Abstract 3729: Delayed Hematoma Expansion Occurs After ICH: Observations from the Safety of Pioglitazone for Hematoma Resolution in INtraCerebral Hemorrhage (SHRINC) trial

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Navdeep S Sangha ◽  
Farhaan Vahidy ◽  
Mallikarjunarao Kasam ◽  
Mohammed Rahbar ◽  
Bursaw Andrew ◽  
...  

Background and Purpose Early hematoma expansion (EHE) has been described in the first 48 hours. SHRINC is a phase 2 prospective safety trial whose primary objective is to assess the safety of pioglitazone (PIO) when administered to patients with spontaneous intracerebral hemorrhage (SICH) compared to standard care. A secondary objective is to characterize the changes in hematoma resolution and expansion over time. This prospective study addresses the natural history, clinical impact, and associated risk factors of late hematoma expansion (LEX) by serial magnetic resonance imaging (MRI) after SICH. Methods SHRINC aims to enroll 78 subjects between the ages of 18-80 with a SICH of ≥ 5 ml. This analysis includes the first 42 patients enrolled. Four subjects were excluded because they did not have an MRI after day 2. A baseline CTH was performed followed by an MRI within 24 hours of symptom onset. Hematoma volume (Hv) was measured on FLAIR sequences using a previously published semi-automated range of interest method. LEX was defined as an increase in Hv > 0.5 ml after the 48 hour MRI. Factors associated with LEX were evaluated with logistic regression. Longitudinal analyses were used for measurements taken over the follow up period. Results: Ten (26.3%) of 38 subjects displayed LEX. Eight subjects had LEX between day 2 to 14, and 4 between days 14 to 28. The median initial Hv was 16.1cc in LEX patients and 24.1cc in those without expansion (NEX) (p=0.23). Lower platelet counts (p=0.04) and BUN levels (p=0.03) were associated with LEX in univariate analysis. Multivariate analysis suggested that those with higher BUN levels were less likely to have LEX (OR=0.81; 95%CI 0.65-0.99). Blood pressure and EHE (13.2%) were not associated with LEX. There was no difference in neurological worsening (NIHSS increase ≥ 4), 6 month mRS or death between LEX and NEX. Conclusion: This is the first prospective study to address LEX with serial MRIs. LEX occurs between day 2 to 14 and day 14 to 28. Elevated BUN levels may decrease the likelihood of LEX. A limitation of our study is that the effect of PIO on LEX could not be evaluated because SHRINC is a blinded trial. Further studies will assess the pathophysiology of LEX and its potential implications in clinical trials evaluating hematoma growth and resolution.

2022 ◽  
pp. 174749302110686
Author(s):  
Andrea Morotti ◽  
Gregoire Boulouis ◽  
Andreas Charidimou ◽  
Loris Poli ◽  
Paolo Costa ◽  
...  

Background: Hematoma expansion (HE) is common and associated with poor outcome in intracerebral hemorrhage (ICH) with unclear symptom onset (USO). Aims: We tested the association between non-contrast computed tomography (NCCT) markers and HE in this population. Methods: Retrospective analysis of patients with primary spontaneous ICH admitted at five centers in the United States and Italy. Baseline NCCT was analyzed for presence of the following markers: intrahematoma hypodensities, heterogeneous density, blend sign, and irregular shape. Variables associated with HE (hematoma growth > 6 mL and/or > 33% from baseline to follow-up imaging) were explored with multivariable logistic regression. Results: Of 2074 patients screened, we included 646 subjects (median age = 75, 53.9% males), of whom 178 (27.6%) had HE. Hypodensities (odds ratio (OR) = 2.67, 95% confidence interval (CI) = 1.79–3.98), heterogeneous density (OR = 2.16, 95% CI = 1.46–3.21), blend sign (OR = 2.28, 95% CI = 1.38–3.75) and irregular shape (OR = 1.82, 95% CI = 1.21–2.75) were independently associated with a higher risk of HE, after adjustment for confounders (ICH volume, anticoagulation, and time from last seen well (LSW) to NCCT). Hypodensities had the highest sensitivity for HE (0.69), whereas blend sign was the most specific marker (0.90). All NCCT markers were more frequent in early presenters (time from LSW to NCCT ⩽ 6 h, n = 189, 29.3%), and more sensitive in this population as well (hypodensities had 0.77 sensitivity). Conclusion: NCCT markers are associated with HE in ICH with USO. These findings require prospective replication and suggest that NCCT features may help the stratification of HE in future studies on USO patients.


Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Lori C Jordan ◽  
Lauren A Beslow ◽  
Melissa C Gindville ◽  
Jonathan T Kleinman ◽  
Rachel A Bastian ◽  
...  

Objective: Hematoma expansion and its predictors like the “spot sign” are important research areas in adults with primary (hypertensive) intracerebral hemorrhage (ICH), but are rarely studied in secondary ICH. At one center, in adults with ICH due to brain arteriovenous malformation (AVM), aneurysm, or tumor, significant hematoma expansion (>33%) occurred in 6/30 (20%) within 24 hours. In children, the frequency of hematoma expansion and the appropriate timing of follow-up neuroimaging are unknown. We assessed the frequency and extent of hematoma expansion in children with non-traumatic ICH. Methods: From 2007 to 2012, 73 children with spontaneous ICH were enrolled in a three-center prospective study (≥37 weeks gestation-17 years). Inclusion for this sub-study: 2 head CTs obtained for clinical indications within 48 hours after presentation with ICH (28 children). Exclusion: Surgical evacuation of hematoma before 2 nd CT was obtained (2 children), IVH only (7 children), neonates <29 days old (20 children). Hematoma volume was assessed via manual volumetric analysis. Results: Of 73 children, 25 (34%) met all inclusion and exclusion criteria. Median age was 9.0 years, interquartile range (IQR) 2.1-14.1. Median time from symptom onset to first CT was 9.4 hours (IQR 4.5-20). ICH was due to coagulopathy or vascular cause in 22/25 children (88%). Median baseline ICH volume was 22.2mL (range 2-86mL). Hematoma expansion occurred in 7/25 (28%) with 2 head CTs. Median ICH volume expansion was 4mL (range 0.1-12mL), 32% (range 2-58%) of baseline ICH volume. Three had significant (>33%) expansion; all had coagulopathy or vascular etiologies of ICH. As expected, children with 2 head CTs had larger baseline ICH volumes (p=0.05) and were more likely to receive treatment for elevated intracranial pressure (ICP) (p=0.001) compared to children with ICH who had fewer than 2 head CTs within 48 hours. Conclusion: Hematoma expansion occurred in 28% of children with clinical concern for hematoma growth and was >33% in 12%. Repeat CT should be considered in those with large ICH and increased ICP. Head CTs were not obtained at prescribed time intervals; research CTs without clear benefit are not feasible in children.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Joan Martí-Fàbregas ◽  
Estrella Morenas ◽  
Raquel Delgado-Mederos ◽  
Lavinia Dinia ◽  
Esther Granell ◽  
...  

Introduction Microhemorrhages (MH) are lesions detected on radiological studies resulting from an underlying small-vessel angiopathy. We assesed the hypothesis that the presence of MH increases the risk of hematoma growth (HG) in patients with acute Intracerebral Hemorrhage (ICH). Methods We evaluated a series of patients in a prospective and multicentre study. We included patients with a spontaneous supratentorial ICH within the first 6 hours after symptom onset, that also had a follow-up CT 24-72 hours later and a MRI performed after a variable time after ICH. HG was defined as an increase >33% in the volume of hematoma on the follow-up CT, in comparison with the admission CT. The volume was calculated using the formula AxBxC/2. On MR scans we assessed the presence, number and distribution of MH. After differential diagnosis with other radiological lesions, MH were evaluated on echo-gradient sequences and defined as hypointense rounded lesions with a diameter <10mm. Statistical analysis: Bivariate tests with the whole sample and with the subgroup of patients with less than 3 hours from symptom onset. Results We studied 46 patients, whose mean age was 68.8±11.2 y and 68% were men. Mean baseline volume was 19.1±27.3 cc. We detected MH in 7/15 patients with HG and in 18/31 patients without HG (46.7% vs 58.1%, p=0.53). In the subgroup of patients with 10 MH, the risk of HG was higher than in patients with 0-10 MH (75% vs 28.6%, p=0.067), and this difference was significant when considering only patients with a <3 hours evolution (100% vs 31%, p=0.044). We did not observe any association between risk of HG and distribution of MH. Age and time to CT were equivalent in the two groups (with and without HG), either in the <6 or <3 hours subgroups. Conclusions In conclusion, in patients with hyperacute ICH, the presence of more than 10 MH increases the risk of HG. This is probably an indirect marker of a more severe underlying angiopathy.


Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Shahram Majidi ◽  
Basit Rahim ◽  
Sarwat I Gilani ◽  
Waqas I Gilani ◽  
Malik M Adil ◽  
...  

Background: The temporal evolution of intracerebral hematomas and perihematoma edema in the ultra-early period on computed tomographic (CT) scans in patients with intracerebral hemorrhage (ICH) is not well understood. We aimed to investigate hematoma and perihematoma changes in “neutral brain” models of ICH. Methods: One human and 6 goat cadaveric heads were used as “neutral brains” to provide physical properties of the brain without any biological activity or new bleeding. ICH was induced by slow injection of 4 ml of fresh blood into the right basal ganglia of the goat brains. Similarly, 20 ml of fresh blood was injected deep into the white matter of the human cadaver head in each hemisphere. Serial CT scans of the heads were performed at 0, 1, 3, and 5 hours after inducing ICH. Analyze software (AnalyzeDirect, Overland Park, KS) was used to measure hematoma and perihematoma hypodensity volumes in the baseline and follow up CT scans. Results: The initial hematoma volumes of 11.6 ml and 10.5 ml in the right and the left hemispheres of the human cadaver brain gradually decreased to 6.6 ml and 5.4 ml at 5 hours, showing 43% and 48% retraction of hematoma, respectively. The volume of the perihematoma hypodensity in the right and left hemisphere increased from 2.6 ml and 2.2 ml in the 1 hour follow up CT scans to 4.9 ml and 4.4 ml in the 5 hour CT scan, respectively. Hematoma retraction was also observed in all six ICH models in the goat brains. The mean ICH volume in the goat heads was decreased from 1.49 ml in the baseline CT scan to 1.01 ml in the 5 hour follow up CT scan showing 29.6% hematoma retraction. Perihematoma hypodensity was visualized in 70% of ICH in goat brains, with an increasing mean hypodensity volume of 0.4 ml in the baseline CT scan to 0.8 ml in the 5 hour follow up CT scan. Conclusion: Our study demonstrated that substantial hematoma retraction and perihematoma hypodensity occurs in intracerebral hematomas in the absence of any new bleeding or biological activity of the surrounding brain. Such observations suggest that active bleeding is underestimated in patients with no or small hematoma expansion and our understanding of perihematoma hypodesity needs to be reconsidered.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 534-534 ◽  
Author(s):  
Seema Ahsan Khan ◽  
Constantine Gatsonis ◽  
Brad Snyder ◽  
Constance D Lehman ◽  
Joseph A. Sparano ◽  
...  

534 Background: Prior retrospective studies have evaluated breast MRI in DCIS, and prospective-retrospective biomarker studies have shown that the DCIS Score is prognostic for recurrence after BCS alone. E4112 is a prospective cohort study designed to assess the combined impact of breast MRI and DCIS Score on surgical and RT management. Methods: Women diagnosed with screen-detected DCIS on core biopsy, if BCS eligible, underwent breast MRI. Those remaining so following MRI and related biopsies, with no invasive disease, underwent BCS. If final surgical margins were ≥2 mm, the DCIS lesion was submitted for DCIS Score assay. Women with low DCIS Score (≤39, LS) were advised that RT could be avoided; RT was recommended to those with high/intermediate (H/I) scores. The primary objective was to estimate the fraction converting to mastectomy (Mx) following MRI. Secondary objectives included estimation of re-operation rates after first BCS, and DCIS Score distribution.A sample size of 333 evaluable women would allow estimation of Mx rate of 12% with 95% confidence interval 9-16%. Results: 334 enrolled women had completed surgery; the first surgical procedure was Mx in 54 (16.2%) and BCS in 280 (83.8%), of whom 62 (22.1%) required at least one re-excision, and 11 (3.9%) converted to Mx. DCIS Scores were obtained on 171 patients who completed BCS, of whom 82 were LS and 89 were H/I. Demographics were similar between the two groups, other features will be reported. Only 7/82 (8.5%) of the LS group received RT, whereas 82/89 (92.1%) of the H/I group received RT. Of the 98 BCS patients who did not qualify for DCIS Score-based therapy, 23 had invasive disease, 34 had final surgical margins < 2 mm, and 13 had both. There was insufficient tissue for DCIS Score in 11, and 17 did not complete follow-up. Conclusions: In this study, among DCIS patients who were BCS-eligible following MRI, total mastectomy rate was 19.5%; re-excision rate was 22.1% for women who had BCS. Approximately half had low DCIS Scores, and RT recommendations based on the DCIS Score were acceptable to most women. Clinical trial information: E4112.


Breast Care ◽  
2017 ◽  
Vol 12 (4) ◽  
pp. 255-259 ◽  
Author(s):  
Mohammed Osman ◽  
Mohammad Elkady

Background: The primary objective of the study was to evaluate the long-term changes in ejection fraction (EF) associated with paclitaxel infusion. Methods: 50 patients were enrolled in this prospective study between 2011 and 2015. The study design included frequent follow-up visits to the clinic, EF evaluation at baseline, and regular EF assessment by echocardiography for 30 months after treatment. Results: The median baseline EF was 60% (95% confidence interval (CI) 50-80%). At 30 months, the median EF was 48% (95% CI 40-60%; p = 0.03). During the 30-month follow-up, 10 (20%) patients developed grade 1 and 2 cardiotoxicities; none developed grade 3 or 4 cardiotoxicities. Furthermore, paclitaxel cardiotoxicity increased among patients with high-risk features including associated diabetes mellitus, hypertension, prior radiotherapy to the chest wall, performance status of 2, and age > 60 years. Conclusion: Paclitaxel has cardiotoxic effects. Careful monitoring of cardiac function during and after paclitaxel infusion is required in patients with high-risk features.


2021 ◽  
Vol 8 ◽  
Author(s):  
Bo Wang ◽  
Anhua Huang ◽  
Min Jiang ◽  
Haidong Li ◽  
Wenqing Bao ◽  
...  

Objective: For patients with gallstones, laparoscopy combined with choledochoscopic lithotomy is a therapeutic surgical option for preservation rather than the removal of the gallbladder. However, postoperative recurrence of gallstones is a key concern for both patients and surgeons. This prospective study was performed to investigate the risk factors for early postoperative recurrence of gallstones.Methods: The clinical data of 466 patients were collected. Each patient was followed up for up to 2 years. The first follow-up visit occurred 4 months after the operation, and a follow-up visit was carried out every 6 months thereafter. The main goal of each visit was to confirm the presence or absence of gallbladder stones. The factors associated with gallstone recurrence were analyzed by univariate analysis and Cox regression.Results: In total, 466 eligible patients were included in the study, and 438 patients (180 men and 258 women) completed the 2-year postoperative follow-up. The follow-up rate was 94.0%. Recurrence of gallstones was detected in 5.71% (25/438) of the patients. Univariate analysis revealed five risk factors for the recurrence of gallstones. Multivariate Cox regression analysis showed that multiple gallstones, a gallbladder wall thickness of ≥4 mm, and a family history of gallbladder stones were the three predictive factors for postoperative recurrence of gallstones (P &lt; 0.05).Conclusion: The overall 2-year recurrence rate of gallstones after the operation was 5.71%. Multiple gallstones, a gallbladder wall thickness of ≥4 mm, and a family history of gallstones were the three risk factors associated with early postoperative recurrence of gallstones.


Children ◽  
2021 ◽  
Vol 8 (9) ◽  
pp. 800
Author(s):  
Pilar Alfageme-García ◽  
Julián Fernando Calderón-García ◽  
Alfonso Martínez-Nova ◽  
Sonia Hidalgo-Ruiz ◽  
Belinda Basilio-Fernández ◽  
...  

Background: Schoolchildren often spend a lot of time carrying a backpack with school equipment, which can be very heavy. The impact a backpack may have on the pronated feet of schoolchildren is unknown. Aims: The objective of this study was to evaluate the association of the backpack use on static foot posture in schoolchildren with a pronated foot posture over 36 months of follow-up. Methods: This observational longitudinal prospective study was based on a cohort of consecutive healthy schoolchildren with pronated feet from fifteen different schools in Plasencia (Spain). The following parameters were collected and measured in all children included in the study: sex, age, height, weight, body mass index, metatarsal formula, foot shape, type of shoes, and type of schoolbag (non-backpack and backpack). Static foot posture was determined by the mean of the foot posture index (FPI). The FPI was assessed again after 36 months. Results: A total of 112 participants used a backpack when going to school. Over the 36-month follow-up period, 76 schoolchildren who had a static pronated foot posture evolve a neutral foot posture. Univariate analysis showed that the schoolchildren using backpacks were at a greater risk of not developing neutral foot (odds ratio [OR]: 2.09; 95% CI: 1.08–4.09). The multivariate analysis provided similar results, where the schoolchildren using a backpack (adjusted OR [aOR]: 1.94; 95% CI: 1.02–3.82) had a significantly greater risk of not developing a neutral foot posture. Conclusions: A weak relationship was found between backpack use and schoolchildren aged from five to eleven years with static pronated feet not developing a neutral foot posture over a follow-up period of 36 months.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10120-10120
Author(s):  
Reza Elaidi ◽  
Stephane Oudard ◽  
Hail Aboudagga ◽  
Constance Thibault ◽  
Lorraine Waechter ◽  
...  

10120 Background: The PROCHE [Programme for optimisation of the chemotherapy network] initiative is an innovative oncology-monitoring program designed to reduce patient waiting time and chemotherapy wastage, ultimately improving patient care. Methods: Primary objective was to evaluate the incidence of nausea reported by grade (NCI-CTC AE: from 0 to 4) from 2008 to 2016. Association was quantified using Mantel-Haenszel khi2 and exact p-values. Secondary objective compared the 2009-2016 patients with the control patients of 2008 period. Results: Between Oct 2008 and Oct 2016, 3012 patients participated in the program, representing 36 803 questionnaires completed over the whole period. Nausea was, clinically and statistically, significantly improved during the whole follow-up period with a decrease of grade 3-4 from 0.6% to 0.08% and a decrease of grade 1-2 from 29.3% to 8.2%. The already adapted nausea management in 2008 with 70% of questionnaires reported no nausea improved to 92% in 2016, with a 10% improvement the year after program initiation. As MASCC propose to change guidelines with an improvement above 10%, such an organization may impact new recommendations. Conclusions: Anticipating anti-cancer treatment adaptation and prevention, following guidelines and using adapted antiemetics, explain these positive results. The PROCHE initiative improves chemotherapy induced nausea. [Table: see text]


Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Xiaoying Yao ◽  
Magdy Selim ◽  
Ye Xu ◽  
Erica Siwila-Sackman

Background: Early identification of intracerebral hemorrhage (ICH) patients at risk of significant hematoma expansion (SHE) could facilitate the selection of appropriate patients who are likely to benefit from therapies aiming to minimize ICH growth. Nomograms have been proved to have superior individualized disease-related risk estimations of given outcomes. This study aims to develop a normogram that can be performed during the hyperacute phase to predict the risk of SHE in patients with spontaneous ICH. Methods: We reviewed clinical, laboratory, and radiological data from 237 patients diagnosed with spontaneous ICH who had baseline head CT within 12 hours of symptom onset and follow-up CT during the following 72 hours. SHE was defined as an absolute increase in ICH volume > 6ml or an increase greater than 33% from baseline to follow-up CT. To construct the nomogram, we performed logistic regression analyses to determine the predictors of SHE. Each predictor was assigned a point in the graphic interface of a nomogram, and the points were summed up to determine the predicted probability of SHE for a specific ICH patient. Results: SHE occurred in 74 patients (31.2%). The final model to predict SHE, presented as a nomogram, included: time from onset to baseline CT scan (< 3h vs 3-12h), dementia, current smoking, antiplatelet use, serum creatinine level, Glasgow Comma Scale score, and presence of subarachnoid hemorrhage on baseline CT. The model had satisfactory discrimination ability with a bootstrap corrected c index of 0.77 (95% CI, 0.75-0.82) and good calibration. The in-hospital mortality was higher in patients with SHE (42% vs. 15%; p <0.001). Conclusion: We developed and internally validated a novel nomogram model which accurately predicts the possibility of SHE based on seven easily obtainable parameters. This could be useful for treatment decision and stratification. External validation of our nomogram is warranted before its application to other populations.


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