypovolemia, nausea, vomiting, dizziness, syncope, headache, fatigue, and hematoma formation at the access site (Kim & Oh, 2016; Van Buren et al., 2020).

Procedural Safeguards

To minimize the risk of adverse events, the following measures should be implemented:

Positioning: Patients should be placed in a reclining chair or on an examination table or bed throughout the procedure. This positioning reduces the risk of injury in the event of syncope and facilitates venous access (Barbui et al., 2018; Fuqua et al., 2021).

Vital Sign Monitoring: Blood pressure, heart rate, and other relevant vital signs should be assessed before and after the procedure to detect hemodynamic instability promptly (Lima et al., 2019).

Hydration: Oral hydration should be encouraged both before and after the procedure. Oral hydration is preferred over parenteral fluid replacement in most circumstances. When parenteral fluid replacement is prescribed, the type of solution, volume, and infusion rate must be clearly specified (Shimura et al., 2019; Lim et al., 2020).

Anxiety Assessment: Patients should be asked about needle phobia or fear of blood prior to the procedure, as anxiety can exacerbate vasovagal responses and complicate the phlebotomy process.

Post-Procedure Protocol: Following completion of the procedure, patients should remain in a reclining position for several minutes before being assisted to rise slowly. This gradual transition helps prevent orthostatic hypotension and syncope (Kim & Oh, 2016).

Psychosocial Considerations

Self-Harm Risk Assessment

Clinicians must assess patients for a history of self-harm prior to initiating therapeutic phlebotomy. Evidence suggests that therapeutic phlebotomy may inadvertently become a substitute for usual self-harm practices in susceptible individuals. Furthermore, cessation of therapeutic phlebotomy in patients with this history may precipitate an increase in self-injurious behaviors. Appropriate mental health consultation and monitoring should be implemented when this risk is identified (Newham & Khanna, 2019).

Vascular Access Device Selection

The choice of vascular access device should be guided by patient condition, anticipated treatment duration, and compatibility with other infusion therapies the patient may require.

Peripheral Intravenous Catheters

Short peripheral intravenous catheters remain the most common choice for therapeutic phlebotomy. A 16- to 18-gauge device is recommended to facilitate adequate blood flow rates while minimizing hemolysis. The catheter should be inserted immediately before the procedure and removed upon completion (Peedin & Karp, 2021).

Central Vascular Access Devices

When a central vascular access device, including an implanted vascular access port, is already in place, it may be utilized for therapeutic phlebotomy provided that doing so will not compromise other infusion therapies. Coordination with the patient’s care team is essential to ensure that central line use for phlebotomy does not interfere with medication administration, parenteral nutrition, or other critical infusions (Hagle & Mikell, 2014).

Blood Collection Equipment

Appropriate collection receptacles for therapeutic phlebotomy include collection bags designed for volunteer blood donation or bags specifically manufactured for therapeutic phlebotomy procedures. Syringes may also be utilized depending on the vascular access device in use.

Critical Safety Warning: Vacuum bottles must never be used to facilitate blood flow during therapeutic phlebotomy due to the significant risk of air embolism. Only collection systems designed for safe blood withdrawal should be employed.

Patient Education

Comprehensive patient education is essential to ensure informed consent, promote adherence, and optimize outcomes. Education should address the following topics:

Financial Considerations: Patients should understand the anticipated costs of the procedure, including any charges not covered by insurance, frequency of treatments, and potential financial assistance resources.

Quality of Life Impact: Discussion should include how the treatment regimen may affect daily activities, work schedules, and lifestyle factors.

Potential Side Effects: Patients must be informed of common complications including hematoma at the puncture site, dizziness, fainting, headache, nausea, vomiting, and post-procedural fatigue (Van Buren et al., 2020).

Treatment Adherence: The consequences of missing scheduled treatments should be clearly explained, particularly for conditions where regular phlebotomy is essential for disease control.

Activity Restrictions: Any limitations on physical activity before and after the procedure should be communicated, including driving restrictions if applicable.

Combination Therapy

Therapeutic phlebotomy may be employed as a sole treatment modality or in combination with pharmacologic or other therapeutic interventions to achieve optimal disease management. For example, in polycythemia vera, phlebotomy is frequently used alongside hydroxyurea or other cytoreductive agents (Podoltsev et al., 2018; Casu et al., 2021; Ginzburg et al., 2018).

The decision to combine therapies should be individualized based on disease characteristics, treatment response, patient tolerance, and evidence-based guidelines specific to the underlying condition.

Blood Utilization

Emerging evidence suggests that blood collected during therapeutic phlebotomy from certain patient populations, particularly those with hereditary hemochromatosis, may be safe for use in blood transfusion. Studies have demonstrated comparable quality of red blood cell components and platelets from therapeutic donors compared to healthy volunteer donors (Mikaelsdottir et al., 2021; Sut et al., 2017).

Institutional policies and blood banking regulations should guide decisions regarding the disposition of blood collected during therapeutic phlebotomy, including potential eligibility for transfusion use.

References

Barbui T, Passamonti F, Accorsi P, et al. Evidence- and consensus-based recommendations for phlebotomy in polycythemia vera. Leukemia. 2018;32(9):2077-2081. doi:10.1038/s41375-018-0199-5

Casu C, Liu A, De Rosa G, et al. Tmprss6-ASO as a tool for the treatment of polycythemia vera mice. PLoS One. 2021;16(12):e0251995. doi:10.1371/journal.pone.0251995

Fuqua J, Reece J, Sofka S. Successful use of phlebotomy to treat severe secondary polycythemia due to chronic lung disease. Hematol Rep. 2021;13(2):8961. doi:10.4081/hr.2021.8961

Ginzburg YZ, Feola M, Zimran E, Varkonyi J, Ganz T, Hoffman R. Dysregulated iron metabolism in polycythemia vera: etiology and consequences. Leukemia. 2018;32(10):2105-2116. doi:10.1038/s41375-018-0207-9

Hagle M, Mikell M. Peripheral venous access. In: Weinstein SM, Hagle ME, eds. Plumer’s Principles and Practice of Infusion Therapy. 9th ed. Wolters Kluwer/Lippincott Williams & Wilkins; 2014:303-334.

Katsarou MS, Papasavva M, Latsi R, Drakoulis N. Hemochromatosis: hereditary hemochromatosis and HFE gene. Vitam Horm. 2019;110:201-222. doi:10.1016/bs.vh.2019.01.010

Kim KH, Oh KY. Clinical applications of therapeutic phlebotomy. J Blood Med. 2016;7:139-144. doi:10.2147/JBM.S108479

Kurtin S, Lyle L. The role of advanced practitioners in optimizing clinical management and support of patients with polycythemia vera. J Adv Pract Oncol. 2018;9(1):56-66. PMID: 30564468

Lim Z, Bentley P, Olynyk JK. Ensuring donor safety: is venesecting therapeutic donors to haemoglobin levels below blood service guidelines safe? Vox Sang. 2020;115(4):288-292. doi:10.1111/vox.12900

Lima TG, Benevides FLN, Esmeraldo Filho FL, et al. Treatment of iron overload syndrome: a general review. Rev Assoc Med Bras. 2019;65(9):1216-1222. doi:10.1590/1806-9282.65.9.1216

Mikaelsdottir M, Vidarsson B, Runarsson G, et al. A comparison of platelet quality between platelets from healthy donors and hereditary hemochromatosis donors over seven-day storage. Transfusion. 2021;61(1):202-211. doi:10.1111/trf.16176

Newham BJC, Khanna R. The effect of therapeutic phlebotomy for hemochromatosis on non-suicidal self-injury: a case report. Int J Psychiatry Med. 2019;54(1):74-79. doi:10.1177/0091217418791451

Peedin AR, Karp JK. How do I…perform therapeutic phlebotomy? Transfusion. 2021;61(3):673-677. doi:10.1111/trf.16308

Podoltsev NA, Zhu M, Zeidan AM, et al. The impact of phlebotomy and hydroxyurea on survival and risk of thrombosis among older patients with polycythemia vera. Blood Adv. 2018;2(20):2681-2690. doi:10.1182/bloodadvances.2018021436

Shimura M, Nishimata S, Saito N, et al. Ferroportin disease caused by a heterozygous variant p.Cys326Phe in the SLC40A1 gene and the efficacy of therapeutic phlebotomy in children. J Pediatr Hematol Oncol. 2019;41(5):e325-e328. doi:10.1097/MPH.0000000000001301

Sut C, Hamzeh-Cognasse H, Laradi S, et al. Properties of donated red blood cell components from patients with hereditary hemochromatosis. Transfusion. 2017;57(1):166-177. doi:10.1111/trf.13890

Teofili L, Valentini CG, Rossi E, De Stefano V. Indications and use of therapeutic phlebotomy in polycythemia vera: which role for erythrocytapheresis? Leukemia. 2019;33(1):279-281. doi:10.1038/s41375-018-0304-9

Van Buren NL, Hove AJ, French TA, Gorlin JB. Therapeutic phlebotomy for testosterone-induced polycythemia. Am J Clin Pathol. 2020;154(1):33-37. doi:10.1093/ajcp/aqaa019