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StrokeNCT01472224

Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound

An observational study of Stroke and Cerebral Hemorrhage, run by Bispebjerg Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Cerebral Hemorrhage
How many people
30 participants
Where
1 siteDenmark
Study dates
Oct 2011to Dec 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Bispebjerg Hospital, Neurologisk afdeling

    Copenhagen, Region H, 2400

Other trials in Denmark

About this study

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.

Read the 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:

  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.
Keywords
Transcranial ultrasound, Haematoma expansion
Medical subject headings
Stroke, Cerebral Hemorrhage

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01472224
Sponsor's protocol ID
H-1-2011-069
Status last verified
Jul 2013
First submitted
13 Nov 2011
Last updated
24 Jul 2013
Results posted
No
Data monitoring committee
No

Publications

  • Mayer SA, Rincon F. Treatment of intracerebral haemorrhage. Lancet Neurol. 2005 Oct;4(10):662-72. doi: 10.1016/S1474-4422(05)70195-2.

    PubMed 16168935

  • 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.

    PubMed 8996478

  • 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.

    PubMed 8322400

  • 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.

    PubMed 16636233

  • 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.

    PubMed 15304576

  • 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.

    PubMed 15118169

  • 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.

    PubMed 8711791

  • 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.

    PubMed 19650356

  • 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.

    PubMed 10148076

  • 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.

    PubMed 18648201

  • 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.

    PubMed 9836768

  • 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.

    PubMed 19164795

  • 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.

    PubMed 8378956

  • 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.

    PubMed 24627116

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Cerebral Hemorrhage, run by Bispebjerg Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01472224, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2013.

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