INFLAME-ICH: pilot study

• Research type

  Research Study

• Full title

  INFLammation After Minimally invasive Evacuation of IntraCerebral Haemorrhage: pilot study (INFLAME)

• IRAS ID

  163606

• Contact name

  Adrian Parry-Jones

• Contact email

  adrian.parry-jones@manchester.ac.uk

• Sponsor organisation

  University of Manchester

• Duration of Study in the UK

  0 years, 9 months, 30 days

• Research summary

  This is a pilot study designed to refine our procedures for measuring levels of inflammation in the brain after a brain haemorrhage (intracerebral haemorrhage; ICH). We know from previous studies of ICH that high levels of inflammation in the blood leads to a worse recovery but in order to prove if reducing inflammation will lead to patient benefit; we need to better understand its effect within the brain.
  After ICH, patients are admitted to a specialist neurosurgical centre for treatment. This may include an operation to remove the blood clot or drug treatment to reduce the pressure within the brain.

  There have been few new treatments for ICH in the last 30 years but a research team, based in America, is conducting a clinical trial which will give a clot-busting drug recombinant tissue plasminogen activator (rt-PA) directly into the blood clot within the brain via a small tube (catheter) inserted during surgery. The drug, rt-PA will be administered every 8 hours for up to 3 days after the ICH. The catheter is connected to a chamber which collects the haematoma fluid and rt-PA. This fluid would otherwise be discarded but accessing this fluid offers us the opportunity to measure levels of inflammation in the brain.

  We plan to collect samples of fluid from all patients who have been recruited to the clinical trial (MISTIE III). The fluid would be safely collected by the research team to allow levels of inflammation measured and could inform when and how to target inflammation to improve patient outcome after ICH however, we need to first optimise our collection procedures. This pilot study will therefore include only patients recruited into the MISTIE III study from Salford Royal NHS Foundation Trust where the measurement of inflammation will be conducted.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  14/EE/1205

• Date of REC Opinion

  3 Dec 2014

• REC opinion

  Further Information Favourable Opinion