Skip to main content
OpenTrials
Completed

NCT Number: NCT01472224

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg Hospital, Neurologisk afdeling

Copenhagen, Region H, 2400, Denmark

About this study

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:

  • Bedside ultrasound volume assessment is accurate in estimating the haematoma volume compared to computer tomography (CT) and can dynamically document the haematoma expansion.
  • The haematoma expansion is accompanied by neurological deterioration and happens only with patients with CT demonstrated spot signs.
  • The haematoma expansion is observed with patients with high blood pressure.

Aim of study:

  • To validate the accuracy of ultrasound (US) compared to CT in estimating haematoma volume with ICH patients.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 16, 2011
Registry last updated
Jul 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.