Clinical trial NCT01472224: Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound
Official title: Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Cerebral Hemorrhage
Keywords: Transcranial ultrasound
Haematoma expansion
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acutely admitted stroke patients with intracerebral hemorrhage. Hemorrhage not older than 4,5 hours

Brief 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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital, Neurologisk afdeling
state: Region H
Study officials:
affiliation: Bispebjerg Hospital - Department of neurology
name: Hanne Christensen, MD, Ph.D, DMSci
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.