Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound

Stroke Clinical Trial

Official title:

Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472224
• Other study ID #: H-1-2011-069
• Status: Completed
• Phase: N/A
• First received: November 13, 2011
• Last updated: July 22, 2013
• Start date: October 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Stroke

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, Neurologisk afdeling	Copenhagen	Region H

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. doi: 10.1161/STROKEAHA.108.524249. Epub 2009 Jan 22. — View Citation

Seidel G, Kaps M, Dorndorf W. Transcranial color-coded duplex sonography of intracerebral hematomas in adults. Stroke. 1993 Oct;24(10):1519-27. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references