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Rheolytic Thrombectomy For Adult Intraventricular Haemorrhage

NCT02394678 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-04-06

No results posted yet for this study

Summary

Intraventricular haemorrhage (IVH) - bleeding into the normal fluid spaces (ventricles) within the brain - is associated with a high risk of death or significant long-term disability. IVH leads to an increase pressure within the head and triggers inflammation and swelling in the surrounding brain. The ideal treatment for IVH would both rapidly relieve pressure and safely remove as much blood as possible to prevent any further injury to the brain. Currently, patients are managed by inserting a tube into the ventricle that drains fluid to the outside and helps reduce pressure, but does not address the blood clot itself, which naturally dissolves only over several days or weeks.

Furthermore, these drains frequently block because of blood clots that for within them. If that occurs a repeat operation is required to replace them. Experimental treatments include infusing drugs to accelerate clot breakdown but this can nonetheless still take a number of days and the process introduces a risk of infection and fresh bleeding. Surgery to remove the blood clot is hazardous, technically challenging, and generally not very successful. Therefore, at the present time, none of the available options achieve all the stated goals of IVH treatment and there is an unmet need for better interventions.

In this study the investigators propose to pilot a novel instrument that employs a high pressure but very localised microjet of water to mechanically disrupt blood clots and then sucks the debris away. This technique has been highly successful in reopening blocked arteries in the heart and, importantly, does so without damaging the underlying vessel lining. In the context of IVH, this should allow rapid removal of blood from the ventricles while causing minimal trauma to the brain. Clearing the blood early will prevent the build-up of pressure and inflammation, and improve the chances of patients making a good recovery.

Conditions

  • Intraventricular Hemorrhage

Interventions

DEVICE

AngioJet Thrombectomy System

Mechanical removal of blood, using a pressurised jet of water, from ventricles of patients suffering from intraventricular haemorrhage

Sponsors & Collaborators

  • Karol Palwel Budohoski

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-05-31
Completion
2017-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02394678 on ClinicalTrials.gov