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This report is being filed to provide additional information in h.6 and h.10.Investigation: the authors performed a total of 672 therapeutic plasma exchange procedures in 99 pediatric patients (11% referred from icu) over a period of 19 y with a mean age of the patient as 7.0 ± 3.11 y.Male to female ratio was 2.3 : 1.The demographic details of the patients are shown in table 1.Tpe was done for various indications in the authors patients like hematological (n = 68), renal (n = 12), neurology (n = 18), and hepatology (n = 1).The most common diagnosis for the procedure in the present study was atypical hemolytic uremic syndrome (63.6%).Other diagnoses are shown in table 2 as per their asfa category.Inlet flow rate for tpe procedure ranged from 6.0 to 23.6 ml/min with a mean flow of 16.45 ± 4.82 ml/min.Timings for procedure ranged from 74 to 172 min.Out of a total of 672 procedures, adverse events were observed in 34 procedures (5%).The most common adverse event was replacement fluid¿related [allergic reaction presenting as urticaria, rash and itching in 2.24% procedures and febrile non hemolytic transfusion reaction (fnhtr) in 0.41%] followed by procedure-related complication namely hypotension (1.04%) and symptomatic hypocalcemia presenting as pain abdomen, nausea, and vomiting in 1.04% of procedures done.Venous access-related complications (intravenous-line blockage) was observed in 0.59% of procedures as shown in fig.1.Replacement fluid used was fresh frozen plasma (ffp) in 77.8% patients and human serum albumin (hsa) in 22.2% patients.All adverse events were of grade 3 severity, which were managed as per departmental standard operating procedures (sops) and procedures were completed successfully except in one where patient developed bradycardia (hr < 45 beats/min) after replacing 50% of his plasma volume with 0.9% normal saline and 5% human serum albumin in ratio of 70 : 30.The procedure was terminated, patient was resuscitated, recovered, and shifted back to intensive care unit (icu).The procedure was going on cs 3000 plus after manual priming with prbc.No mortality was observed during the procedures.The authors also tried to find out the correlation between physical parameters of the patient and procedural parameters with the rate of adverse events and found that there was no statistically significant correlation of adverse events with age, sex, type of apheretic device used for procedure, and different indications for plasma exchange however significant correlation was found with weight (p = 0.045) and total blood volume of the patient (p = 0.04).Also, the rate of adverse events was significantly correlated with increasing number of procedures (p = 0.000) and replacement fluid (ffp) (p = 0.04) as shown in table 3.Another challenge faced in these patients was maintaining adequate access flow rates due to their poor venous caliber.The large bore needle of 16 gauge integrated to the disposable tpe kits is not suitable for venipuncture in the pediatric population.So, central lines are always preferred in these patients to have a continuous flow for maintaining the interface for different cellular and noncellular components of the blood.However, these may get thrombosed or infected which can affect the procedure schedule.The commonest adverse events were related to venous access (50% patients) followed by symptomatic hypocalcemia whereas in the present study, the authors observed symptomatic hypocalcemia in 1.04% procedures and adverse events related to venous access as 0.59% only.The authors used ffp as replacement fluid in their patients with thrombotic microangiopathy as per the recommendations of asfa guidelines; hence, majority of adverse events in the patient were related to the type of replacement fluid with statistically significant correlation.The commonest adverse reaction observed in the present study was mild allergic reactions to plasma proteins of ffp and is similar to findings by sinha et al.And jukic et al.Who observed adverse events in 8.5% of procedures where ffp was used as replacement fluid as compared to 3.8% with albumin.The authors also observed a significant correlation of rate of adverse event with the number of procedures and since most of the patients were of thrombotic microangiopathy and underwent more than 5 procedures, so the adverse events were higher in these patients (24/34 total adverse events) as compared to other diagnoses.According to the aabb circular of information for the use of human blood components (revised 2017), allergic reactions frequently occur (ie, 1-3% of plasma-containing components) as mild or self-limiting urticaria or wheezing that usually respond to antihistamines.More severe manifestations, including respiratory and cardiovascular symptoms, are more consistent with anaphylactoid/anaphylactic reactions and may require more aggressive therapy (see below).No laboratory procedures are available to predict these reactions.Anaphylactic reactions, characterized by hypotension, tachycardia, nausea, vomiting and/or diarrhea, abdominal pain, severe dyspnea, pulmonary and/or laryngeal edema, and bronchospasm and/or laryngospasm, are rare (<10/100,000 transfused units) but dangerous complications requiring immediate treatment with epinephrine.While these reactions have been reported in iga-deficient patients with anti-iga antibodies and patients with haptoglobin deficiency, most reactions are idiosyncratic and not associated with a specific serum protein deficiency, polymorphism, or identifiable cause.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paresthesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.According to therapeutic apheresis: a physician's handbook, adverse effects related to vascular access are a frequent concern.Hemorrhage or pneumothorax or both may complicate cvc insertion, while thrombosis and infection are the most frequently observed complications of prolonged central venous access.During a dressing change, the site should be cleaned and observed for signs of infection such as redness, swelling, drainage, and foul odor.If an infection is suspected, cvc removal should be considered, and the patient should be treated for infection as appropriate.The cause of a cvc flow problem may sometimes be difficult to determine, although patient repositioning will sometimes improve flow.A common situation is that the cvc can be flushed without resistance but does not yield blood return; this scenario may be the result of kinking, poor positioning, intraluminal clots, or venous thrombosis.Blocked cvcs can sometimes be cleared with a fibrinolytic agent such as tpa.The placement of a cvc is considered by some to be the greatest risk related to the apheresis procedures, and it should be avoided if the procedure can be performed using peripheral iv.According to the aabb circular of information for the use of human blood components (revised 2017), febrile nonhemolytic reactions are typically manifested by a temperature elevation of >1c or 2f occurring during or within 4 hours after a transfusion and in the absence of any other pyrexic stimulus or active warming.Febrile reactions may occur in less than 1% of transfusion of leukocyte-reduced red cell components and about 5% of leukocyte-reduced apheresis platelet components.Febrile reactions occur more frequently in patients receiving non-leukocyte-reduced components and those previously alloimmunized by transfusion or pregnancy.Antipyretics usually provide effective symptomatic relief.Patients who experience repeated, severe febrile reactions may benefit from receiving leukocyte-reduced components.If these reactions are caused by cytokines in the component, prestorage leukocyte reduction may be beneficial.Since this is a retrospective study which evaluated the safety of therapeutic plasma exchange in pediatric populations over a period of 19 y (2001¿2019), the lot numbers were not provided; therefore, a disposable lot history search could not be conducted.Article citation: hans et al 2021.Centrifugal therapeutic plasma exchange in pediatric patients.The indian journal of pediatrics (august 2021) 88(8):757¿763.Https://doi.Org/10.1007/s12098-020-03657-6 root cause: a root cause assessment was performed for the allergic reaction.The reported adverse events are common side effects of transfusion and apheresis procedures.The authors stated that "mild allergic reactions to plasma proteins in fresh frozen plasma".A root cause assessment was performed for the hypotension.Based on the available information a definitive root cause could not be determined.Hypotension is a common side effect of therapeutic apheresis procedures.They are typically caused by the patient's disease state, the blood loss, the length of the procedure, the patient's sensitivity to the procedure and/or the hemodynamic stress of the procedure.A definitive root cause for the reported citrate reactions could not be determined.These reactions occur due to decreased ionized calcium in circulation as a result of exogenous citrate administered during the apheresis procedure and are influenced by patient physiology, the patient's disease state, the rate of ac infusion, the citrate contents in the replacement fluid, and/or the length of the procedure.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the ac infusion rate.A root cause assessment was performed for the line blockage.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * poor maintenance of the catheter.* hypercoagulopathy associated with the patient's underlying disease state.A root cause assessment was performed for the febrile non-hemolytic transfusion reaction.The reported adverse events are common side effects of transfusion.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * the action of antibodies against white cells or the action of cytokines either present in the transfused component or generated by the recipient in response to transfused elements.* patients received non-leukocyte-reduced components * patients were previously alloimmunized by transfusion or pregnancy.
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