Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound

July 22, 2013 updated by: Hanne Christensen, Bispebjerg Hospital

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region H
      • Copenhagen, Region H, Denmark, 2400
        • Bispebjerg Hospital, Neurologisk Afdeling

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Hanne Christensen, MD, Ph.D, DMSci, Bispebjerg Hospital - Department of Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

November 13, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (ESTIMATE)

November 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 22, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2011-069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe