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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
Sponsor:
Information provided by (Responsible Party):
Karol Palwel Budohoski, Cambridge University Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Intraventricular Hemorrhage Device: AngioJet Thrombectomy System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Clearance of intraventricular blood measured on computed tomography [ Time Frame: 96 hours ]

Secondary Outcome Measures :
  1. 14-day survival [ Time Frame: 14 days ]
  2. Modified Rankin Score at 6 months [ Time Frame: 6 months ]
  3. Duration of External Ventricular Drainage [ Time Frame: 30 days ]
  4. Permanent CSF diversion [ Time Frame: 2 years ]
  5. Intra- or post-operative rebleeding [ Time Frame: 96 hours ]
  6. Culture-proven CNS infection [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Karol P Budohoski, MD, PhD karol.budohoski@gmail.com
Contact: Peter J Kirkpatrick, FRCS(SN) pjk21@medschl.cam.ac.uk

Sponsors and Collaborators
Karol Palwel Budohoski

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Responsible Party: Karol Palwel Budohoski, Academic Clinical Fellow, Neurosurgery, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02394678    
Other Study ID Numbers: A093205
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases