Volume Measurement and Progression Surveillance of Intrac... | NCT01472224

Studies
Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound

NCT01472224

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Jul 24, 2013Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Stroke
Cerebral Hemorrhage

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Nov 13, 2011

First Submission Date that Met QC Criteria

Nov 15, 2011

First Posted Date

Nov 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2013

Last Update Posted Date

Jul 24, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hanne Christensen, Associate Research Professor, Consultant neurologist, Bispebjerg HospitalPrincipal Investigator

Lead Sponsor

Bispebjerg HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hanne Christensen, MD, Ph.D, DMSci	Bispebjerg Hospital - Department of neurology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital, Neurologisk afdeling		Copenhagen	Region H	2400	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16168935	Background	Mayer SA, Rincon F. Treatment of intracerebral haemorrhage. Lancet Neurol. 2005 Oct;4(10):662-72. doi: 10.1016/S1474-4422(05)70195-2.
8996478	Background	Brott T, Broderick J, Kothari R, Barsan W, Tomsick T, Sauerbeck L, Spilker J, Duldner J, Khoury J. Early hemorrhage growth in patients with intracerebral hemorrhage. Stroke. 1997 Jan;28(1):1-5. doi: 10.1161/01.str.28.1.1.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D020521	Stroke
D002543	Cerebral Hemorrhage