scholarly journals Spotlight on Consent:  Lessons from the SPOTLIGHT Trial for Acute Intracerebral Hemorrhage

2020 ◽  
Author(s):  
Tess Fitzpatrick ◽  
Michel Shamy ◽  
Brian Dewar ◽  
Julie Spence ◽  
Andrew M. Demchuk ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Emergency Treatment ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Treatment Options ◽  
Item Questionnaire ◽  
Acute Intracerebral Hemorrhage ◽  
Initial Survey ◽  
Trial Participants

Abstract Background SPOTLIGHT was a Canadian multicentre, placebo-controlled, randomized trial of emergency treatment with recombinant Factor VIIa for patients with acute intracerebral hemorrhage that enrolled a subset of eligible patients via deferral of consent. We investigated attitudes towards deferral of consent among participants and their legally-authorized representatives (LARs). Methods All participants or LARs approached for enrolment in SPOTLIGHT were invited to complete an 11-item questionnaire within the first 4 days of enrolment, and again at 90 days. Results Eight out of 50 participants in SPOTLIGHT (16%) were enrolled via deferral of consent. Ten LARs for participants (20%) completed the initial survey and 6 completed the 90 day follow-up survey. Ninety percent of respondents agreed with the process of deferral of consent both in principle and specifically for the SPOTLIGHT trial. Participants were more likely to support deferral of consent for low-risk or time-sensitive interventions, or in situations with no alternative treatment options. Conclusions The majority of respondents were supportive of using deferral of consent to enrol participants into SPOTLIGHT and acute stroke trials.

scholarly journals Safety and Feasibility of Recombinant Factor VIIa for Acute Intracerebral Hemorrhage

Stroke ◽  
2005 ◽  
Vol 36 (1) ◽  
pp. 74-79 ◽  
Author(s):  
Stephan A. Mayer ◽  
Nikolai C. Brun ◽  
Joseph Broderick ◽  
Stephen Davis ◽  
Michael N. Diringer ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Acute Intracerebral Hemorrhage

Abstract 2276: Microhemorrhage Burden Increases the Risk of Hematoma Growth in Patients with Intracerebral Hemorrhage

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Joan Martí-Fàbregas ◽  
Estrella Morenas ◽  
Raquel Delgado-Mederos ◽  
Lavinia Dinia ◽  
Esther Granell ◽  
...  
Keyword(s):  
Differential Diagnosis ◽  
Statistical Analysis ◽  
Intracerebral Hemorrhage ◽  
Multicentre Study ◽  
Symptom Onset ◽  
Variable Time ◽  
Hematoma Growth ◽  
Acute Intracerebral Hemorrhage ◽  
Radiological Studies

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.

Abstract TP336: Characteristics and Outcome of Patients With Acute Intracerebral Hemorrhage Who Overuse Alcohol

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Carla Avellaneda-Gómez ◽  
Maria Serra Martínez ◽  
Alejandra Gómez González ◽  
Ana Rodríguez-Campello ◽  
Angel Ois ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Alcohol Intake ◽  
Short Term ◽  
Acute Intracerebral Hemorrhage ◽  
Stroke Center ◽  
Ich Score ◽  
Heavy Alcohol Intake ◽  
Long Term Mortality

Background: Alcohol overuse (AO) is considered a cause of spontaneous intracerebral hemorrhage (ICH), but the clinical and outcome characteristics of these patients (AO+ICH) are not well known. Methods: All patients with ICH admitted from January 2005 to June 2015 to a single university tertiary stroke center were prospectively studied and followed up during 5 years. Demographic features, radiological characteristics, and clinical outcome of patients with acute ICH and previous heavy alcohol intake (>40 gr/day or >300 gr/week) were analyzed. Results: During the study period, 609 patients with ICH were admitted. Nineteen patients were excluded because data on alcohol intake was not available. At admission, 83 patients (13.6%) were identified with AO (22.7% of men vs 2.9% of women; p< 0.0001) and was more frequent in younger patients (mean age, 63.11 years, compared to 72.7 years overall; p< 0.0001). Smoking was associated with AO (63,9% vs 13,8% non-AO; p< 0.0001) but not significant differences were found according with cardiovascular risk factors (dyslipidemia, diabetes and hypertension). ICH score was lower in the AO group (1.3 vs 1.8, p= 0.009) and deep ICH were more frequent (p= 0.036), compared to non-AO. Adjusted by sex, age, and high blood pressure, a trend in favor of increased deep ICH in AO patients remained (HR: 1.68 [95% CI: 0.92-3.05], p= 0.086). Adjusted mortality at 3-month, 12-month, and 5-year follow-up was similar in both groups. Conclusions: AO was present in 13.6% of ICH patients. These patients were an average of 11.5 years younger, predominantly men, and smokers, compared to the non-AO group. Adjusted short-term and long-term mortality was similar in AO and non-AO groups.

Acquired Hemophilia: Characteristics and Treatment Outcome of a Standardized Therapeutic Approach in a Singapore Series.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4019-4019
Author(s):  
Heng J. Ng ◽  
Daryl C.L. Tan ◽  
Lai H. Lee
Keyword(s):  
Treatment Outcome ◽  
Therapeutic Approach ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Bleeding Complications ◽  
Sustained Remission ◽  
Variable Degree ◽  
Acquired Hemophilia ◽  
Treatment Complications

Abstract Introduction: Acquired hemophilia is a rare bleeding disorder with significant mortality risk but is yet highly treatable. Patients diagnosed with this condition in our institution have been treated with a standardized approach aimed at detecting and controlling bleeding early and inhibitor elimination. Objective: Review the effectiveness and treatment outcome of our therapeutic approach to acquired hemophilia patients. Methods: Consecutive patients diagnosed with acquired hemophilia over a period of 5 years from July 1998 till July 2004 were retrospectively reviewed for their underlying characteristics, responses to treatment, complications and subsequent outcome. Results: 13 patients were recorded with age ranging from 17 to 89 years (median 66 years) and a male to female ratio of 10:3. Follow-up periods range from 5 to 56 months. All patients presented with variable degree of bleeding. Four patients were given recombinant factor VIIa (from 1 to 5 doses) for the control of life threatening bleeding. Three patients received prothrombin complexes as bypassing agents. One other patient received both agents..All patients received both cyclophosphamide (50–100mg/day) and prednisolone (1 mg/kg/day) for elimination of inhibitors at diagnosis. Six patients received intravenous immunoglobulin of 1 gm/kg/day for 2 days with this decision based on the severity of bleeding. Two early deaths were recorded from retroperitoneal bleeding and cerebral infarct following recombinant factor VIIa therapy, respectively. Another death occurred following sepsis with multiple co-morbidities, while being given immunosuppressive therapy. He was the only patient experiencing significant leucopenia while on cyclophosphamide therapy. Two patients were lost to follow-up subsequently. Of 8 patients evaluable for response to inhibitor eliminating therapy with cyclophosphamide and prednisolone, all but one achieved a complete remission within 7 to 71 days with a median of 41 days. Of these 7 patients, there was one early relapse, which occurred from non-compliance to treatment while it was being tailed down. Remission was successfully reinduced on reintroduction of both cyclophophamide and prednisolone. All other patients have remained in remission after discontinuation of therapy. The patient with failure of complete response had persistent low inhibitor levels without bleeding complications and died after 56 months of follow up from unrelated causes. Overall mortality of evaluable patients was 27% (3 out of 11). Conclusion: Mortality remains significant in this condition with control of early bleeding risks and treatment complications paramount to survival. For the great majority of patients, our strategy affords effective inhibitor elimination and sustained remission of this condition

scholarly journals Early Cognitive Impairment after Intracerebral Hemorrhage in the INTERACT1 Study

2017 ◽  
Vol 44 (5-6) ◽  
pp. 320-324 ◽  
Author(s):  
Shoujiang You ◽  
Xia Wang ◽  
Richard I. Lindley ◽  
Thompson Robinson ◽  
Craig S. Anderson ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Intracerebral Hemorrhage ◽  
Mini Mental State Examination ◽  
Multivariable Analysis ◽  
The Elderly ◽  
Background Data ◽  
Acute Intracerebral Hemorrhage ◽  
State Examination ◽  
Intensive Blood Pressure

Background: Data on cognitive impairment after acute intracerebral hemorrhage (ICH) are limited. This study is aimed at determining the frequency and predictors of cognitive impairment among participants of the pilot phase, Intensive Blood Pressure (BP) Reduction in Acute Cerebral Hemorrhage Trial (INTERACT1). Methods: INTERACT1 was an open randomized trial of early intensive (target systolic BP <140 mm Hg) compared with contemporaneous guideline-recommended BP lowering in 404 patients with elevated systolic BP (150–220 mm Hg) within 6 h of ICH onset. Cognitive impairment was defined by scores ≤24 on the Mini-Mental State Examination (MMSE) assessed by interview on follow-up at 90 days. Results: A total of 231 (64.5%) of 358 90-day survivors had MMSE scores for analyses, and 75 (32.5%) had cognitive impairment. In multivariable analysis, older age (OR 2.48, 95% CI 1.73–3.56 per 10-year increase; p < 0.001), female sex (OR 2.06, 95% CI 1.00–4.23; p = 0.049), prior ICH (OR 2.87, 95% CI 1.08–7.65; p = 0.035), high baseline National Institute of Health Stroke Scale score (OR 1.06, 95% CI 1.00–1.13; p = 0.044), and high mean systolic BP over the first 24 h post-randomization (OR 1.34, 95% CI 1.07–1.68/10 mm Hg increase; p = 0.011) were independently associated with cognitive impairment. Conclusions: One third of patients have significant cognitive impairment early after ICH, which is more frequent in the elderly, females, those with prior ICH, and more severe initial neurological deficit and with persistently high early systolic BP.

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