Faculty Opinions recommendation of Validation of a predictive model for identifying an increased risk for thromboembolism in children with acute lymphoblastic leukemia: results of a multicenter cohort study.

Author(s):  
Neyssa Marina ◽  
Maureen O'Brien
BMC Cancer ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Juan Carlos Núñez-Enríquez ◽  
Ana Elena Gil-Hernández ◽  
Elva Jiménez-Hernández ◽  
Arturo Fajardo-Gutiérrez ◽  
Aurora Medina-Sansón ◽  
...  

Blood ◽  
2010 ◽  
Vol 115 (24) ◽  
pp. 4999-5004 ◽  
Author(s):  
Lesley Mitchell ◽  
Moritz Lambers ◽  
Silke Flege ◽  
Gili Kenet ◽  
Valerie Li-Thiao-Te ◽  
...  

Abstract Among risk factors for developing thromboembolism (VTE) in children with acute lymphoblastic leukemia were Escherichia coli asparaginase, concomitant steroid use, presence of central venous lines, and thrombophilic abnormalities. Developing a predictive model for determining children at increased risk would be beneficial in targeting interventional studies to high-risk groups (HRGs). Predictive variables were incorporated into a risk assessment model, which was evaluated in 456 children and then validated in 339 patients. VTE risk by score was no greater than 2.5 for low-risk group (LRG) and greater than 2.5 for HRG. VTE rates at 3.5 months (validation cohorts) were 2.5% in LRG and 64.7% in HRG. In multivariate analysis adjusted for age, duration of asparaginase administration, enoxaparin prophylaxis, and T-immunophenotype, the HRG was significantly associated with VTE compared with the LRG (hazard/95% confidence interval [CI], 8.22/1.85-36.53). Model specificity was 96.2% and sensitivity was 63.2%. As secondary objective we investigated the use of enoxaparin for VTE prophylaxis in the HRG. HRG patients without enoxaparin prophylaxis showed a significantly reduced thrombosis-free survival compared with children on low-molecular-weight heparin (LMWH). On the basis of the high specificity, the model may identify children with leukemia at risk of VTE. LMWH may help prevent VTE in the HRG; this warrants assessment in larger cooperative clinical trials.


2018 ◽  
Vol 44 (7) ◽  
pp. 1090-1096 ◽  
Author(s):  
Vanessa Chaves Barreto Ferreira de Lima ◽  
Ana Luiza Bierrenbach ◽  
Gizelton Pereira Alencar ◽  
Ana Lucia Andrade ◽  
Luciano Cesar Pontes Azevedo

Author(s):  
Carl Mellner ◽  
Jabbar Mohammed ◽  
Magnus Larsson ◽  
Sandra Esberg ◽  
Maciej Szymanski ◽  
...  

Abstract Background The purpose of this study was to compare the cumulative incidence of postoperative periprosthetic fracture (PPF) in a cohort of femoral neck fracture (FNF) patients treated with two commonly used cemented stems: either a collarless, polished, tapered Exeter stem or the anatomic Lubinus SP2 stem. Methods In this retrospective multicenter cohort study of a consecutive series of patients, we included 2528 patients of age 60 years and above with an FNF who were treated with either hemiarthroplasty or total hip arthroplasty using either a polished tapered Exeter stem or an anatomic Lubinus SP2 stem. The incidence of PPF was assessed at a minimum of 2 years postoperatively. Results The incidence of PPF was assessed at a median follow-up of 47 months postoperatively. Thirty nine patients (1.5%) sustained a PPF at a median of 27 months (range 0–96 months) postoperatively. Two of the operatively treated fractures were Vancouver A (5%), 7 were Vancouver B1 (18%), 10 were Vancouver B2 (26%), 7 were Vancouver B3 (18%), and 13 were Vancouver C (32%). The cumulative incidence of PPF was 2.3% in the Exeter group compared with 0.7% in the SP2 group (p < 0.001). The HR was 5.4 (95% CI 2.4–12.5, p < 0.001), using the SP2 group as the denominator. Conclusions The Exeter stem was associated with a higher risk for PPF than the Lubinus SP2 stem. We suggest that the tapered Exeter stem should be used with caution in the treatment of FNF. Trial registration The study was registered at clinicaltrials.gov (identifier: NCT03326271).


2021 ◽  
Vol 12 ◽  
Author(s):  
Jiao Liu ◽  
Yanfei Shen ◽  
Zhenliang Wen ◽  
Qianghong Xu ◽  
Zhixiong Wu ◽  
...  

BackgroundThymosin alpha 1 (Tα1) is widely used to treat patients with COVID-19 in China; however, its efficacy remains unclear. This study aimed to explore the efficacy of Tα1 as a COVID-19 therapy.MethodsWe performed a multicenter cohort study in five tertiary hospitals in the Hubei province of China between December 2019 and March 2020. The patient non-recovery rate was used as the primary outcome.ResultsAll crude outcomes, including non-recovery rate (65/306 vs. 290/1,976, p = 0.003), in-hospital mortality rate (62/306 vs. 271/1,976, p = 0.003), intubation rate (31/306 vs. 106/1,976, p = 0.001), acute respiratory distress syndrome (ARDS) incidence (104/306 vs. 499/1,976, p = 0.001), acute kidney injury (AKI) incidence (26/306 vs. 66/1,976, p &lt; 0.001), and length of intensive care unit (ICU) stay (14.9 ± 12.7 vs. 8.7 ± 8.2 days, p &lt; 0.001), were significantly higher in the Tα1 treatment group. After adjusting for confounding factors, Tα1 use was found to be significantly associated with a higher non-recovery rate than non-Tα1 use (OR 1.5, 95% CI 1.1–2.1, p = 0.028). An increased risk of non-recovery rate associated with Tα1 use was observed in the patient subgroups with maximum sequential organ failure assessment (SOFA) scores ≥2 (OR 2.0, 95%CI 1.4–2.9, p = 0.024), a record of ICU admission (OR 5.4, 95%CI 2.1–14.0, p &lt; 0.001), and lower PaO2/FiO2 values (OR 1.9, 95%CI 1.1–3.4, p = 0.046). Furthermore, later initiation of Tα1 use was associated with a higher non-recovery rate.ConclusionTα1 use in COVID-19 patients was associated with an increased non-recovery rate, especially in those with greater disease severity.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 524-524
Author(s):  
Silke Flege ◽  
Lesley Mitchell ◽  
Gili Kenet ◽  
Christine Heller ◽  
Michael Fruhwald ◽  
...  

Abstract Children with acute lymphoblastic leukemia (ALL) are at increased risk for venous thromboembolism (VTE), however, not all children experience a VTE. Developing a predictive model for determining children at increased risk would be beneficial in targeting interventional studies to only high risk groups. A recent meta-analysis of studies in VTE in children with ALL identified four potential risk factors: treatment with Escherichia coli asparaginase (CASP), concomitant use of steroids, presence of central venous lines and thrombophilic genetic abnormalities. As VTE in childhood ALL is well recognized as serious clinical problem and due to the lack of studies on prevention, the standard of practice varies and some centres use enoxaparin prophylaxis for these children. However, the risks and benefits of the intervention are unknown. The aim of the study was to develop a simple model for predicting ALL-chemotherapy-associated VTE using baseline clinical and laboratory variables, and to evaluate, on an explorative basis, the increasing off-label use of enoxaparin for VTE prophylaxis in ALL children. For development of the risk model the predictive variables were scored as follows: treatment with CASP (5000–10000/m2) in combination with prednisone or dexamethasone, presence of central venous lines, thrombophilic genetic abnormalities, e.g. positive family history for VTE or identification of a single thrombophilic trait (1 point each), or carrier status of combined thrombophilic traits (2 points). A definition of VTE risk by score was low (1–2) and high (□ 3). The risk score was than prospectively validated in an independent cohort of 136 newly recruited patients enrolled into the German database. Seven patients were excluded (lost to follow-up n=2; death n=2, secondary malignancy, VTE before ALL-onset, infant &lt; 12 months of age: each n=1). The cumulative VTE rates at 3.5 months in the validation cohorts were 3.6% (95% CI 1%–9%) in the low-risk group (4 of 112), and 47% (95%CI 23%–72%) in the high-risk category (8 of 17). In multivariate analysis [Cox regression] the high risk group was significantly associated with VTE when compared to the low risk group even after adjusting for age at ALL-onset, duration of CASP administration, steroid administered (prednisone/dexamethasone), and presence or absence of enoxaparin prophylaxis [hazard/95%CI: 4.16/1.13–15.34]. The negative predictive value for VTE was 96.3% [95%CI: 92.9–99.8]. Early enoxaparin prophylaxis reduced the absolute VTE-risk about 60% [95%CI: 23–96]. Therefore, the model can identify ALL-children with an increased risk for symptomatic VTE.


Sign in / Sign up

Export Citation Format

Share Document