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
  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:


Further study details as provided by Bispebjerg Hospital:

Estimated Enrollment: 30
Study Start Date: October 2011
Study Completion Date: December 2012
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:

  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Bispebjerg Hospital, Neurologisk afdeling
Copenhagen, Region H, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Hanne Christensen, MD, Ph.D, DMSci Bispebjerg Hospital - Department of neurology
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: July 22, 2013
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:
Cerebral Hemorrhage
Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014