Frequency of immediate adverse effects associated with therapeutic apheresis

BACKGROUND: Therapeutic apheresis was found to be reasonably safe in prior studies using instruments that are now largely obsolete. The incidence of adverse effects with current instruments and techniques has not been assessed in a large multicenter study. STUDY DESIGN AND METHODS: A survey was conducted in 1995 using a uniform questionnaire that asked about 32 specific events but excluded transient paresthesia and mild vasovagal events. Eighteen centers returned 3429 responses concerning 125 to 500 therapeutic apheresis procedures per center. RESULTS: Two hundred forty-two adverse events were reported in 163 procedures (4.75% of all procedures; 6.87% of first-time procedures and 4.28% of repeat procedures). The numbers (incidence) of selected specific events were transfusion reaction, 56 (51 in plasma exchange [PE] with plasma replacement) (1.6%); citrate-related nausea and/or vomiting, 41 (1.2%); systolic blood pressure <80 mmHg, 34 (1.0%); vasovagal nausea and/or vomiting, 17 (0.5%); pallor and/or diaphoresis, 16 (0.5%); pulse >120, 14 (0.4%); respiratory distress, 9 (0.3%); tetany or seizure, 9 (0.2%); and chills or rigors, 6 (0.2%). Rates for other specific events were < or =0.1 percent. Vasovagal phenomena were more frequent in procedures done in neurologic patients than in those done in hematology or oncology patients (p = 0.011) or renal or rheumatic patients (p = 0.038). Procedure-specific rates were red cell exchange, 8 (10.26%) of 78; PE (plasma), 89 (7.81 %) of 1140; PE (no plasma), 42 (3.35%) of 1255; leukapheresis, 4 (5.71%) of 70; plateletpheresis, 0 of 18; and autologous peripheral blood progenitor cell collection, 11 (1.66%) of 664. Three deaths were reported; all were attributed to primary disease. CONCLUSION: Therapeutic apheresis procedures are relatively safe, with a 4.75-percent overall incidence of mostly reversible adverse effects. Among the most commonly performed procedures, the risk is higher for blood component exchanges, especially if allogeneic red cell or plasma transfusion occurs, and lower for peripheral blood progenitor cell collection.     

The impact of immediate adverse donation reactions on the return of volunteers undergoing platelet apheresis

IntroductionImmediate adverse reactions experienced during donation decrease return rates among whole-blood donors, but little is known about this effect among platelet apheresis donors. We investigated the impact of immediate adverse reactions on the return rates of volunteer apheresis platelet donors.MethodsIn a sample of 4108 consecutive platelet apheresis donors seen from August 2016 through June 2019, we evaluated whether immediate adverse reactions were associated with returning for a subsequent platelet apheresis donation within a 12-month period. We used propensity score matching to compare donors with and without adverse reactions.ResultsAn immediate adverse reaction occurred in 312 (7.6%) donors; 98.5% were mild, and 0.3% were severe. Of the original 4108 platelet apheresis donors, only 3211 (72.3%) returned for a subsequent donation within 12 months. Experiencing an immediate adverse reaction during the donation process significantly decreased the return rate for a subsequent donation [HR= 0.74 (0.63–0.87)], especially among female donors [HR= 0.70 (0.53–0.93)], donors aged < 30 years [HR= 0.71 (0.54–0.94)], with a high school educational level [0.63 (0.49–0.81)], donors donating for the first time [HR= 0.73 (0.59–0.90)], and repeat donors with a previous platelet apheresis donation more than 180 days prior [HR= 0.68 (0.50–0.93)].ConclusionEven mild adverse events reduce the return rates for a subsequent donation among platelet apheresis donors. Female donors, younger donors, and first-time donors are at higher risk of not returning after an immediate adverse reaction. Preventing the incidence of immediate adverse reactions during platelet apheresis donation may increase the rate of donor retention.     

Moderate and severe adverse events associated with apheresis donations: incidences and risk factors

BACKGROUND: The goal of this observational retrospective study was to evaluate various donor and procedural variables as potential risk factors for different types of moderate to severe adverse events (AEs) during apheresis collections. STUDY DESIGN AND METHODS: Data on all apheresis collections performed on Trima Accel (TA; CaridianBCT) instruments over a 28‐month period were extracted from a donor database (Vista Information System, CaridianBCT) and reviewed along with AE reports from the same period. Donor and procedural variables were compared among uneventful procedures and those that resulted in various types of moderate to severe AEs, including presyncopal or syncopal (PS) episodes, citrate reactions (CR), reactions with both components (PS + CR), and self‐reported incidents of significant venipuncture‐related vascular injuries (VIs). RESULTS: A total of 59 moderate to severe AEs occurred among 15,763 procedures (0.37%), including 19 PS, 4 CR, 17 PS + CR, 12 VI, and 7 miscellaneous reactions. Greater blood loss and lower net fluid balance were associated with PS; female sex, older age, and smaller total blood volume (TBV) were associated with CR; and development of VI may be associated with female sex and smaller TBV. Younger age was not a risk factor for AEs. CONCLUSIONS: Apheresis collections performed by TA instruments are safe with a low incidence of significant AEs. Various types of AEs have different predisposing factors. Apheresis may be a safer option for donors with risk factors for PS reactions associated with whole blood collections, such as younger age, female sex, and small TBV.     

机采成分献血回顾研究

目的 了解年度机采血小板采血数量和献血人群及各血型采供比例情况,分析临床用血规律,为机采血小板无偿献血者招募和供血服务及建立机采快检提供参考依据.方法 通过2009年机采血小板采供血数据,计算采供血量,分析机采成分血使用情况及各血型使用的构成比例,以及献血者年龄血型、不同年龄段血液报废率等.结果 2009年采集5823人次,采集机采血小板8819治疗量.献血人员构成以21至25Y人员为主,共采集3257人次,占所有机采献血人次的55.9%（3257/5823）,同时其淘汰人次也相对较高40.4%[（18＋3）/（49＋3）],其次为26至30Y的献血者占12.3%（716/5823）.男性献血者占献血人次的74.3%（4325/5823）,女性献血者占25.7%（1498/5823）.各种血型年度间构成比例基本稳定,变化不大,其采集比例顺序是：O型、B型、A型、AB型,年度内构成比例基本稳定,各月份间比例变化不大.结论 研究结果对今后自愿无偿机采献血者的招募,采血计划的制定,机采血小板的储备具有重要的参考价值和指导意义.     

Severe citrate toxicity complicating volunteer apheresis platelet donation

We report a case of severe citrate toxicity during volunteer donor apheresis platelet collection. The donor was a 40-year-old female, first-time apheresis platelet donor. Past medical history was remarkable for hypertension, hyperlipidemia, and depression. Reported medications included bumetanide, pravastatin, and paroxetine. Thirty minutes from the start of the procedure, the donor noted tingling around the mouth, hands, and feet. She then very rapidly developed acute onset of severe facial and extremity tetany. Empirical treatment with intravenous calcium gluconate was initiated, and muscle contractions slowly subsided over approximately 10 to 15 minutes. The events are consistent with a severe reaction to calcium chelation by sodium citrate anticoagulant resulting in symptomatic systemic hypocalcemia. Upon additional retrospective analysis, it was noted that bumetanide is a loop diuretic that may cause significant hypocalcemia. We conclude that careful screening for medications and underlying conditions predisposing to hypocalcemia is recommended to help prevent severe reactions due to citrate toxicity. Laboratory measurement of pre-procedure serum calcium levels in selected donors may identify cases requiring heightened vigilance. The case also illustrates the importance of maintaining preparedness for managing rare but serious reactions in volunteer apheresis blood donors.     

Red cell apheresis in autologous preoperative blood donation.

Preoperative autologous blood donation (PAD) is a commonly used technique for elective surgical procedures with a predictable blood loss. The conventional method is to collect one unit whole blood weekly several times within the shelf-life of red cell concentrates. Erythrapheresis with the Haemonetics cell separator MCS-3p or plus makes it possible to collect two units of red cells in one single session and with this option the time interval and operation can be prolonged to three weeks to improve erythropoiesis. 295 patients, who were scheduled for hip replacement or knee endoprothesis were evaluated retrospectively calculating the net profit of red cells after donating two units of red cells by erythrapheresis. The median net profit of red cells was 140 ml red cells but with a wide range. The patients who profit most of PAD were those with a predonation hct below 42% who had net profits up to 300 ml red cells due to an increased erythropoiesis, which compensate for the withdrawal of the red cells. Thus erythrapheresis with the Haemonetics MCS-3p or Haemonetics MCS plus is recommended for patients with a predonation hct lower than 42% and who can be scheduled for PAD at least 3 weeks before operation when two units of red cells are the target for PAD.     

Utility of red blood cell apheresis in autologous blood donation

Although autologous blood donation is an alternative to allogeneic transfusion, some authors had questioned its cost-effectiveness. New techniques, like red blood cell apheresis could improve the cost-effectiveness of autologous blood transfusion, therefore we have valued the efficiency of this procedure in autologous blood donation. MATERIALS AND METHODS: We studied 131 patients undergoing different types of surgery who entered the preoperative autologous blood donation program over a one year period. Apheresis was performed with the MCS 3p from Haemeonetics. RESULTS: We were able to collect 304 red blood cell units from 131 patients. The average yield per procedure was two units (88 cases, 67.2%). In 41 patients (31.3%), we collected 3 units and, in two cases, 4 units were collected. The mean volume of the units was 255 (191-280). 18 (13.7% patients had an adverse reaction. Most of these were mild. Only in one case was it necessary to stop the procedure. 202 units (66.4%) were transfused to 97 patients (74%). 12 (9.2%) patients also used allogeneic transfusions (mean units: 0.18+/-0.05 with a range 1-5). CONCLUSION: Red blood cell apheresis is a useful procedure in autologous blood donation.     

MDR1 gene polymorphisms are associated with neuropsychiatric adverse effects of mefloquine

BACKGROUND: Mefloquine, a drug used for treatment and prophylaxis of malaria, is known for its neuropsychiatric adverse effects. We hypothesized that neuropsychiatric adverse effects of mefloquine are associated with polymorphisms in the MDR1/ABCB1 gene that encodes for the efflux pump P-glycoprotein. METHODS: The association between MDR1 C1236T, G2677T, and C3435T single-nucleotide polymorphisms and the occurrence of neuropsychiatric adverse effects was examined in a prospective cohort study of 89 healthy white travelers taking mefloquine. RESULTS: Of the subjects, 27 (28%) reported neuropsychiatric adverse effects, women significantly more frequently than men. Allele frequencies of the C1236T, G2677T, and C3435T polymorphisms were similar to those found in other white populations, and there was no significant association between any of the individual polymorphisms and neuropsychiatric adverse effects. However, women with the 1236TT, 2677TT, and 3435TT genotypes had a higher risk of neuropsychiatric adverse effects than the reference groups of women with heterozygous and homozygous CC or GG genotypes, with odds ratios of 6.3 (95% confidence interval [CI], 1.1-36.9), 10.5 (95% CI, 1.1-100.6), and 5.4 (95% CI, 1.1-30.0), respectively. The association for women homozygous for the 1236-2677-3435 TTT haplotype was even stronger (P = .004) than the effect of any of the individual polymorphisms. No associations with mefloquine blood levels were observed. CONCLUSION: In this study the MDR1 1236TT, 2677TT, and 3435TT genotypes, along with the 1236-2677-3435 TTT haplotype, were associated with neuropsychiatric adverse effects of mefloquine in women. MDR1 polymorphisms may play an important role in predicting the occurrence of neuropsychiatric adverse effects of mefloquine, particularly in female travelers.     

Incidence of adverse reactions associated with acupuncture

OBJECTIVES: To determine the type, severity, and incidence of acupuncture adverse reactions that are observed in standard practice. DESIGN: A survey based on observation and interview by the therapists. SETTING: Tsukuba College of Technology Clinic in Japan. SUBJECTS: All patients who underwent acupuncture treatment during a period of 4 months from April to July 1998. OUTCOME MEASURES: Type, severity, and incidence of acupuncture adverse reactions. RESULTS: A total of 391 patients were treated in 1,441 sessions, involving a total of 30,338 needle insertions. The incidence of recorded systemic reactions in individual patients was: tiredness (8.2%); drowsiness (2.8%); aggravation of preexisting symptoms (2.8%); itching in the punctured regions (1.0%); dizziness or vertigo (0.8%); feeling of faintness or nausea during treatment (0.8%); headache (0.5%); and chest pain (0.3%). The incidence of recorded local reactions, expressed as a percentage of needle insertions, was: minor bleeding on withdrawal of the needle (2.6%); pain on insertion of the needle (0.7%); petechia or ecchymosis (0.3%); pain or ache in the punctured region after the treatment (0.1%); subcutaneous haematoma (0.1%); and pain or discomfort in the punctured region during the needle retention (0.03%). CONCLUSION: Although some adverse reactions associated with acupuncture were common even in standard practice, they were transient and mild compared to cases such as pneumothorax, cardiac injury, infection, or spinal lesions reported in other studies.     

Appetite and adverse effects associated with radiation therapy in patients with head and neck cancer

PurposeThe relationship between radiation treatment and adverse effects resulting in changes in appetite was studied in patients with head and neck (H&N) cancer.Methods and samplePath analysis was used to evaluate the following factors in 117 patients receiving radiation therapy for H&N cancer: daily fluctuations in saliva production, analgesic use, frequency of oral care, subject characteristics, and appetite.ResultsAt 20 Gy of radiation, appetite was affected by Brinkman index value, age, and sensitivity to taste (R² = 0.48, p < 0.001); at 30 Gy of radiation, appetite was affected by frequency of oral care, xerostomia symptoms, age, sensitivity to taste, and oral mucositis (R² = 0.52, p < 0.001); and at 50 Gy of radiation, appetite was affected by low saliva production in the morning, frequency of oral care, xerostomia symptoms, sensitivity to taste, analgesic use, and oral mucositis (R² = 0.62, p < 0.001).ConclusionsThe results of this study suggest that care taken to avoid a decrease in appetite due to adverse effects of radiation therapy should differ according to the dosage and schedule of radiation therapy. These findings represent important data for health care professionals to understand and support appropriate dietary intake and improved quality of life for H&N cancer patients receiving radiation therapy.     

Atypical reactions associated with use of angiotensin-converting enzyme inhibitors and apheresis

BACKGROUND: Anaphylactic or atypical reactions, characterized by flushing, hypotension, dyspnea, and bradycardia, have been reported in patients undergoing hemodialysis, low-density lipoprotein apheresis, IgG affinity column apheresis, therapeutic plasma exchange, and desensitization immunotherapy while receiving angiotensin-converting enzyme (ACE) inhibitor therapy. STUDY DESIGN AND METHODS: Records were reviewed of 299 consecutive patients undergoing therapeutic plasma exchange with colloid replacement at the University of North Carolina Hospitals from September 1981 through December 1993. Charts were selected for further analysis if atypical reactions (flushing or hypotension defined as a mean decrease in blood pressure of 20 torr or greater) occurred during apheresis or if there was concurrent administration of an ACE inhibitor. RESULTS: Fourteen (4.7%) of 299 patients were receiving ACE inhibitor therapy at the time of apheresis; all 14 experienced an atypical reaction. In contrast, 20 (7%) of 285 patients not receiving ACE inhibitors developed atypical reactions (p < 0.001). The 14 ACE inhibitor patients accounted for 41 percent (14/34) of all patients having atypical reactions during apheresis. CONCLUSION: Patients receiving ACE inhibitor therapy who are undergoing therapeutic plasma exchange with albumin replacement solutions are at high risk (100%) for atypical reactions. It is recommended that ACE inhibitors be withheld for at least 24 hours before that procedure.