Thrombolysis
in acute stroke is an important intervention in a small number of
patients. It is likely even with a very active and experienced centre
only about 10% of patients will fulfill the criteria for thrombolysis.
Whilst
the figures from the
NEJM
NINDS rT-PA Study Group were
promising the treatment has not responded well to attempts to
expand the indications and step outside the rigid protocols currently
in place.
NICE have recently come out in favour of
alteplase within 3 hours in acute ischaemic stroke. All UK centres
should be registered nationally for monitoring purposes and the
treatment delivered by physicians with an interest in stroke.
The research on from
which the current protocols were developed are available for
downloading on the right hand side of this page. In addition
the Safe Implementation of Thrombolysis in Stroke (SITS) have a
protocol which is also available for your information.
Straying
outside of the protocols tends to lead to an increase in the cerebral
haemmorhage rate and therefore an increase in the mortality.
IST3 is currently running and will show whether extending the
window of oppurtunity from 3 to 6 hours post event is beneficial.
As
a quick visible guide below are the current inclusion and exclusion
criteria as per the SITS protocol. Local implementation may
vary so please consult your own department.
Inclusion
Criteria- Female or male
inpatients
- Age 18
– 80 years
- Clinical diagnosis of
ischaemic stroke
causing a measurable neurological deficit defined as
impairment of language, motor function, cognition, gaze, vision and/or
neglect.
- Ischaemic
stroke is defined as an event characterised by sudden onset of acute
focal neurological
deficit, presumed to be caused by cerebral ischaemia, after CT scan
exclusion of
haemorrhage
- Onset of symptoms within 3 hours prior
to
initiation of thrombolysis treatment
- Stroke symptoms present for at least 30 minutes
and has not
significantly improved before
treatment. Symptoms must be distinguishable from an episode of
generalized ischaemia
(i.e. syncope), seizure, or migraine disorder
- Patients
are
willing to receive thrombolysis treatment and to give informed consent
with
regard to retrieval of data and follow up procedures, according to the
regulations in
participating countries
- Willingness and ability to
comply with
the study protocol
Exclusion
CriteriaThe cerebral CT exclusion
criteria are:
- Evidence of intracranial
haemorrhage (ICH) on the CT-scan
The general
exclusion criteria are:
- Symptoms of
ischaemic attack began more than 3 hours prior to infusion start or
when time of symptom onset is unknown
- Minor
neurological deficit or symptoms rapidly improving before start of
infusion.
- Severe stroke as assessed clinically
(e.g. NIHSS>25) and/or by appropriate
imaging techniques
- Seizure at onset of stroke
- Symptoms
suggestive of subarachnoid haemorrhage, even if the CT-scan is
normal
- Administration of heparin within the
previous 48 hours and a thromboplastin time
exceeding the upper limit of normal for laboratory
- Patients
with any history of prior stroke and concomitant diabetes
- Prior
stroke within the last 3 months
- Platelet count of
below 100,000/mm3
- Systolic blood pressure
>185 mmHg or diastolic blood pressure
>110 mmHg, or aggressive management (IV medication) necessary to
reduce BP
to these limits.
- Blood glucose <50 or
> 400 mg/dl.
- Known haemorrhagic diathesis
- Patients
receiving oral anticoagulants, e.g. warfarin sodium
- Manifest
or recent severe or dangerous bleeding
- Known
history of or suspected intracranial haemorrhage
- Suspected
subarachnoid haemorrhage or condition after subarachnoid
haemorrhage from aneurysm
- Any history of central
nervous system damage (i.e. neoplasm, aneurysm,
intracranial or spinal surgery)
- Haemorrhagic
retinopathy,e.g. in diabetes (vision disturbances may indicate
haemorrhagic retinopathy)
- Recent (less than 10
days) traumatic external heart massage, obstetrical delivery,
recent puncture of a non-compressible blood-vessel (e.g. subclavian or
jugular
vein puncture
- Bacterial endocarditis, pericarditis
- Acute
pancreatitis
- Documented ulcerative gastrointestinal
disease during the last 3 months,
oesophageal varices, arterial- aneurysm, arterial/venous malformation
- Neoplasm
with increased bleeding risk
- Severe liver disease,
including hepatic failure, cirrhosis, portal hypertension
oesophageal varices) and active hepatitis
- Major
surgery or significant trauma in past 3 months