RIGHT Trial

• Research type

  Research Study

• Full title

  Determining the potential of ambulance-based randomised controlled trials in patients with hyperacute stroke; assessment of GTN in lowering blood pressure

• Contact name

  Phillip Bath

• Sponsor organisation

  University of Nottingham

• Eudract number

  2007-004766-40

• ISRCTN Number

  ISRCTN66434824

• Research summary

  Stroke is a devastating disease affecting about 120,000 people in the UK alone each year. While it is important to try and prevent strokes from occurring, it is becoming clear that if action is taken early after the onset of a stroke, death and disability can be prevented. There are already new drugs available for stroke that can reduce death and disability if given early and more drugs are currently being developed. These new treatments work on the premise that in the first few hours after stroke onset, some brain tissue is still alive and salvageable but in danger of permanent damage. By the time a patient reaches hospital, the usual site for recruitment and treatment in acute stroke trials, these hours are often past. Involving the ambulance service in the identification of suitable patients, randomising and then administering these treatments may allow new interventions reatments for acute stroke to be tested more successfully in ultra acute stroke.In this study we aim to test whether the ambulance service is able to correctly identify acute stroke patients and randomise them to a treatment prior to their transfer to an acute stroke unit.Patients with probable stroke within four hours of onset and high blood pressure (BP) are recruited into the study by paramedics after initial consent is obtained. They will then randomly assign them to treatment with a BP lowering drug (glyceryl trinitrate) or none with blinding provided by a plain gauze dressing. In hospital, further informed consent is taken by the research staff to continue assessment and treatment for 7 days. Hospital assessment will include BP and stroke disability monitoring in addition to a blood test. Patients will have a final follow ??up at 90 days after entry into the study.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  09/H0408/5

• Date of REC Opinion

  8 Apr 2009

• REC opinion

  Further Information Favourable Opinion