Authors: Rob Hirst, Liz Farah, Becky Maxwell, Chris Connolly, Dave McCreary, Andy Neill / Codes: NeuC11, NeuP3, PalC4, SLO10 / Published: 02/12/2024

Authors

  • Andy Neill
  • Dave McCreary

Clinical Question

  • Does removing clot in ICH help?

Title

  • Pradilla, G. et al. Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage. N. Engl. J. Med. 390, 1277–1289 (2024).

Background

  • We see a lot of spontaneous ICH. Typically from hypertension or cerebral amyloid angiopathy. We refer them all to neurosurgery as a routine but the neurosurgeons typically have little to offer them. The exception of course is posterior fossa bleeds where like the x wings entering the death star "you can rund out of space real fast".
  • given that we know blood squeezing brain tissue is generally a bad thing it seems reasonable to try and remove the blood. The new kid on the block with this in minimally invasive clot removal. A sort of key hole surgery type suction device for the brain.
  • it involves a small burr hole and then inserting the aspiration device. Given the issues with surgical access it's used mainly for the more superficial bleeds.
  • this paper looks at that

Methods

  • prospective multi centre randomised trial which all sounds good to start with but the whole trial itself was sponsored by the device manufacturer.
  • included if in a study centre (where the surgeons had been trained by the device maker) with 30-80mls of blood supratentorially with GCS 5-14 and an NIHSS more than 5. Had to be done in first 24 hrs
  • outcome was a modified rankin score at 6 months. This is done in person or via phone questionnaire and is a common outcome in stroke and neuro trials.

Results

  • screened 11000 and recruited 300 so gives you an idea of how broadly applicable it might be
  • haematoma volume decreased from 75 to 15mls post surgery.
  • mortality was 18% vs 9% favouring the surgery group
  • they report a +ve primary outcome but they use something called the utility weighted mRS. I found this a little dense but it does seem to be well established. It seems to give the 6 different mRS categories different weights or importances based on how patients perceive quality of life. Apparently this improves statistical power. It may all be hocus pocus but it is definitely beyond me.
  • if you look at figure 2 which is a nice little ladder diagram type thing, the classic way to present the mRS, it makes surgery look like a better choice. for example at the better end of the scale mRS 1 was 21% vs 9%, mRS 2 was 22 vs 15%

Thoughts

  • the trial is plagued by being device sponsored and super selective. Would need to be repeated to convince me it's robust.
  • the mortality figure is interesting but given the lack of blinding (people know when they've had a hold drilled in their hole) that may well affect decisions about WOLST if you really believe in the intervention.

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