Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound
NCT ID: NCT01472224
Last Updated: 2013-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2011-10-31
2012-12-31
Brief Summary
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It is known that approximately 30% of patients admitted with a brain hemorrhage will suffer from enlargement of the hematoma within the first hours after admission.
In this study the investigators measure the volume of the hematoma every 30 minutes up to 6 hours after admission and every 2 hours between 6-12 hours.
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Detailed Description
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Hypothesis:
1. Bedside ultrasound volume assessment is accurate in estimating the haematoma volume compared to computer tomography (CT) and can dynamically document the haematoma expansion.
2. The haematoma expansion is accompanied by neurological deterioration and happens only with patients with CT demonstrated spot signs.
3. The haematoma expansion is observed with patients with high blood pressure.
Aim of study:
1. To validate the accuracy of ultrasound (US) compared to CT in estimating haematoma volume with ICH patients.
2. To measure ICH volume serially in the acute phase using US and up to 12 hours aiming at:
* Describing the timing of the haematoma expansion.
* Relating to neurological deterioration, systemic blood pressure and detection of spot signs on CTA.
Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Hospital admission within 4,5 hours after symptom onset
* CTA on admission
* GCS\>8 (non-comatose)
Exclusion Criteria
* Underlying Pathology (tumor, AVM, aneurism)
* Lack of temporal bone window
18 Years
ALL
No
Sponsors
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Bispebjerg Hospital
OTHER
Responsible Party
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Hanne Christensen
Associate Research Professor, Consultant neurologist
Principal Investigators
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Hanne Christensen, MD, Ph.D, DMSci
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital - Department of neurology
Locations
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Bispebjerg Hospital, Neurologisk afdeling
Copenhagen, Region H, Denmark
Countries
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References
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Mayer SA, Rincon F. Treatment of intracerebral haemorrhage. Lancet Neurol. 2005 Oct;4(10):662-72. doi: 10.1016/S1474-4422(05)70195-2.
Brott T, Broderick J, Kothari R, Barsan W, Tomsick T, Sauerbeck L, Spilker J, Duldner J, Khoury J. Early hemorrhage growth in patients with intracerebral hemorrhage. Stroke. 1997 Jan;28(1):1-5. doi: 10.1161/01.str.28.1.1.
Broderick JP, Brott TG, Duldner JE, Tomsick T, Huster G. Volume of intracerebral hemorrhage. A powerful and easy-to-use predictor of 30-day mortality. Stroke. 1993 Jul;24(7):987-93. doi: 10.1161/01.str.24.7.987.
Davis SM, Broderick J, Hennerici M, Brun NC, Diringer MN, Mayer SA, Begtrup K, Steiner T; Recombinant Activated Factor VII Intracerebral Hemorrhage Trial Investigators. Hematoma growth is a determinant of mortality and poor outcome after intracerebral hemorrhage. Neurology. 2006 Apr 25;66(8):1175-81. doi: 10.1212/01.wnl.0000208408.98482.99.
Leira R, Davalos A, Silva Y, Gil-Peralta A, Tejada J, Garcia M, Castillo J; Stroke Project, Cerebrovascular Diseases Group of the Spanish Neurological Society. Early neurologic deterioration in intracerebral hemorrhage: predictors and associated factors. Neurology. 2004 Aug 10;63(3):461-7. doi: 10.1212/01.wnl.0000133204.81153.ac.
Ohwaki K, Yano E, Nagashima H, Hirata M, Nakagomi T, Tamura A. Blood pressure management in acute intracerebral hemorrhage: relationship between elevated blood pressure and hematoma enlargement. Stroke. 2004 Jun;35(6):1364-7. doi: 10.1161/01.STR.0000128795.38283.4b. Epub 2004 Apr 29.
Kothari RU, Brott T, Broderick JP, Barsan WG, Sauerbeck LR, Zuccarello M, Khoury J. The ABCs of measuring intracerebral hemorrhage volumes. Stroke. 1996 Aug;27(8):1304-5. doi: 10.1161/01.str.27.8.1304.
Thompson AL, Kosior JC, Gladstone DJ, Hopyan JJ, Symons SP, Romero F, Dzialowski I, Roy J, Demchuk AM, Aviv RI; PREDICTS/Sunnybrook ICH CTA Study Group. Defining the CT angiography 'spot sign' in primary intracerebral hemorrhage. Can J Neurol Sci. 2009 Jul;36(4):456-61. doi: 10.1017/s0317167100007782.
Becker G, Winkler J, Hofmann E, Bogdahn U. Differentiation between ischemic and hemorrhagic stroke by transcranial color-coded real-time sonography. J Neuroimaging. 1993 Jan;3(1):41-7. doi: 10.1111/jon19933141.
Kern R, Kablau M, Sallustio F, Fatar M, Stroick M, Hennerici MG, Meairs S. Improved detection of intracerebral hemorrhage with transcranial ultrasound perfusion imaging. Cerebrovasc Dis. 2008;26(3):277-83. doi: 10.1159/000147456. Epub 2008 Jul 23.
Maurer M, Shambal S, Berg D, Woydt M, Hofmann E, Georgiadis D, Lindner A, Becker G. Differentiation between intracerebral hemorrhage and ischemic stroke by transcranial color-coded duplex-sonography. Stroke. 1998 Dec;29(12):2563-7. doi: 10.1161/01.str.29.12.2563.
Perez ES, Delgado-Mederos R, Rubiera M, Delgado P, Ribo M, Maisterra O, Ortega G, Alvarez-Sabin J, Molina CA. Transcranial duplex sonography for monitoring hyperacute intracerebral hemorrhage. Stroke. 2009 Mar;40(3):987-90. doi: 10.1161/STROKEAHA.108.524249. Epub 2009 Jan 22.
Seidel G, Kaps M, Dorndorf W. Transcranial color-coded duplex sonography of intracerebral hematomas in adults. Stroke. 1993 Oct;24(10):1519-27. doi: 10.1161/01.str.24.10.1519.
Ovesen C, Christensen AF, Krieger DW, Rosenbaum S, Havsteen I, Christensen H. Time course of early postadmission hematoma expansion in spontaneous intracerebral hemorrhage. Stroke. 2014 Apr;45(4):994-9. doi: 10.1161/STROKEAHA.113.003608. Epub 2014 Mar 13.
Other Identifiers
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H-1-2011-069
Identifier Type: -
Identifier Source: org_study_id
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