Haemorrhagic strokes represent about 10-15 % of all strokes and 30,000 cases per year in
France. The 30-day death rate ranges from 30 to 55% (50% of deaths occurring within 48
hours). Currently, no urgent medical or surgical treatment has been shown to improve
functional or vital prognosis. Clinical epileptic seizures frequency in acute intracerebral
haemorrhage has been estimated between 4% and 16% but the occurrence of subclinical epileptic
seizures (detected on the electroencephalogram (EEG) only) could be much more frequent (28 %
to 40 %).
Some studies have suggested that early repeated epileptic seizures may be associated with a
worse neurological prognosis. Repeated epileptic seizures occurring in the acute phase may
increase brain oedema, worsen, hypoxia and may lead to cellular death in the injured brain
tissue. Thus, prevention of early epileptic seizures may improve neurological outcome.
However, the efficacy of a systematic prophylactic antiepileptic treatment on clinical and
subclinical epileptic seizures has not been evaluated in the setting of intracerebral
haemorrhage. The current European guidelines recommend the use of antiepileptic drugs only
when epileptic seizures occur.
Primary objective: PEACH is a randomized controlled trial aiming at evaluating the impact of
systematic prophylactic antiepileptic treatment with levetiracetam versus placebo in acute
supratentorial spontaneous intracerebral haemorrhage. The primary endpoint is the occurrence
of at least one clinical or electrical epileptic seizure recorded on continuous 48h holter
Secondary Objectives:This study also aims to assess:
Ä The efficacy of prophylactic treatment with levetiracetam on the number of EEG seizures, on
the total duration of epileptic seizures continuously recorded on EEG, on the occurrence of
some paroxysmal EEG patterns, on the number of clinical seizures occurred during 72 hours of
diagnosis, on the occurrence of early (day-0 to day-30 ) and late (from day-30 to 12 months)
clinical seizures, on the functional prognosis at 3 , 6 and 12 months evaluated by the
modified Rankin scale , on the cerebral oedema and mass effect evaluated by comparing the
admission brain CT scan with the control CT scan performed at 72 hours, on the neurological
status as assessed by the National Institute of Health Stroke Scale at 72 hours , 1 month and
3 months and on the quality of life measured by the Stroke impact Scale at 3, 6 and 12
Ä The frequency of side effects related to treatment with levetiracetam (anxiety and
depression assessed by the Hospital Anxiety and Depression Scale at 1 and 3 months) Sample
Size: 104 patients will be recruited over 2 years.