he Blood Products Advisory Committee of the Food and Drug Administration (FDA) recently recommended the approval of the use of solvent T and detergent treatment for fresh-frozen plasma (FFP). The FDA is expected to issue soon a license to VI.Technologies, Inc. (VITEX, New York, NY) to produce solventldetergent (SD)-treated plasma (SD plasma). Because an estimated 2 million units of plasma are transfused in the United States each year, the availability of an alternative blood component will likely have a significant impact on physician practices and on the supply of, and demand for, FFP This report reviews issues surrounding the development of SD technologies for use in virus inactivation, current clinical data relevant to the use of SD plasma, and answers to some commonly asked questions. The review is intended not to establish a standard or requirement for the use of FFP or SD plasma, but to provide background information for medical staffs as they consider transfusion alternatives. Development of guidelines or standards for voluntary compliance will require additional clinical data.Currently, most FFP is prepared in blood centers as a by-product of whole-blood processing, although FFP can also be prepared by plasmapheresis. FFP is a relatively safe biologic; its overall risk is estimated at 7.5 adverse events per 10,000 units transfused and 3.7 adverse events per 1,000 ABBREVIATIONS: AHF = anti-hemophilic factor; FDA = Food and Drug Administration; FFP = fresh-frozen plasma; HAV = hepatitis A virus; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; IU = International units; SD = solventldetergent (treatment); TNBP = tri(n-buty1)phosphate; lTP = thrombotic thrombocytopenic purpura.From the American Association of Blood Banks Ad Hoc Committee on SolventlDetergent-Treated Plasma.
Current standards for the preparation of factor VIII (FVIII) concentrates from human plasma recommend separation of plasma from red cells (RBCs) within 6 hours of blood donation, thereby reducing the volume of plasma from donated whole blood available for processing to FVIII concentrate. The decay of FVIII clotting activity (FVIII:C) in whole blood and plasma stored at 22 and 4 degrees C and the recovery of FVIII:C in cryoprecipitate and FVIII concentrate prepared from plasma separated from whole blood stored overnight at 4 degrees C were investigated. In whole blood stored at 22 degrees C and plasma stored at either 4 or 22 degrees C, 90 percent of the original FVIII:C was present at 6 hours, 80 percent at 12 hours, and 65 to 70 percent at 18 hours. At these times lower levels of FVIII:C were recovered from whole blood stored at 4 degrees C, that is, 84, 68, and 56 percent, respectively. In cryoprecipitates prepared from plasma separated from RBCs after 18 hours' storage at 4 degrees C (18-hour plasma), 43 percent of FVIII:C activity was recovered, as compared with 61 percent recovered from standard plasma separated within 6 hours of donation (6-hour plasma), p less than 0.05. With large-scale preparation of FVIII concentrates, however, the yield of FVIII:C was similar whether 18- or 6-hour plasma was used. Thus FVIII concentrates--but not cryoprecipitates--can be prepared from plasma separated from whole blood stored at 4 degrees C for up to 18 hours without undue loss of potency.
Chest physiotherapy is a frequently practiced but poorly documented form of therapy. Twenty neonates (mean age43 hr) were studied with a variety of respiratory disorders to assess the effect of complete chest physiotherapy on arterial blood cases. This was compared to the alteration of blood gases following suctioning of the airway. Nine were receivin~ added oxygen alone, six were receiving continuous distending pressure and five were intubated receiving mechanical ventilation. Complete chest physie therapy treatment consisted of postural drainage with percussions and vibrations in each drainage position followed by suctioning of the airway. The treatment was performed for a specific area of lung involvement if present. For generalized lung disorders, drainage was performed with an emphasis on the basal segments of the lower lobes. Each infant had arterial blood gases performed five minutes prior to and twenty minutes fdllowing suctioning, and similarly before and after physiotherapy (average interval between the two pairs=1.8 hr) There was a mean increase of 20.8 mm Hg in the pO following physiotherapy. (p(0.01) with no sipificant change zbserved following suctioning. There was no significant change in the pH or pCO with either procedure. Analysis of covariance revealed no signihcant correlations between p02 and sex, age, body weight, gestation, inspired oxygen concentration, or the order of receiving the procedures. In neonates with respiratory distress, oxygenation is improved following physiotherapy. VT were unchanged. Two hour followup values f o r a l l parameters studied were s i m i l a r t o control values except f o r a trend toward increased compl lance. There were no s i g n i f i c a n t d i f f e rences a t any stage o f the study f o r PaC02, pH, base excess. VT. o r minute ventilation. This studv indicates t h a t there i s a j i g n i f i c a n t de rease i n Pa02 a f t e s t v b t i o n nd suc toning n rease i n pa82 a f t e r hy erventPFa€!on but Feiese ceianges f o not appear t o be related t o ayterations i n lung volume. 190 E"%N,EBfvTef F k E E S~~a X F f l % e f R P T~i t i t u t eFACTORS AFFECTING LUNG VOLUME IN POST EXTUBATED NEONATES. William W. Fox, Jacob G. Schwartz. Thomas The Hospital for Sick Children, Toronto, Canada. It has been well established that slowly adapting vagal The failure to elicit a deflation reflex in all infants, and the absence of response to mucosal stimulation in sane infants suggasta that vagal irritant reflexes are weak or absent in human newborns. This may be one reason why aspiration is common in this age group. s~e c i a l 06biems. since neonatal CT tdbes are'uniuffed they Perm i t leakege o f gas around the tube during respiration and, therefore, introduce errors i n FRC determination. The present study evaluates a new 60 second closed c i r c u i t helium (He) d i l u t i o n technique f o r determination o f FRC independent o f small ga: leaks. By a n a l y t i c a l l y r e l a t i n q the f a l l i n lie concentration due LO mixi n g w i t h that due ...
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2025 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.