Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanne Christensen, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01472224
First received: November 13, 2011
Last updated: July 22, 2013
Last verified: July 2013

November 13, 2011
July 22, 2013
October 2011
December 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01472224 on ClinicalTrials.gov Archive Site
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Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound
Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound

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.

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.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Stroke
  • Cerebral Hemorrhage
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01472224
H-1-2011-069
No
Hanne Christensen, Bispebjerg Hospital
Bispebjerg Hospital
Not Provided
Principal Investigator: Hanne Christensen, MD, Ph.D, DMSci Bispebjerg Hospital - Department of neurology
Bispebjerg Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP