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  • 1
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    Online Resource
    Time Course of Early Hematoma Expansion in Acute Spot-Sign Positive Intracerebral Hemorrhage: Prespecified Analysis of the SPOTLIGHT Randomized Clinical Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  Stroke Vol. 54, No. 3 ( 2023-03), p. 715-721
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 54, No. 3 ( 2023-03), p. 715-721
    Abstract: In the SPOTLIGHT trial (Spot Sign Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy), patients with a computed tomography (CT) angiography spot-sign positive acute intracerebral hemorrhage were randomized to rFVIIa (recombinant activated factor VIIa; 80 μg/kg) or placebo within 6 hours of onset, aiming to limit hematoma expansion. Administration of rFVIIa did not significantly reduce hematoma expansion. In this prespecified analysis, we aimed to investigate the impact of delays from baseline imaging to study drug administration on hematoma expansion. Methods: Hematoma volumes were measured on the baseline CT, early post-dose CT, and 24 hours CT scans. Total hematoma volume (intracerebral hemorrhage+intraventricular hemorrhage) change between the 3 scans was calculated as an estimate of how much hematoma expansion occurred before and after studying drug administration. Results: Of the 50 patients included in the trial, 44 had an early post-dose CT scan. Median time (interquartile range) from onset to baseline CT was 1.4 hours (1.2–2.6). Median time from baseline CT to study drug was 62.5 (55–80) minutes, and from study drug to early post-dose CT was 19 (14.5–30) minutes. Median (interquartile range) total hematoma volume increased from baseline CT to early post-dose CT by 10.0 mL (−0.7 to 18.5) in the rFVIIa arm and 5.4 mL (1.8–8.3) in the placebo arm ( P =0.96). Median volume change between the early post-dose CT and follow-up scan was 0.6 mL (−2.6 to 8.3) in the rFVIIa arm and 0.7 mL (−1.6 to 2.1) in the placebo arm ( P =0.98). Total hematoma volume decreased between the early post-dose CT and 24-hour scan in 44.2% of cases (rFVIIa 38.9% and placebo 48%). The adjusted hematoma growth in volume immediately post dose for FVIIa was 0.998 times that of placebo ([95% CI, 0.71–1.43]; P =0.99). The hourly growth in FFVIIa was 0.998 times that for placebo ([95% CI, 0.994–1.003]; P =0.50; Table 3). Conclusions: In the SPOTLIGHT trial, the adjusted hematoma volume growth was not associated with Factor VIIa treatment. Most hematoma expansion occurred between the baseline CT and the early post-dose CT, limiting any potential treatment effect of hemostatic therapy. Future hemostatic trials must treat intracerebral hemorrhage patients earlier from onset, with minimal delay between baseline CT and drug administration. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01359202.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.121.038475
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
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  • 2
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    Acute Blood Pressure Reduction in Patients With Intracerebral Hemorrhage Does Not Result in Borderzone Region Hypoperfusion
    Ovid Technologies (Wolters Kluwer Health) ; 2014
    In:  Stroke Vol. 45, No. 10 ( 2014-10), p. 2894-2899
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. 10 ( 2014-10), p. 2894-2899
    Abstract: The Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial (ICH ADAPT) demonstrated blood pressure (BP) reduction does not affect mean perihematoma or hemispheric cerebral blood flow. Nonetheless, portions of the perihematoma and borderzones may reach ischemic thresholds after BP reduction. We tested the hypothesis that BP reduction after intracerebral hemorrhage results in increased critically hypoperfused tissue volumes. Methods— Patients with Intracerebral hemorrhage were randomized to a target systolic BP (SBP) of 〈 150 or 〈 180 mm Hg and imaged with computed tomographic perfusion 2 hours later. The volumes of tissue below cerebral blood flow thresholds for ischemia ( 〈 18 mL/100 g/min) and infarction ( 〈 12 mL/100 g/min) were calculated as a percentage of the total volume within the internal and external borderzones and the perihematoma region. Results— Seventy-five patients with intracerebral hemorrhage were randomized a median (interquartile range) of 7.8 (13.3) hours from onset. Acute hematoma volume was 17.8 (27.1) mL and mean SBP was 183±22 mm Hg. At the time of computed tomographic perfusion (2.3 [1.0] hours after randomization), SBP was lower in the 〈 150 mm Hg (n=37; 140±18 mm Hg) than in the 〈 180 mm Hg group (n=36; 162±12 mm Hg; P 〈 0.001). BP treatment did not affect the percentage of total borderzone tissue with cerebral blood flow 〈 18 (14.7±13.6 versus 15.6±13.7%; P =0.78) or 〈 12 mL/100 g/min (5.1±5.1 versus 5.8±6.8%; P =0.62). Similar results were found in the perihematoma region. Low SBP load (fraction of time with SBP 〈 150 mmHg) did not predict borderzone tissue volume with cerebral blood flow 〈 18 mL/100 g/min (β=0.023 [−0.073, 0.119]). Conclusions— BP reduction does not increase the volume of critically hypoperfused borderzone or perihematoma tissue. These data support the safety of early BP reduction in intracerebral hemorrhage. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00963976.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.114.005614
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
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  • 3
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    Abstract WP295: Acute Blood Pressure Reduction in Intracerebral Hemorrhage Patients Does Not Increase Hypoperfused Tissue Volume: a CT Perfusion Threshold Study
    Ovid Technologies (Wolters Kluwer Health) ; 2013
    In:  Stroke Vol. 44, No. suppl_1 ( 2013-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. suppl_1 ( 2013-02)
    Abstract: Background: The Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial (ICH ADAPT) demonstrated that aggressive blood pressure (BP) reduction does not affect mean perihematoma cerebral blood flow (CBF). It remains unknown if portions of the perihematoma region or watershed vascular territories (borderzones, BZs) reach ischemic thresholds after BP reduction. We tested the hypothesis that aggressive BP reduction was associated with an increased volume of critically hypoperfused tissue in ICH ADAPT patients. Methods: ICH patients were randomized to a target systolic BP (SBP) of 〈 150 or 〈 180 mmHg and imaged with CT perfusion (CTP) 2h later. A 1cm perihematoma region, and ipsilateral and contralateral internal and external BZs were outlined. The volume of tissue below CBF thresholds for ischemia ( 〈 18ml/100g/min) and infarction ( 〈 12ml/100g/min) was calculated as a percentage of the total volume of each region of interest. Results: ICH patients (n=73) were randomized a median (IQR) of 7.8 (13.3) h from onset and imaged with CTP 2.3 (1.0) h later. Acute hematoma volume was 17.8 (27.1) ml and mean SBP was 183±22 mmHg. At the time of CTP, SBP was lower in the 〈 150 mmHg group (n=37, 140±18 mmHg) than the 〈 180 mmHg group (n=36, 162±12 mmHg, P 〈 0.001). Mean CBF in the perihematoma region did not differ between groups ( 〈 150 mmHg: 38.9±13.0 vs. 〈 180 mmHg: 38.5±10.9 ml/100g/min, P=0.86). BP treatment did not affect the percentage of perihematoma tissue with CBF 〈 18 (17.5±15.4 ( 〈 150 group) vs. 16.5±14.3% ( 〈 180 group), P=0.82) or 〈 12 ml/100g/min (7.0±7.2 vs. 6.6±7.6%, P=0.93). Similar results were found in all BZs. Linear regression revealed no relationship between low SBP load (the fraction of time between randomization and CTP with SBP 〈 150mmHg) and the percentage of perihematoma tissue with CBF 〈 18 (β=3.62, [-6.86, 14.10]) or 〈 12 ml/100g/min (β=1.89, [-3.30, 7.08]). There was no relationship between low SBP load and percentage of hypoperfused tissue in any BZ. Perfusion threshold analysis of time domain parameters and cerebral blood volume yielded similar results. Conclusion: BP reduction does not increase the volume of hypoperfused tissue, at any threshold examined, in the perihematoma region or any BZ. These data support the safety of early BP reduction in ICH.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.44.suppl_1.AWP295
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
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  • 4
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    Abstract TMP81: Cerebral Blood Flow and Blood Pressure Reduction Do Not Affect Perihematomal Edema Growth in Acute Intracerebral Hemorrhage
    Ovid Technologies (Wolters Kluwer Health) ; 2013
    In:  Stroke Vol. 44, No. suppl_1 ( 2013-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. suppl_1 ( 2013-02)
    Abstract: Background: Both vasogenic and cytotoxic (ischemic) processes have been postulated to play a role in perihematoma edema formation. In the Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial (ICH ADAPT), cerebral blood flow (CBF) was measured in ICH patients assigned to systolic blood pressure (SBP) targets of 〈 150 or 〈 180 mmHg. In this secondary analysis, we tested the hypotheses that edema growth is associated with reduced CBF and lower SBP. Methods: Non-contrast CT scans were obtained at baseline, 2h and 24h post-randomization. Mean relative CBF (rCBF) in the perihematoma region was calculated from raw CT Perfusion data obtained at 2h. Edema volume was measured using planimetric techniques and a Hounsfield unit threshold of ≤24 at baseline and 24h. Results: ICH patients were randomized (n=33 per group) at a median (IQR) of 7.6 (12.8) h after symptom onset. Mean SBP was significantly lower in the 〈 150 mmHg (139±21 mmHg) than the 〈 180 mmHg (163±11, p= 〈 0.0001) at the time of CTP. Mean perihematoma rCBF in the 〈 150 mmHg group (0.85±0.12) was similar to that in the 〈 180 mmHg group (0.88±0.09, p=0.34). Treatment groups were balanced with respect to baseline SBP (180±18 vs. 185±25 mmHg, p=0.39) and acute ICH volume (20.7±22.0 vs. 28.0±25.8 ml, p=0.22). In all patients, median edema volume increased significantly between the baseline 1.8(2.5) ml and 24 h scans (3.1 (5.1) ml, p 〈 0.0001). Linear regression indicated that ICH expansion predicted edema growth (β =0.3 [0.0, 0.2]). Lower perihematoma rCBF did not predict edema growth independently of ICH expansion (β =-0.2 [-229.5, 0.4] ). Mean edema growth in the 〈 150 group (2.4±6.9) was similar to that in the 〈 180 group (2.9±6.4, p=0.737). Edema growth was not predicted by SBP change (β=0.12 [-0.45, 1.22]). Neither low SBP load (fraction of time SBP 〈 150 mmHg over 24 h; β=0.07 [-0.13, 0.24]) nor high SBP load (time SBP 〉 180 mmHg; β=0.07 [-0.13, 0.24]) predicted edema growth. Conclusion: Perihematoma edema growth is explained by ICH volume expansion. Lower perihematoma CBF and BP treatment do not exacerbate edema growth. These data are not consistent with a cytotoxic mechanism of edema formation and support the safety of early BP treatment.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.44.suppl_1.ATMP81
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
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  • 5
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    The Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2013
    In:  Stroke Vol. 44, No. 3 ( 2013-03), p. 620-626
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. 3 ( 2013-03), p. 620-626
    Abstract: Acute blood pressure (BP) reduction aimed at attenuation of intracerebral hemorrhage (ICH) expansion might also compromise cerebral blood flow (CBF). We tested the hypothesis that CBF in acute ICH patients is unaffected by BP reduction. Methods— Patients with spontaneous ICH 〈 24 hours after onset and systolic BP 〉 150 mm Hg were randomly assigned to an intravenous antihypertensive treatment protocol targeting a systolic BP of 〈 150 mm Hg (n=39) or 〈 180 mm Hg (n=36). Patients underwent computed tomography perfusion imaging 2 hours postrandomization. The primary end point was perihematoma relative (relative CBF). Results— Treatment groups were balanced with respect to baseline systolic BP: 182±20 mm Hg ( 〈 150 mm Hg target group) versus 184±25 mm Hg ( 〈 180 mm Hg target group; P =0.60), and for hematoma volume: 25.6±30.8 versus 26.9±25.2 mL ( P =0.66). Mean systolic BP 2 hours after randomization was significantly lower in the 〈 150 mm Hg target group (140±19 vs 162±12 mm Hg; P 〈 0.001). Perihematoma CBF (38.7±11.9 mL/100 g per minute) was lower than in contralateral homologous regions (44.1±11.1 mL/100 g per minute; P 〈 0.001) in all patients. The primary end point of perihematoma relative CBF in the 〈 150 mm Hg target group (0.86±0.12) was not significantly lower than that in the 〈 180 mm Hg group (0.89±0.09; P =0.19; absolute difference, 0.03; 95% confidence interval −0.018 to 0.078). There was no relationship between the magnitude of BP change and perihematoma relative CBF in the 〈 150 mm Hg ( R =0.00005; 95% confidence interval, −0.001 to 0.001) or 〈 180 mm Hg target groups ( R =0.000; 95% confidence interval, −0.001 to 0.001). Conclusions— Rapid BP lowering after a moderate volume of ICH does not reduce perihematoma CBF. These physiological data indicate that acute BP reduction does not precipitate cerebral ischemia in ICH patients. Clinical Trial Registration Information— URL: http://clinicaltrials.gov . Unique Identifier: NCT00963976.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.111.000188
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
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  • 6
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    Online Resource
    Autoregulation of Cerebral Blood Flow is Preserved in Primary Intracerebral Hemorrhage
    Ovid Technologies (Wolters Kluwer Health) ; 2013
    In:  Stroke Vol. 44, No. 6 ( 2013-06), p. 1726-1728
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. 6 ( 2013-06), p. 1726-1728
    Abstract: Treatment of acute hypertension after intracerebral hemorrhage (ICH) is controversial. In the context of disrupted cerebral autoregulation, blood pressure (BP) reduction may cause decreased cerebral blood flow (CBF). We used serial computed tomography perfusion to test the hypothesis that CBF remains stable after BP reduction. Methods— Patients recruited within 72 hours of ICH were imaged with computed tomography perfusion before and after BP treatment. Change in perihematoma relative (r) CBF after BP treatment was the primary end point. Results— Twenty patients were imaged with computed tomography perfusion at a median (interquartile range) time from onset of 20.2 (25.7) hours and reimaged 2.1 (0.5) hours later, after BP reduction. Mean systolic BP in treated patients (n=16; 4 untreated as BP 〈 target at baseline) decreased significantly between the first (168±21 mm Hg) and second (141±19 mm Hg; P 〈 0.0001) computed tomography perfusion scans. The primary end point of rCBF was not affected by BP reduction (pretreatment=0.89±0.11; post-treatment=0.87±0.11 mL/100 g per minute; P =0.37). Linear regression showed no relationship between changes in systolic BP and perihematoma rCBF (β=0.001 [−0.002 to 0.003]; P =0.63). Conclusions— CBF remained stable after acute BP reduction, suggesting some preservation of cerebral autoregulation.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.113.001306
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
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  • 7
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    Abstract 113: The Intracerebral Haemorrhage Acutely Decreasing Arterial Pressure Trial (ICH ADAPT): Final Results.
    Ovid Technologies (Wolters Kluwer Health) ; 2013
    In:  Stroke Vol. 44, No. suppl_1 ( 2013-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. suppl_1 ( 2013-02)
    Abstract: Background: Acute blood pressure (BP) reduction aimed at attenuation of intracerebral hemorrhage (ICH) expansion might also result in a harmful compromise of cerebral blood flow (CBF) in the region surrounding the hematoma. We tested the hypothesis that CBF in acute ICH patients is affected by BP reduction. Methods: Seventy-five patients with spontaneous ICH with baseline systolic BP 〉 150 mmHg were randomly assigned to an intravenous antihypertensive treatment protocol (labetalol, hydralazine and enalapril) targeting a systolic BP of either 〈 150 mmHg or 〈 180 mmHg within 24 hours of symptom onset. Patients underwent CT perfusion (CTP) imaging 2 hours post-randomization. The primary endpoint was relative CBF (rCBF) within the 1 cm perihematoma region. Results: Treatment groups were balanced with respect to baseline systolic BP: 182±20 mmHg ( 〈 150 mmHg target group, n=39) vs. 184±25 mmHg ( 〈 180 mmHg target group, n=36, p=0.60), hematoma volume: 25.6±30.8 vs. 26.9±25.2 ml (p=0.66) and median (IQR) time to randomization: 7.8 (13.5) and 8.5 (11.9) h (p=0.94). Mean systolic BP two hours after randomization was significantly lower in the 〈 150 mmHg target group (140±19 vs 162±12 mmHg in the 〈 180 target group, p 〈 0.001). Perihematoma CBF (38.7±11.9 ml/100g/min) was lower than in contralateral homologous regions (44.1±11.1 ml/100g/min, p 〈 0.001) in all patients. The primary endpoint of perihematoma rCBF in the 〈 150 mmHg target group (0.86±0.12) was not significantly lower than that in the 〈 180 mmHg group (0.89±0.09, p=0.19; absolute difference 0.03 95% CI -0.018, 0.078). There was no relationship between the magnitude of the BP change and perihematoma rCBF in the 〈 150 mmHg (R=0.00005, 95% CI -0.001, 0.001) or 〈 180 mmHg target groups (R=0.000, 95% CI -0.001, 0.001). There were no effects on rCBF in patients treated within 6 hours (0.78±0.22 in the 〈 150 mmHg group and 0.88±0.10 in the 〈 180 mmHg group, p=0.08) or in those treated 6-24 hours after onset (0.85±0.21 in the 〈 150 mmHg group and 0.89±0.10 in the 〈 180 mmHg group, p=0.46). Conclusions: Rapid BP lowering following ICH does not reduce perihematoma CBF. These physiological data support the safety of acute and aggressive BP reduction following ICH.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.44.suppl_1.A113
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
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  • 8
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    Perihematoma Cerebral Blood Flow is Unaffected by Statin Use in Acute Intracerebral Hemorrhage Patients
    SAGE Publications ; 2015
    In:  Journal of Cerebral Blood Flow & Metabolism Vol. 35, No. 7 ( 2015-07), p. 1175-1180
    Details
    In: Journal of Cerebral Blood Flow & Metabolism, SAGE Publications, Vol. 35, No. 7 ( 2015-07), p. 1175-1180
    Abstract: Statin therapy has been associated with improved cerebral blood flow (CBF) and decreased perihematoma edema in animal models of intracerebral hemorrhage (ICH). We aimed to assess the relationship between statin use and cerebral hemodynamics in ICH patients. A post hoc analysis of 73 ICH patients enrolled in the Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial (ICH ADAPT). Patients presenting 〈 24 hours from ICH onset were randomized to a systolic blood pressure target 〈 150 or 〈 180 mm Hg with computed tomography perfusion imaging 2 hours after randomization. Cerebral blood flow maps were calculated. Hematoma and edema volumes were measured planimetrically. Regression models were used to assess the relationship between statin use, perihematoma edema and cerebral hemodynamics. Fourteen patients (19%) were taking statins at the time of ICH. Statin-treated patients had similar median (IQR Q25 to 75) hematoma volumes (21.1 (9.5 to 38.3) mL versus 14.5 (5.6 to 27.7) mL, P = 0.25), but larger median (IQR Q25 to 75) perihematoma edema volumes (2.9 (1.7 to 9.0) mL versus 2.2 (0.8 to 3.5) mL, P = 0.02) compared with nontreated patients. Perihematoma and ipsilateral hemispheric CBF were similar in both groups. A multivariate linear regression model revealed that statin use and hematoma volumes were independent predictors of acute edema volumes. Statin use does not affect CBF in ICH patients. Statin use, along with hematoma volume, are independently associated with increased perihematoma edema volume.
    Type of Medium: Online Resource
    ISSN: 0271-678X , 1559-7016
    URL: Article
    DOI: 10.1038/jcbfm.2015.36
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
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