Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial

The Lancet

Volumn 389, Issue 10069, 2017, Pages 603-611

  Hanley, Daniel F ^a   Lane, Karen ^a   McBee, Nichol ^a   Ziai, Wendy ^a   Tuhrim, Stanley ^b   Lees, Kennedy R ^c   Dawson, Jesse ^c   Gandhi, Dheeraj ^d   Ullman, Natalie ^a   Mould, W Andrew ^a   Mayo, Steven W ^e   Mendelow, A David ^f   Gregson, Barbara ^f   Butcher, Kenneth ^g   Vespa, Paul ^h   Wright, David W ⁱ   Kase, Carlos S ^j   Carhuapoma, J Ricardo ^a   Keyl, Penelope M ^a   Diener West, Marie ^k   Muschelli, John ^k   Betz, Joshua F ^k   Thompson, Carol B ^k   Sugar, Elizabeth A ^k   Yenokyan, Gayane ^k   Janis, Scott ^l   John, Sayona ^m   Harnof, Sagi ⁿ   Lopez, George A ^o   Aldrich, E Francois ^d   Harrigan, Mark R ^p   Ansari, Safdar ^q   Jallo, Jack ^r   Caron, Jean Louis ^s   LeDoux, David ^t   Adeoye, Opeolu ^u   Zuccarello, Mario ^u   Adams, Harold P ^v   Rosenblum, Michael ^k   Thompson, Richard E ^k   Awad, Issam A ^w   more..

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF GLASGOW   (United Kingdom)

^d UNIVERSITY OF MARYLAND   (United States)

^e Emissary International LLC   (United States)

^f NEWCASTLE UNIVERSITY   (United Kingdom)

^g UNIVERSITY OF ALBERTA   (Canada)

^h UNIVERSITY OF CALIFORNIA   (United States)

ⁱ EMORY UNIVERSITY   (United States)

^j BOSTON UNIVERSITY   (United States)

^k JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^l NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE   (United States)

^m RUSH UNIVERSITY   (United States)

ⁿ SHEBA MEDICAL CENTER   (Israel)

^o UNIVERSITY OF TEXAS   (United States)

^p UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^q UNIVERSITY OF UTAH   (United States)

^r THOMAS JEFFERSON UNIVERSITY HOSPITAL   (United States)

^s UNIVERSITY OF TEXAS AT SAN ANTONIO   (United States)

^t LONG ISLAND JEWISH MEDICAL CENTER   (United States)

^u UNIVERSITY OF CINCINNATI   (United States)

^v UNIVERSITY OF IOWA   (United States)

^w UNIVERSITY OF CHICAGO   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALTEPLASE; PLACEBO; SODIUM CHLORIDE; FIBRINOLYTIC AGENT; TISSUE PLASMINOGEN ACTIVATOR;

ADULT; AGED; ARTICLE; BLEEDING; BRAIN HEMORRHAGE; BRAIN VENTRICULITIS; CASE FATALITY RATE; CEREBROVASCULAR ACCIDENT; CLINICAL OUTCOME; CONNECTIVE TISSUE DISEASE; CONTROLLED STUDY; DISEASE SEVERITY; DRAIN; DRUG EFFICACY; DRUG SAFETY; FEMALE; FIBRINOLYTIC THERAPY; FOLLOW UP; FUNCTIONAL STATUS; GASTROINTESTINAL DISEASE; HAZARD RATIO; HEART DISEASE; HEMATOLOGIC DISEASE; HEPATOBILIARY DISEASE; HUMAN; INFECTION; KIDNEY DISEASE; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MENTAL DISEASE; METABOLIC DISORDER; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; NUTRITIONAL DISORDER; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RANKIN SCALE; RESPIRATORY TRACT DISEASE; THALAMUS; THORAX DISEASE; URINARY TRACT DISEASE; VASCULAR DISEASE; X-RAY COMPUTED TOMOGRAPHY; BRAIN VENTRICLE HEMORRHAGE; CLINICAL TRIAL; DIAGNOSTIC IMAGING; LAVAGE; MIDDLE AGED; PROCEDURES; PROPORTIONAL HAZARDS MODEL; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

AGED; CEREBRAL INTRAVENTRICULAR HEMORRHAGE; DRAINAGE; FEMALE; FIBRINOLYTIC AGENTS; HUMANS; MALE; MIDDLE AGED; PROPORTIONAL HAZARDS MODELS; SEVERITY OF ILLNESS INDEX; SODIUM CHLORIDE; STROKE; THERAPEUTIC IRRIGATION; TISSUE PLASMINOGEN ACTIVATOR; TOMOGRAPHY, X-RAY COMPUTED; TREATMENT OUTCOME;

EID: 85009266881     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(16)32410-2     Document Type: Article

References (25)

1. 1 Hanley, DF, Intraventricular hemorrhage severity factor and treatment target in spontaneous intracerebral hemorrhage. Stroke 40 (2009), 1533–1538.
2. 2 Hansen, BM, Morgan, TC, Betz, J, et al. Intraventricular extension of supratentorial intracerebral hemorrhage: the modified graeb scale improves outcome prediction in lund stroke register. Neuroepidemiology 46 (2015), 43–50.
3. 3 Tuhrim, S, Horowitz, DR, Sacher, M, Godbold, JH, Volume of ventricular blood is an important determinant of outcome in supratentorial intracerebral hemorrhage. Critical Care Med 27 (1999), 617–621.
4. 4 Qureshi, AI, Tuhrim, S, Broderick, JP, Batjer, HH, Hondo, H, Hanley, DF, Spontaneous intracerebral hemorrhage. New Engl J Med 344 (2001), 1450–1460.
5. 5 Moradiya, Y, Murthy, SB, Newman-Toker, DE, Hanley, DF, Ziai, WC, Intraventricular thrombolysis in intracerebral hemorrhage requiring ventriculostomy a decade-long real-world experience. Stroke 45 (2014), 2629–2635.
6. 6 Naff, N, Williams, MA, Keyl, PM, et al. Low-dose recombinant tissue-type plasminogen activator enhances clot resolution in brain hemorrhage the intraventricular hemorrhage thrombolysis trial. Stroke 42 (2011), 3009–3016.
7. 7 Gaberel, T, Magheru, C, Parienti, J-J, Huttner, HB, Vivien, D, Emery, E, Intraventricular fibrinolysis versus external ventricular drainage alone in intraventricular hemorrhage a meta-analysis. Stroke 42 (2011), 2776–2781.
8. 8 Nieuwkamp, DJ, de Gans, K, Rinkel, GJ, Algra, A, Treatment and outcome of severe intraventricular extension in patients with subarachnoid or intracerebral hemorrhage: a systematic review of the literature. J Neurology 247 (2000), 117–121.
9. 9 Staykov, D, Bardutzky, J, Huttner, HB, Schwab, S, Intraventricular fibrinolysis for intracerebral hemorrhage with severe ventricular involvement. Neurocritical Care 15 (2011), 194–209.
10. 10 Ziai, WC, Muschelli, J, Thompson, CB, et al. Factors affecting clot lysis rates in patients with spontaneous intraventricular hemorrhage. Stroke 43 (2012), 1234–1239.
11. 11 Hanley, DF, Thompson, RE, Muschelli, J, et al., for the MISTIE Investigators. Safety and efficacy of minimally invasive surgery plus alteplase in intracerebral haemorrhage evacuation (MISTIE): a randomised, controlled, open-label, phase 2 trial. Lancet Neurol 15 (2016), 1228–1237.
12. 12 Josephson, CB, White, PM, Krishan, A, Al-Shahi Salman, R, Computed tomography angiography or magnetic resonance angiography for detection of intracranial vascular malformations in patients with intracerebral haemorrhage. Cochrane Database Syst Rev, 9, 2014 CD009372.
13. 13 Ziai, WC, Tuhrim, S, Lane, K, et al. A multicenter, randomized, double-binded, placebo-controlled phase III study of Clot Lysis Evaluation of Accelerated Resolution of Intraventricular Hemorrhage (CLEAR III). Int J Stroke 9 (2014), 536–542.
14. 14 Pocock, SJ, Simon, R, Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 31 (1975), 103–115.
15. 15 Weir, CJ, Lees, KR, Comparison of stratification and adaptive methods for treatment allocation in an acute stroke clinical trial. Stats Med 22 (2003), 705–726.
16. 16 Morgenstern, L, Hemphill, J 3rd, Anderson, C, et al. American Heart Association Stroke Council and Council on Cardiovascular Nursing. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 41 (2010), 2108–2129.
17. 17 Broderick, J, Connolly, S, Feldmann, E, et al. American Stroke Association Stroke Council American Heart Association/American Stroke Association High Blood Pressure Research Council, Quality of Care and Outcomes in Research Interdisciplinary Working Group. Guidelines for the management of spontaneous intracerebral hemorrhage in adults: 2007 update: a guideline from the American heart association/American stroke association stroke council, high blood pressure research council, and the quality of care and outcomes in research interdisciplinary working group. Circulation 116 (2007), e391–e413.
18. 18 Mould, WA, Carhuapoma, JR, Muschelli, J, et al. Minimally invasive surgery plus recombinant tissue-type plasminogen activator for intracerebral hemorrhage evacuation decreases perihematomal edema. Stroke 44 (2013), 627–634.
19. 19 Morgan, TC, Dawson, J, Spengler, D, et al. The modified Graeb score an enhanced tool for intraventricular hemorrhage measurement and prediction of functional outcome. Stroke 44 (2013), 635–641.
20. 20 Efron, B, Better bootstrap confidence intervals. J Am Stat Assoc 82 (1987), 171–185.
21. 21 Mattle, HP, Raabe, A, CLEAR Intraventricular Hemorrhage More Than a Glimmer of Hope. Stroke 42 (2011), 2999–3000.
22. 22 Teasdale, GM, Pettigrew, Le, Wilson, Jl, Murray, G, Jennett, B, Analyzing outcome of treatment of severe head injury: a review and update on advancing the use of the Glasgow Outcome Scale. J Neurotrauma 15 (1998), 587–597.
23. 23 Hinson, HE, Melnychuk, E, Muschelli, J, Hanley, DF, Awad, IA, Ziai, WC, Drainage efficiency with dual versus single catheters in severe intraventricular hemorrhage. Neurocritical Care 16 (2012), 399–405.
24. 24 Vespa, PM, Martin, N, Zuccarello, M, Awad, I, Hanley, DF, Surgical trials in intracerebral hemorrhage. Stroke 44 (2013), S79–S82.
25. 25 Selker, HP, Oye, KA, Eichler, HG, et al. A proposal for integrated efficacy-to-effectiveness (E2E) clinical trials. Clinical Pharmacology Therapeutics 95 (2014), 147–153.