MISTIE
Research type
Research Study
Full title
Minimally Invasive Surgery plus rt-PA for ICH Evacuation (MISTIE)
IRAS ID
5898
Sponsor organisation
The Johns Hopkins University
Eudract number
2007-006006-22
ISRCTN Number
NCT00224770
Clinicaltrials.gov Identifier
Research summary
This trial is aimed at treating spontaneous Intracerebral Haemorrhage (ICH). The acronym MISTIE stands for Minimally Invasive Surgery plus injection of recombinant Tissue plasminogen activator (rt-PA, the trial drug) via a catheter inserted into the haematoma to facilitate Intracerebral haemorrhage (ICH) Evacuation (drainage of the haematoma via intracerebral catheter). The study is coordinated by the John Hopkins University Coordinating Centre (USA) and is a multi-centre international study. This study is investigating the removal of blood from the brain following spontaneous or non-traumatic bleeding. Intracerebral Haemorrhage (ICH) is bleeding into the brain occurring in patients with high blood pressure or in the elderly due to fragile blood vessels. Death rates in these patients are high and recovery rates are poor in survivors despite best medical treatment. It has been shown that the size of the blood clot in the brain is related to recovery. Removal of the clot by surgery can however sometimes be as harmful. Recent studies have shown that less aggressive methods of blood clot removal, such as endoscopic surgery or inserting a drain into the clot and giving clot busting medicines may be of more benefit and less risky. This study will enable us to determine if a clot busting drug called rt-PA (Activase) or endoscopic treatment is safer than current methods of medical treatment. rt-PA will be used in combination with minimal surgery. This drug is already approved by the US Food and Drug Administration for use as a clot buster in heart attacks or stroke. Patients taking part in the study will either receive surgical drainage of the clot plus a series of rt-PA injections into it or the currently used method of medical treatment for this type of bleeding. All patients will be followed up for a period of 6 months to monitor their progress.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
08/H0906/158
Date of REC Opinion
14 Jan 2009
REC opinion
Further Information Favourable Opinion