Objective/purpose The primary purpose of this study was to compare three closed-system transfer devices with differing mechanical interfaces for their suitability for adoption into our daily practice. The secondary purpose was to use the results of this study to support the selection of one of the closed-system transfer devices, which would suit both the pharmacy and nursing staff at our institution, furthermore promoting the enculturation of international recommendations into our clinical practice. Study design/methods The hazardous drug preparation process was observed and timed continuously from the moment the technician started compounding until the finished product was handed to the designated checker by raising hands. A self-administered, structured questionnaire was used for data collection looking at ease of use of each of the devices from the perspective of pharmacy technicians and nurses. The questionnaire contained an open-ended 10-point Likert-type scale of eight domains. Results/key findings An improvement in the compounding efficiency of hazardous drugs using PhaSeal™ ( n = 46), ChemoLock™ ( n = 45), and EquaShield® II ( n = 45), when compared respectively against the historical control ( n = 86), was statistically significant ( p < 0.001). However, no statistically significant difference among the different closed-system transfer devices for preparation of hazardous drugs was observed in our study ( p = 0.1). In terms of ease of use, there was no difference in preference for ChemoLock™ and Equashield®II among the pharmacy technicians with both scoring a mean score of 10 with regard to implementation. While PhaSeal™ scored a mean score of 7.2. Among the nursing staff there was a slight preference for ChemoLock™ over Equashield®II with a mean score of 9.2 and 9, respectively with regard to the recommended product, while PhaSeal™ scored a mean score of 7.4. Both nursing staff and pharmacy technicians had a preference ChemoLock™, with a mean score of 10 and 9.6, respectively in terms of on how easy was each device/system to use and overall impression for pharmacy technicians. This was followed by Equashield®II with a mean score of 9.8 and 8.6, respectively and then PhaSeal™ with a mean score of 7.2 and 6.6, respectively. Pharmacy technicians felt there were more steps, packaging and clutter when using PhaSeal® in comparison to the other devices. With Equashield® II, the estimation of clutter was higher than that of ChemoLock™ despite the number of packages being within a similar range. Conclusion/recommendations Our study found that with experienced staff, compounding of hazardous drugs with closed-system transfer devices can be as efficient as or even more so than with the traditional needle and syringe method. With the lack of statistically significant difference among the different closed-system transfer devices studied, in addition to the cost, ease of use was one of the factors that decided the products applicability in our institution.
Background: Thrombocytopenia remains a life-threatening late complication of HCT with an incidence of 5–20%. Currently, there is no approved drug for the treatment of persistent thrombocytopenia post HCT and platelet transfusion is the maintain stay of treatment. Eltrombopag is approved for the treatment of thrombocytopenia associated with different diseases, however; data on eltrombopag treatment post HCT are limited. Methods: This is a retrospective cohort study evaluating the effect of eltrombopag on platelet recovery in patients with persistent thrombocytopenia post HCT. The primary endpoint was platelet recovery to ≥ 20,000/μL for 7 consecutive days without transfusion support after starting eltrombopag. Secondary endpoint was platelet recovery to ≥ 50,000/μL for 7 consecutive days. Results: Twenty-one patients were included. Twelve (75%) of 16 patients became independent from platelet transfusions. Median time from starting eltrombopag to last transfusion was 60 days (range, 9–226 days). Ten (63%) of 16 transfusion dependent patients with platelet count < 20,000/μL achieved the primary endpoint. Seven (33%) patients of 21 included had successful platelet recovery (ie, ≥50,000/μL without transfusion support) and the median time to platelet recovery in patients who achieved it was 32 days (range, 13–265 days). Ten patients (48%) were able to successfully discontinue eltrombopag without recurrence of thrombocytopenia. Conclusion: Our findings demonstrated that eltrombopag appears to have a clinically significant impact on platelet recovery in persistent thrombocytopenic patients post HCT.
Lenalidomide is a second-generation immunomodulatory agent and a potent analogue of thalidomide that is FDA approved mainly for the treatment of multiple myeloma (MM) and transfusion-dependent anaemia due to low or intermediate-1-risk myelodysplastic syndromes (MDS) associated with 5q deletion among other indications. Through its action on the immune system, lenalidomide alters the production of different cytokines ultimately resulting in immune activation against tumours. This immune activation may lead to collateral immune toxicities like fever, angioedema, Stevens-Johnson syndrome, tumour flare and others. Here we report a case of lenalidomide-induced high grade fever in a patient with MM and we summarize the literature about the physiology of such reaction and how to mitigate this adverse event.
Introduction:Acute kidney injury (AKI) and chronic kidney disease (CKD) affect 10-70% of transplant recipients. Onset of kidney injury varies from days to months or years after transplantation. Kidney injury may be caused by multiple factors. Long-term data on cyclosporine induced nephrotoxicity post HSCT are limited. It is unclear if cyclosporine induced nephrotoxicity at early phase post HSCT will impact long term renal function. The objective of this study is to evaluate the progression of renal function in allogeneic hematopoietic stem cell transplant (HSCT) patients, before, during and after cyclosporine therapy. Methods:This is a retrospective single arm cohort study evaluating the impact of cyclosporine on renal function in patients who underwent allogeneic HSCT from 2003 through 2013. Patients age≥ 14 years who underwent allogeneic HSCT and received cyclosporine as graft-versus-host disease (GVHD) prophylaxis and alive two years post HSCT without disease relapse or GVHD were included in the study. Primary outcome was the change in serum creatinine and estimated creatinine clearance. Delta creatinine (baseline creatinine - creatinine on day 25, day 100, day 180, year 1 and year 2 post HSCT) was used to calculate the change in the serum creatinine and estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft and Gault formula (CG) for patients aged ≥ 18 years. Schwartz formula was used to estimate creatinine clearance for patients aged ≥ 14 years till 18 years. The secondary outcome was the incidence of acute kidney injury. AKI was defined as per RIFLE criteria. The severity grades were defined on the basis of the changes in serum creatinine. CKD was defined if estimated glomerular filtration rate (GFR) <60 ml/minute per 1.73 m2 for 3 months. All patient during the study period were screened. Descriptive statistics were used to describe the data, continuous variables were reported as mean ± stander deviation and categorical variables were summarized as frequencies and percentages. The study was approved by the Office of Research Affairs in our institution. Results: Out of 912 patients who underwent allogeneic HSCT from 2003 to 2013, 121 patients were included who met the inclusion criteria listed above in the method section (Figure 1). The majority of patients were males (55%) with sever aplastic anemia as primary disease (31%). Mean baseline serum creatinine was 52±16 µmol/l, mean baseline estimated creatinine clearance was 116±58 ml/minute per 1.73 m2 (Table 1). Mean duration of cyclosporine levels monitoring was 232±180 days. Serum creatinine increased from the baseline at day 25, day 100, day 180, 1 year and 2 years post HSCT (Mean± SD; 45.7 ±39, 66.2 ±45.9, 37.8±27.1, 31.9±22.55, 28±22.5 µmol/l, respectively) (Figure 2). This translated into reductions in the estimated creatinine clearance at day 25, day 100, day 180, 1 year and 2 years post HSCT (Mean± SD; -61.6±51 , -89.6 ±55.7,-67. ±55.34,-62.5±55.4,-57.6±56.ml/minute per 1.73 m2, respectively) (Figure 3). The highest incidence of AKI was at day 100 post HSCT in the included patients. 40% of them had supratherapeutic cyclosporine levels. There was association between developing acute kidney injury at day 100 and CKD at 2 years post HSCT, 23% of the included patients had acute kidney injury and 13 % of them found to have CKD at 2 years post HSCT as illustrated table 2. Conclusion:Our study demonstrated that cyclosporine represents a primary risk factor for progression of renal impairment in hematopoietic stem cell transplant recipients particularly in those who developed acute kindly injury at 100 days. Disclosures No relevant conflicts of interest to declare.
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