Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound - Full Text View

Purpose

This study investigates the ability of ultrasound to measure the volume of a brain hemorrhage in the acute phase after hospital admission.

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.

Condition
Stroke Cerebral Hemorrhage

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound

Resource links provided by NLM:

Genetics Home Reference related topics: COL4A1-related brain small-vessel disease

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Estimated Enrollment:	30
Study Start Date:	October 2011
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Detailed Description:

This study investigates the use of transcranial ultrasound (TCU) for the surveillance of patients with intracerebral hemorrhages. Using transcranial ultrasound makes it possible to visualize and follow the bleeding progression through 3 points of the scull where the bone is thin enough to allow the penetration of sound waves. This can be done at bedside. Today the investigators do not know for sure if clinical parameters determine a haematoma expansion. TCU will allow us to follow the haematoma progression serially in the acute phase and relate the haematoma expansion to parameters like blood pressure, neurological status (NIHSS-score) and radiological signs of ongoing bleeding (spot signs) on CT-angiogram (CTA).

Hypothesis:

Bedside ultrasound volume assessment is accurate in estimating the haematoma volume compared to computer tomography (CT) and can dynamically document the haematoma expansion.
The haematoma expansion is accompanied by neurological deterioration and happens only with patients with CT demonstrated spot signs.
The haematoma expansion is observed with patients with high blood pressure.

Aim of study:

To validate the accuracy of ultrasound (US) compared to CT in estimating haematoma volume with ICH patients.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Acutely admitted stroke patients with intracerebral hemorrhage. Hemorrhage not older than 4,5 hours

Criteria

Inclusion Criteria:

Patients admitted to Bispebjerg Hospital stroke unit with CT demonstrated spontaneous ICH
Hospital admission within 4,5 hours after symptom onset
CTA on admission
GCS>8 (non-comatose)

Exclusion Criteria:

Lack of informed consent
Underlying Pathology (tumor, AVM, aneurism)
Lack of temporal bone window

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472224

Locations

Denmark
Bispebjerg Hospital, Neurologisk afdeling	Recruiting
Copenhagen, Region H, Denmark, 2400
Contact: Hanne Christiensen, MD, Ph.D, DMSci +4535312754 hchr0039@bbh.regionh.dk
Principal Investigator: Hanne Christiensen, MD, Ph.D, DMSci

Sponsors and Collaborators

Bispebjerg Hospital

Investigators

Principal Investigator:

Hanne Christensen, MD, Ph.D, DMSci

Bispebjerg Hospital - Department of neurology

More Information

Publications:

Mayer SA, Rincon F. Treatment of intracerebral haemorrhage. Lancet Neurol. 2005 Oct;4(10):662-72. Review.

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.

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.

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.

Leira R, Dávalos 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.

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. 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.

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.

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.

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. Epub 2008 Jul 23.

Mäurer 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.

Pérez ES, Delgado-Mederos R, Rubiera M, Delgado P, Ribó 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. 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.

Responsible Party:	Hanne Christensen, Associate Research Professor, Consultant neurologist, Bispebjerg Hospital
ClinicalTrials.gov Identifier:	NCT01472224 History of Changes
Other Study ID Numbers:	H-1-2011-069
Study First Received:	November 13, 2011
Last Updated:	August 16, 2012
Health Authority:	Denmark: National Board of Health Denmark: Danish Dataprotection Agency Denmark: Ethics Committee

Keywords provided by Bispebjerg Hospital:

Transcranial ultrasound
Haematoma expansion

Additional relevant MeSH terms:

Hemorrhage
Stroke
Cerebral Hemorrhage
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages

ClinicalTrials.gov processed this record on May 22, 2013