Asunto(s)
Eliminación de Componentes Sanguíneos , Intercambio Plasmático , Adulto , Enfermedades Autoinmunes/terapia , Eliminación de Componentes Sanguíneos/efectos adversos , Eliminación de Componentes Sanguíneos/métodos , Niño , Ensayos Clínicos como Asunto , Enfermedades Hematológicas/terapia , Humanos , Enfermedades Metabólicas/terapia , Enfermedades del Sistema Nervioso/terapia , Intercambio Plasmático/efectos adversos , Intercambio Plasmático/métodos , Enfermedades Reumáticas/terapiaAsunto(s)
Eliminación de Componentes Sanguíneos , Enfermedades Renales/terapia , Enfermedades Metabólicas/terapia , Intercambio Plasmático , Adulto , Enfermedad por Anticuerpos Antimembrana Basal Glomerular/inmunología , Enfermedad por Anticuerpos Antimembrana Basal Glomerular/fisiopatología , Enfermedad por Anticuerpos Antimembrana Basal Glomerular/terapia , Anticuerpos Anticitoplasma de Neutrófilos/inmunología , Enfermedades Autoinmunes/inmunología , Enfermedades Autoinmunes/fisiopatología , Enfermedades Autoinmunes/terapia , Membrana Basal/inmunología , Niño , Ensayos Clínicos como Asunto , Sobredosis de Droga/terapia , Enfermedad de Fabry/terapia , Glomerulonefritis/inmunología , Glomerulonefritis/fisiopatología , Glomerulonefritis/terapia , Glomeruloesclerosis Focal y Segmentaria/tratamiento farmacológico , Glomeruloesclerosis Focal y Segmentaria/terapia , Rechazo de Injerto/terapia , Trasplante de Corazón/inmunología , Síndrome Hemolítico-Urémico/fisiopatología , Síndrome Hemolítico-Urémico/terapia , Humanos , Hiperlipoproteinemia Tipo II/sangre , Hiperlipoproteinemia Tipo II/tratamiento farmacológico , Hiperlipoproteinemia Tipo II/terapia , Inmunosupresores/uso terapéutico , Glomérulos Renales/inmunología , Trasplante de Riñón/inmunología , Fallo Hepático/terapia , Regeneración Hepática , Trasplante de Hígado , Errores Innatos del Metabolismo/terapia , Fotoféresis , Intoxicación/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Enfermedad de Refsum/terapiaRESUMEN
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.
Asunto(s)
Eliminación de Componentes Sanguíneos/efectos adversos , Transfusión de Componentes Sanguíneos/efectos adversos , Intercambio Plasmático/efectos adversos , Anticoagulantes/efectos adversos , Bancos de Sangre/estadística & datos numéricos , Eliminación de Componentes Sanguíneos/instrumentación , Citratos/efectos adversos , Transfusión de Eritrocitos/efectos adversos , Humanos , Hipotensión/epidemiología , Hipotensión/etiología , Náusea/epidemiología , Náusea/etiología , Fotoféresis/efectos adversos , Plasma , Trastornos Respiratorios/epidemiología , Trastornos Respiratorios/etiología , Convulsiones/epidemiología , Convulsiones/etiología , Tiritona , Encuestas y Cuestionarios , Síncope Vasovagal/epidemiología , Síncope Vasovagal/etiología , Vómitos/epidemiología , Vómitos/etiologíaRESUMEN
BACKGROUND: Apheresis donation is considered safe, but the incidence of adverse effects has not been determined in a large multicenter series of donations with modern instruments. STUDY DESIGN AND METHODS: The Hemapheresis Committee of the American Association of Blood Banks devised a uniform questionnaire that asked about 32 specific adverse effects. Transient paresthesia and mild vasovagal events were excluded. A survey was conducted in 1995; 17 centers returned 19,611 responses concerning 250 to 2,000 consecutive apheresis donations per center. RESULTS: Six hundred adverse effects were reported in 428 donations (2.18% of donations). Pain or hematoma at a venipuncture site was the most common response (1.15% of donations); only 203 donations had other (nonvenipuncture) adverse effects (1.04%). Total and nonvenipuncture rates were, respectively, 4.84 and 2.92 percent for 2,295 first donations and 1.78 and 0.77 percent for 17,303 repeat donations (p < 0.001). Rates of nonvenipuncture symptoms in first and repeat donations were, respectively, citrate-induced nausea and/or vomiting, 0.87 and 0.27 percent; tetany, 0.09 and 0.04 percent; pallor and/or diaphoresis, 1.87 and 0.32 percent; vasovagal nausea and/or vomiting, 0.87 and 0.13 percent; syncope and/or seizure, 0.39 and 0.04 percent; and chills and/or rigors, 0.31 and 0.01 percent. The overall rate of donor unconsciousness was 0.08 percent. Hemolysis was reported twice. Clotting or leakage occurred in 0.08 percent of donations, and inability to return blood occurred in 0.16 percent. No life-threatening adverse effects were reported. Procedure-specific nonvenipuncture rates were 1.05 percent of 17,584 platelet donations, 0.67 percent of 594 white cell donations, and 0.37 percent of 1,354 plasma donations. Center-specific rates varied from 0.32 to 6.81 percent of donations for total adverse effects and from 0.11 to 2.92 percent of donations for nonvenipuncture events. CONCLUSION: Apheresis donation is a safe undertaking, suitable for voluntary blood donors, with a very low risk of serious adverse effects. The risk of unconsciousness is lower than that found in many studies of whole-blood donation.
Asunto(s)
Eliminación de Componentes Sanguíneos/efectos adversos , Donantes de Sangre , Citratos/efectos adversos , Hematoma/etiología , Humanos , Estudios Multicéntricos como Asunto , Náusea/inducido químicamente , Flebotomía/efectos adversos , Flebotomía/instrumentación , Plasmaféresis/efectos adversos , Plaquetoferesis/efectos adversos , Encuestas y Cuestionarios , Vómitos/inducido químicamenteRESUMEN
Human CD34+ cells purified from frozen mobilized peripheral blood apheresis products (n = 7) were studied immediately (freshly isolated) or refrozen and studied after > 30 days storage in liquid nitrogen (refrozen/thawed). The proliferation and differentiation of freshly isolated or refrozen/thawed CD34+ cells were examined after 10 days of serum-supplemented suspension culture with recombinant human hematopoietic growth factors. The proliferative capacity (fold increase) of the refrozen/thawed CD34+ cells (mean +/- SD, 54.3 +/- 34.3) was comparable to the freshly isolated CD34+ cell cultures (49.0 +/- 42.4). Two-color flow cytometry of the CD34+ cultured cell populations, fresh and refrozen/thawed, displayed typical patterns of neutrophil differentiation into CD15/CD11b neutrophil precursors. The colony-forming ability of freshly isolated and refrozen/thawed CD34+ cells showed no significant differences (p > 0.05) in the total number or type of colony-forming units (CFU-GM, CFU-M, BFU-E, CFU-GEMM) obtained. In addition, the cloning efficiencies of freshly isolated (19.5 +/- 7.6%) and refrozen/thawed CD34+ cells (21.9 +/- 12.7%) were comparable (p = 0.366). These data suggest that CD34+ cells enriched from frozen apheresis blood products can be either used immediately or stored in liquid nitrogen and thawed with minimal effect on their ability to proliferate and differentiate in liquid culture.
Asunto(s)
Antígenos CD34/análisis , Antígenos CD/análisis , Criopreservación , Células Madre Hematopoyéticas/citología , Neoplasias/sangre , Eliminación de Componentes Sanguíneos/métodos , Diferenciación Celular/efectos de los fármacos , División Celular/efectos de los fármacos , Células Cultivadas , Ensayo de Unidades Formadoras de Colonias , Factores Estimulantes de Colonias , Técnicas de Cultivo/métodos , Femenino , Citometría de Flujo , Factores de Crecimiento de Célula Hematopoyética/farmacología , Células Madre Hematopoyéticas/efectos de los fármacos , Humanos , Neoplasias/terapia , Proteínas Recombinantes/farmacologíaRESUMEN
Ultraviolet-B (UVB) irradiation of blood constituents intensifies their anti-rejection effect in pretransplant donor-specific transfusions. UVB-induced inhibition of the mixed lymphocyte reaction (MLR) between UVB-irradiated donor cells and prospective recipient cells is a predicator of this anti-rejection effect. In order to define the dose-response relationship between the incident UVB irradiation on leukocyte concentrates and subsequent inhibition of their MLR responses, we collected 4 +/- 2 x 10(9) leukocytes (93 +/- 7% lymphocytes) in 200 ml plasma from each of three volunteers by leukapheresis and exposed them to rapid, serial doses of UVB irradiation which was delivered by a blood product irradiator (4R4440 UVB Irradiator, Baxter, Inc) with aliquots removed between doses. Lymphocytes from each aliquot were placed in MLR with panel donors and studied in three groups: 1) the panel donor cells were gamma-irradiated (1,500 rads) (i.e., only the UVB-irradiated cells could proliferate), 2) the UVB-irradiated cells were gamma-irradiated (i.e., only the panel lymphocytes could proliferate), and 3) no gamma-irradiation (i.e., both cell populations could proliferate). Each group had a similar UVB dose-related diminution in the MLR (p = .79, ANOVA). A single dose of 6 J/cm2 extinguished the MLR to baseline in all groups. This dose should theoretically prevent transfused cells from producing either graft-versus-host disease or allosensitization, and might heighten their tolerogenic effect. This dose will be employed in our study of donor-specific leukocyte transfusion in clinical renal transplantation.
Asunto(s)
Leucaféresis , Linfocitos/efectos de la radiación , Relación Dosis-Respuesta en la Radiación , Humanos , Tolerancia Inmunológica , Transfusión de Leucocitos , Prueba de Cultivo Mixto de Linfocitos , Linfocitos/inmunología , Rayos UltravioletaRESUMEN
Reactions to human serum albumin (HSA) in therapeutic plasma exchange (TPE) are rare. Nevertheless, older literature describes possible adverse effects, including specific immune responses to albumin or other proteins, and reactions due to contaminating organisms or pyrogen. During an eight day period three patients in our unit had unusual reactions after infusion of 1.5-2 L of HSA. Patient 1 had trembling that persisted for 20 min. Patient 2 had shaking for 40 min despite calcium gluconate infusion, and fever to 100.8 degrees F. Patient 3 had severe rigors that subsided after 90 min when meperidine was finally given, and fever to 103.5 degrees F. Record reviews revealed that all three patients had received HSA from the same lot, and that only one other TPE patient had received HSA from that lot. Neither our pharmacy nor the manufacturer was aware of other reactions associated with that lot. Material from a bottle only partially infused to patient 3 was negative in culture and was negative for pyrogen when retested by the manufacturer. Nevertheless, because patients 1 and 2 had each had multiple previous uneventful TPEs and because all three patients tolerated subsequent TPEs without incident when another brand of HSA was used, we conclude that these patients had pyrogen reactions to the implicated HSA lot. This experience illustrates the value of cluster recognition in arousing suspicion of unusual reactions to HSA and the value of recorded lot numbers in pursuing such suspicions. Apheresis personnel should be aware of the potential for pyrogen reactions with HSA and should record lot numbers of all fluids infused during TPE.
Asunto(s)
Fiebre/inducido químicamente , Intercambio Plasmático/efectos adversos , Albúmina Sérica/efectos adversos , Adulto , Anciano , Femenino , Humanos , Prueba de Limulus , Persona de Mediana EdadRESUMEN
PURPOSE: We investigated the role of high-dose chemotherapy and autologous bone marrow transplantation (ABMT) as the initial systemic treatment in patients with hormone-unresponsive metastatic breast cancer. We studied a regimen involving a split-course schedule using sequential administration of two pairs of alkylating agents separated by 5 days of rest. The rest period was intended to provide time for recovery from the treatment-immediate adverse effects, thereby allowing further dose escalation. PATIENTS AND METHODS: The treatment consisted of thiotepa 225 to 300 mg/m2/d (days - 11 to -9), cisplatin 50 to 100 mg/m2/d (days - 11 and -3), and cyclophosphamide 60 mg/kg/d (days - 3 and -2). Dose escalation was performed in the initial 15 patients before reaching dose-limiting toxicities. When feasible, responding patients received posttransplant irradiation to sites of residual or prior bulky disease. Patients with bone marrow or CNS involvement, prior pelvic irradiation, or age greater than 55 years were excluded. RESULTS: Thirty-nine patients with measurable or assessable tumor were enrolled: 23 with visceral metastases, 11 with only soft tissue disease, and five with skeletal involvement. Twenty-five patients had received no chemotherapy for metastatic disease before transplantation. The dose-limiting toxicities of this therapy were renal and gastrointestinal. Six patients died from complications: four of a fungal infection and two of hemorrhage. A complete response was achieved in 14 patients (36%), three of whom are free of disease at 79+, 55+, and 40+ months after transplantation. Ten of 25 patients not treated with standard-dose chemotherapy for metastatic disease achieved a complete response (40%). The three patients in continuous remission were in the untreated relapse group. CONCLUSION: This single high-dose treatment achieved a relatively high complete response rate in patients with metastatic breast cancer and may have cured some of them. On the other hand, the split-course dose schedule as tested here did not permit significant dose-intensification.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Trasplante de Médula Ósea , Neoplasias de la Mama/terapia , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/patología , Cisplatino/administración & dosificación , Terapia Combinada , Ciclofosfamida/administración & dosificación , Esquema de Medicación , Femenino , Humanos , Persona de Mediana Edad , Metástasis de la Neoplasia , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
Packed red cells (RBC) are customarily infused slowly to allow time for re-equilibration of intravascular volume, but they may be given rapidly for convenience during hemodialysis or partial RBC exchange when blood volume can be adjusted extracorporeally. We describe an apheresis procedure for rapid transfusion of RBC to patients with chronic anemia in which an equivalent volume of recipient plasma is withdrawn as donor RBC are infused. Fifteen such procedures, transfusing 3 to 5 RBC units each, have been performed on nine patients (4 of them outpatients) with either COBE Spectra or COBE 2997. Mean +/- SD procedure duration was 1.79 +/- .44 hr; patient hemoglobin rose from 7.3 +/- 1.5 to 12.0 +/- 1.5 g/dl. Comparison to conventional transfusion was possible for nine procedures on six patients in which rapid transfusion required .52 +/- .12 vs. 2.70 +/- .37 hr per unit (P < .001) and raised hemoglobin by 1.22 +/- .30 vs .88 +/- .34 g/dl per unit (P < .02). Pink plasma noted during one procedure was attributable to infusion of an older AS-1 unit with extensive storage hemolysis. Rapid transfusion was subjectively well tolerated. Immediate post-procedure systolic blood pressures did not differ significantly from baseline, although one hypertensive patient had headache followed by increased blood pressure 4 hours after a procedure. We conclude that rapid transfusion of RBC is a technically feasible and more time efficient means for RBC transfusion. It is particularly attractive in the outpatient setting, and could also prevent fluid overload associated with RBC transfusion in some volume-sensitive patients.
Asunto(s)
Anemia/terapia , Eliminación de Componentes Sanguíneos , Transfusión de Eritrocitos/métodos , Adulto , Anciano , Anemia/sangre , Anemia/fisiopatología , Presión Sanguínea/fisiología , Femenino , Hemodinámica/fisiología , Hemoglobinas/metabolismo , Humanos , Masculino , Persona de Mediana Edad , Factores de TiempoRESUMEN
Modest success has been achieved with the use of high-dose cytotoxic therapy and bone marrow transplantation in solid tumors. Patient outcome can potentially be improved with further intensification of the therapy. The rapid hematologic recovery achieved with mobilized peripheral blood progenitor cells (PBPC) may reduce the toxicity of transplantation enabling the use of sequential courses of myeloablative therapy. We report on 42 patients with solid tumors enrolled in a tandem transplant protocol involving the use of PBPC mobilized with cyclophosphamide (4 g/m2), etoposide (1 g/m2), and granulocyte-colony-stimulating factor (G-CSF: 10 micrograms/kg/day). This regimen significantly increased the number of circulating progenitor cells; only 1-2 aphereses were sufficient to collect 2.5 x 10(8)/kg mononuclear cells, our goal for each transplant course. The median number of circulating colony-forming units (CFU) and CD34+ cells obtained for each transplant course were 70.3 x 10(4)/kg, and 11.7 x 10(6)/kg, respectively. There was a significant correlation between the numbers of CD34+ cells and CFU measured in the apheresis product (r = 0.49, P = .003). The first transplant regimen given to 38 patients consisted of thiotepa, carboplatin, and cyclophosphamide. The second transplant regimen given to 29 patients consisted of busulfan and etoposide. Hematologic recovery was comparable after each of the two transplant courses. The median time to neutrophil recovery over 0.5 x 10(9)/L and to platelet transfusion independence was 9 and 8 days, respectively. There was no difference in engraftment rates after transplant with PBPC only (n = 28 courses) compared to transplant with PBPC plus bone marrow (n = 39 courses).(ABSTRACT TRUNCATED AT 250 WORDS)
Asunto(s)
Trasplante de Células Madre Hematopoyéticas , Neoplasias/terapia , Antígenos CD/análisis , Antígenos CD34 , Separación Celular/métodos , Femenino , Trasplante de Células Madre Hematopoyéticas/efectos adversos , HumanosAsunto(s)
Enfermedades del Sistema Nervioso/terapia , Intercambio Plasmático , Antipsicóticos/uso terapéutico , Enfermedades Autoinmunes/tratamiento farmacológico , Enfermedades Autoinmunes/terapia , Terapia Combinada , Humanos , Inmunosupresores/uso terapéutico , Enfermedades del Sistema Nervioso/tratamiento farmacológico , Enfermedades Neuromusculares/terapia , Síndromes Paraneoplásicos/terapia , Trastornos Psicóticos/tratamiento farmacológico , Trastornos Psicóticos/terapiaAsunto(s)
Enfermedades Autoinmunes/terapia , Eliminación de Componentes Sanguíneos , Intercambio Plasmático , Enfermedades Autoinmunes/complicaciones , Enfermedades Autoinmunes/tratamiento farmacológico , Terapia Combinada , Infecciones por VIH/complicaciones , Humanos , Inmunosupresores/uso terapéuticoAsunto(s)
Enfermedades Renales/terapia , Intercambio Plasmático , Crioglobulinemia/complicaciones , Crioglobulinemia/terapia , Rechazo de Injerto/terapia , Humanos , Enfermedades Renales/etiología , Trasplante de Riñón , Mieloma Múltiple/complicaciones , Fotoféresis , Púrpura Trombocitopénica Trombótica/terapiaRESUMEN
Therapeutic apheresis is a generic term that refers to removal of abnormal blood cells and plasma constituents. The terms "plasmapheresis," "leukapheresis," and "erythrocytapheresis" describe the specific blood element that is removed. Apheresis therapies can be performed in the ICU to manage a number of neurologic, hematologic, and autoimmune disorders, including myasthenia gravis, Guillain-Barré syndrome, sickle-cell disease, and Goodpasture's syndrome. Apheresis procedures generally require two points of contact with the circulation--one for blood withdrawal and one for return; the withdrawal site should sustain a flow rate of at least 50 mL/min. Although apheresis is generally quite safe, hemodynamic instability, hypocalcemia, and dilutional coagulopathy can occur.
Asunto(s)
Eliminación de Componentes Sanguíneos/métodos , Enfermedades Autoinmunes/terapia , Eliminación de Componentes Sanguíneos/efectos adversos , Eliminación de Componentes Sanguíneos/instrumentación , Contraindicaciones , Enfermedades Hematológicas/terapia , Humanos , Enfermedades del Sistema Nervioso/terapiaRESUMEN
A group of modifications, including a reservoir bag in the return circuit, has been devised to allow single needle plateletpheresis with the COBE Spectra. We compared the number and quality of platelets collected from 10 subjects in paired donations with single and dual needle protocols. There was no evidence of hemolysis with either protocol. Mean (+/- SD) platelet yields were 3.61 +/- 1.47 x 10(11) with two needles and 3.31 +/- 1.31 x 10(11) with the single needle procedure (P = .13). Mean leukocyte levels (standard manual counting chamber) were 1.0 +/- 1.7 x 10(7) and 1.2 +/- 1.0 x 10(7), respectively (p = .78). pH values during storage were acceptable in both groups of concentrates, and there were no significant differences between the single needle and dual needle concentrates in morphology scores or beta-thromboglobulin levels at 0, 1, 3, or 5 days of storage. Thus the single needle modification produced platelets that were comparable in quantity and quality to those from the standard dual needle plateletpheresis protocol.