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

    NCT00224770

  • 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