Rheolytic Thrombectomy For Adult Intraventricular Haemorrhage (rtIVH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02394678|
Recruitment Status : Unknown
Verified April 2015 by Karol Palwel Budohoski, Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was: Not yet recruiting
First Posted : March 20, 2015
Last Update Posted : April 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Intraventricular Hemorrhage||Device: AngioJet Thrombectomy System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rheolytic Thrombectomy For Adult Intraventricular Haemorrhage|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||May 2017|
Experimental: Intervention - clot removal
Patients will undergo rheolytic thrombectomy for intraventricular hemorrhage
Device: AngioJet Thrombectomy System
Mechanical removal of blood, using a pressurised jet of water, from ventricles of patients suffering from intraventricular haemorrhage
- Clearance of intraventricular blood measured on computed tomography [ Time Frame: 96 hours ]
- 14-day survival [ Time Frame: 14 days ]
- Modified Rankin Score at 6 months [ Time Frame: 6 months ]
- Duration of External Ventricular Drainage [ Time Frame: 30 days ]
- Permanent CSF diversion [ Time Frame: 2 years ]
- Intra- or post-operative rebleeding [ Time Frame: 96 hours ]
- Culture-proven CNS infection [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394678
|Contact: Karol P Budohoski, MD, PhDemail@example.com|
|Contact: Peter J Kirkpatrick, FRCS(SN)||firstname.lastname@example.org|