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  • Fam, Maged D  (3)
  • Hanley, Daniel  (3)
  • 1
    Online Resource
    Online Resource
    Symptomatic Hemorrhagic Complications in Clot Lysis: Evaluation of Accelerated Resolution of Intraventricular Hemorrhage Phase III Clinical Trial (CLEAR III): A Posthoc Root-Cause Analysis
    Ovid Technologies (Wolters Kluwer Health) ; 2018
    In:  Neurosurgery Vol. 83, No. 6 ( 2018-12), p. 1260-1268
    Details
    In: Neurosurgery, Ovid Technologies (Wolters Kluwer Health), Vol. 83, No. 6 ( 2018-12), p. 1260-1268
    Abstract: As intraventricular thrombolysis for intraventricular hemorrhage (IVH) has developed over the last 2 decades, hemorrhagic complications have remained a concern despite general validation of its safety in controlled trials in the Clot Lysis: Evaluation of Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR-IVH) program. OBJECTIVE To analyze factors associated with symptomatic bleeding following IVH with and without thrombolysis in conjunction with the recently completed CLEAR III trial. METHODS We reviewed safety reports on symptomatic bleeding events reported during the first year after randomization among subjects enrolled in the CLEAR III trial. Clinical and imaging data were retrieved through the trial database as part of ongoing quality and safety monitoring. A posthoc root-cause analysis was performed to identify potential factors predisposing to rebleeding in each case. Cases were classified according to onset of rebleeding (during dosing, early after dosing and delayed), the pattern of bleeding, and treatment rendered (alteplase vs saline). RESULTS Twenty subjects developed a secondary symptomatic intracranial hemorrhage constituting 4% of subjects. Symptomatic rebleeding events occurred during the dosing protocol (n = 9, 67% alteplase), early after the protocol (n = 5, 40% alteplase), and late (n = 6, 0% alteplase). Catheter-related hemorrhages were the most common (n = 7, 35%) followed by expansion or new intraventricular (n = 6, 30%) and intracerebral (n = 5, 25%) hemorrhages. Symptomatic hemorrhages during therapy resulted from a combination of treatment- and patient-related factors and were at most partially attributable to alteplase. Rebleeding after the dosing protocol primarily reflected patients’ risk factors. CONCLUSION Intraventricular thrombolysis marginally increases the overall risk of symptomatic hemorrhagic complications after IVH, and only during the treatment phase.
    Type of Medium: Online Resource
    ISSN: 0148-396X , 1524-4040
    URL: Article
    DOI: 10.1093/neuros/nyx587
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2018
    detail.hit.zdb_id: 135446-2
    detail.hit.zdb_id: 1491894-8
    Location Call Number Limitation Availability
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  • 2
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    Online Resource
    Abstract WMP108: A Root-Cause Analysis of Symptomatic Rebleeding With Clot Lysis: Evaluation of Accelerated Resolution of Intraventricular Hemorrhage Phase III Clinical Trial (CLEAR III)
    Ovid Technologies (Wolters Kluwer Health) ; 2017
    In:  Stroke Vol. 48, No. suppl_1 ( 2017-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 48, No. suppl_1 ( 2017-02)
    Abstract: Background: Thrombolytic therapy after intraventricular hemorrhage (IVH) is being used with increasing frequency in recent years, and was recently evaluated in a randomized, placebo controlled blinded prospective clinical trial (CLEAR III). Hemorrhagic complications have remained a concern with thrombolysis in hemorrhagic stroke. We herein present a root case analysis of all cases with adjudicated symptomatic rebleeding identified in the CLEAR III Trial. Methods: We reviewed safety reports on symptomatic rebleeding events encountered within one year from randomization among subjects enrolled in CLEA III trial, with prospectively articulated definitions and reporting standards. Medical and imaging data were retrieved through the trial database. We analyzed clinical presentation, baseline and follow-up imaging, laboratory abnormalities, medical and surgical management aspects that may have contributed to rebleeding. Subjects were individually analyzed and classified according to onset of (dosing period, early post-dosing and delayed) rebleeding, pattern of bleeding and treatment rendered (alteplase vs. saline), and potential factors contributing the rebleeding. Results: Twenty-one subjects developed a secondary symptomatic hemorrhage constituting 4% of subjects in the trial. Symptomatic rebleeding events took place during the dosing protocol (n=9, 6 in the alteplase group), early after the protocol (n=6, 2 in the alteplase group) and late (n=6, none in the alteplase group). Catheter-related hemorrhages were the most common (n=7, 33%) followed by intraventricular (n=6, 30%) and intracerebral hemorrhage (n=5, 25%). Rebleeding during the dosing period resulted from a combination of treatment- and patient-related factors and could be partially attributable to alteplase in 6 of 9 cases. Rebleeding after the dosing protocol was primarily dependent on patients’ risk factors. Conclusion: Overall risk of symptomatic hemorrhagic complications are low after intraventricular thrombolysis for IVH as long as safety protocols are followed as deployed in the clinical trial. Secondary prevention strategies are needed following the acute care phase to minimize rebleeds.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.48.suppl_1.wmp108
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
    detail.hit.zdb_id: 80381-9
    detail.hit.zdb_id: 1467823-8
    Location Call Number Limitation Availability
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  • 3
    Online Resource
    Online Resource
    Abstract WMP87: Inflammatory Response in Cerebrospinal Fluid is Triggered by Large Volume Intraventricular Hemorrhage
    Ovid Technologies (Wolters Kluwer Health) ; 2016
    In:  Stroke Vol. 47, No. suppl_1 ( 2016-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 47, No. suppl_1 ( 2016-02)
    Abstract: Introduction: Cerebrospinal fluid (CSF) pleocytosis has been consistently observed with intraventricular hemorrhage (IVH) in small case series. Its extent, time course, and relation to IVH volume and infection have never been studied in a large cohort with systematic data collection. Hypothesis: Inflammatory response in CSF follows a predictable pattern after IVH, and is more enhanced in cases with higher IVH volume and infection Method: We analyzed prospectively collected samples from 500 patients enrolled in the Clot Lysis Evaluation of Accelerated Resolution (CLEAR) phase III trial. Patients with obstructive IVH requiring external ventricular drainage (EVD) were randomized to receive thrombolytic or placebo injections via EVD. We analyzed 12,291 data points including daily peripheral WBC and RBC counts, CSF RBC, WBC and neutrophil count, protein and glucose. Corrected WBCs (coWBC) reflecting true inflammatory response in the CSF was calculated by controlling for RBC/WBC ratio in a contemporaneous blood sample of the patient. Consecutive values were adjusted to the date of ictus (day 0) and analyzed on days 1-9. Median daily values were chronologically plotted to define the temporal pattern for each parameter. Similar analyses were repeated after stratification based on IVH volume, time to EVD insertion, and presence of culture positive ventriculitis (14 cases, 3%) Result: CSF protein gradually declined with later clearance of RBCs after IVH. There was a surge in coWBC at days 3-5. All parameters of inflammatory response, and most notably the coWBC peak, were greater with larger volume of IVH. Subgroup analyses defined a threshold for significant inflammatory response with initial IVH volume 27mls (P=0.006). Bacterial ventriculitis resulted in significantly higher coWBCs (P 〈 0.001) and neutrophils (P=0.01), but only in cases with low volume IVH ( 〈 27ml) Conclusion: Inflammation is an integral response to IVH and is more pronounced with large IVH volume. Bacterial ventriculitis is associated with CSF leukocytosis exceeding the aseptic inflammatory response, notably in lower volume bleeds. These results form a basis for future correlation with treatment rendered, rate of IVH clearance and clinical outcome, with upcoming unblinding of the trial.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.47.suppl_1.wmp87
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2016
    detail.hit.zdb_id: 80381-9
    detail.hit.zdb_id: 1467823-8
    Location Call Number Limitation Availability
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    Online Resource
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