Rheolytic Thrombectomy For Adult Intraventricular Haemorrhage
rtIVH
1 other identifier
interventional
20
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2015
CompletedFirst Posted
Study publicly available on registry
March 20, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedApril 6, 2015
April 1, 2015
2 years
March 12, 2015
April 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Clearance of intraventricular blood measured on computed tomography
96 hours
Secondary Outcomes (6)
14-day survival
14 days
Modified Rankin Score at 6 months
6 months
Duration of External Ventricular Drainage
30 days
Permanent CSF diversion
2 years
Intra- or post-operative rebleeding
96 hours
- +1 more secondary outcomes
Study Arms (1)
Intervention - clot removal
EXPERIMENTALPatients will undergo rheolytic thrombectomy for intraventricular hemorrhage
Interventions
Mechanical removal of blood, using a pressurised jet of water, from ventricles of patients suffering from intraventricular haemorrhage
Eligibility Criteria
You may qualify if:
- Age \> 18
- Coma at presentation (i.e. Glasgow Coma Score \<9)
- At least 50% of lateral ventricles cast with blood
- Evidence of hydrocephalus or raised intracranial pressure and External Ventricular Drainage Indicated
- Surgery possible within 48 hours of ictus
You may not qualify if:
- Fixed and dilated pupils at presentation
- Uncorrectable coagulopathy or thrombocytopenia
- Aneurysm or arteriovenous malformation proven or suspected as the source of haemorrhage
- Large, predominant intracerebral haematoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Academic Clinical Fellow, Neurosurgery
Study Record Dates
First Submitted
March 12, 2015
First Posted
March 20, 2015
Study Start
May 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
April 6, 2015
Record last verified: 2015-04