Thrombolysis Protocol for use in acute stroke
AIM – ARRIVAL TO DRUG ADMINISTRATION ≤ 30 minutes
NAME ONSET Date Lysis team called at
ONSET Time Bloods taken at
D.O.B. ADMISSION Date
HOSP. No ADMISSION Time
ON ARRIVAL TO A&E /MAU
If approximate onset time is 1.4
Stop infusion if any evidence of bleeding, if neuro signs deteriorate of if there is a massive increase in BP.
Complete treatment record, assessments, NIHSS, Rankin, Barthel on page 4 and SITS register form.
Admit to the Acute Stroke Unit
Hand over thrombolysis care plan to ward staff
Inform the thrombolysis phone holder on call of patient if lysis was done by a doctor in A&E
Check that the following information has been recorded in the patients notes:
Names(s) of the Doctors responsible for reading C.T. Scan
Dosage of rtPA given
File original of this in the notes and send copy to Dr C. Roffe for SITS register
REMEMBER if out of time for therapeutic thrombolysis, rTPA can be given as part of the IST-3 trial up
to 6 h after symptom onset, or up to 9 hours as part of DIAS-4 (working hours only).
Thrombolysis pathway and docs Christine.roffe@northstaffs.nhs.uk 24 03 2011 adapted from a pathway provided by G. Ford 1 of 7
BODY WEIGHT/DOSE CHART FOR rtPA DRUG DOSAGE AND
(Alteplase) ADMINISTRATION
Body Body Total 10% 90% IV No. of PATIENTS MUST BE
Weight Weight rtPA Bolus Infusion 50mg CONTINUOUSLY MONITORED
(Stones) (Kg) Dose (ml) (ml/hr) rtPA PRIOR TO AND DURING DRUG
(mg) vials ADMINISTRATION, and for at least 24
needed hours following administration.
6st 4 40 36 4 32 1
6st 8 42 38 4 34 1
7st 44 40 4 36 1 1. Total dose: 0.9mg/kg.
7st 3 46 41 4 37 1 MAXIMUM DOSE IS 90 MG.
(See body weight/dose chart)
7st 7 48 43 4 39 1
7st 12 50 45 5 40 1 2. Should be prescribed by, and
8st 2 52 47 5 42 1 administration supervised by, a
8st 6 54 49 5 44 1 Doctor from the stroke team.
8st 12 56 50 5 45 2
9st 1 58 52 5 47 2 3. 10% of total dose given as an
9st 6 60 54 5 49 2 I.V. push over 2 minutes by a
9st 10 62 56 6 50 2 Doctor from the stroke team.
10st 64 58 6 52 2 4. Give remaining 90% of dose
10st 5 66 59 6 53 2 I.V. over 60 minutes via infusion
10st 9 68 61 6 55 2 pump.
11st 70 63 6 57 2
11st 4 72 65 6 59 2 5. Observe patient for any
11st 9 74 67 7 60 2 deterioration during infusion.
12st 76 68 7 61 2
12st 3 78 70 7 63 2
12st 8 80 72 7 65 2
12st 12 82 74 7 67 2
13st 3 84 76 8 68 2
13st 7 86 77 8 69 2
13st 12 88 79 8 71 2
14st 90 81 8 73 2
14st 6 92 83 8 75 2
14st 11 94 85 8 77 2
15st 2 96 86 9 77 2
15st 7 98 88 9 79 2
15st 10 100 90 9 81 2
Thrombolysis pathway and docs Christine.roffe@northstaffs.nhs.uk 24 03 2011 adapted from a pathway provided by G. Ford 2 of 7
INCLUSION CRITERIA
ANSWER TO THE FOLLOWING QUESTIONS MUST BE YES YES NO
Intracranial haemorrhage excluded by CT head scan
Onset of symptoms less than 3 h ago (may extend to 4.5 h if thrombolysis consultant agrees)
Previously independent
Verbal or written informed consent or assent
EXCLUSION CRITERIA
ANSWER TO ALL OF THE FOLLOWING QUESTIONS MUST BE NO YES NO
Uncontrolled hypertension (systolic >185mmHg or diastolic >110mmHg)*
BP,
BM
Blood glucose 22 mmol/l*
Coma
Seizure at stroke onset*
Stroke within the preceding 3 months*
Rapidly resolving symptoms*
Head injury at the time of stroke or within the preceding 3 months*
CNS exclusions
H/O intracranial haemorrhage (e.g. SAH, SDH, ICH) any time in the past*
Symptoms suggestive of SAH even if CT normal)*
Non-ischaemic pathology (e.g. functional, migraine, brain tumour, septic embolus etc
likely)*
Any history of CNS damage (AVM, neoplasm, intracranial or spinal surgery)
Potential source of GI bleed (colitis, liver disease, pancreatitis, oesophageal varices,
active peptic ulcer disease)*
Endocarditis, pericarditis, recent MI, aortic aneurysm or ventricular aneurysm
Other sources of
Trauma with fracture or internal injuries within previous 4 weeks
Surgery or visceral biopsy, cardiopulmonary resuscitation within previous 4 weeks or
bleeding
arterial or lumbar puncture within 7 days)*
Pregnancy, or childbirth within the previous 4 weeks or breastfeeding
Haemorrhagic retinopathy (e.g. untreated proliferative diabetic retinopathy)
On warfarin, heparin or equivalent anticoagulation (unless INR 3 hrs (consider IST-3 up to 6 h and DIAS-4 up to 8h)
Age>80 (consider IST-3)
N.I.H. Score ≤ 4 or >=25 (consider IST-3)
Fixed head or eye deviation (relative contraindication, consider IST-3) b
Others
Hypodensity or sulcal effacement in >1/3 of MCA territory (relative contraindication,
consider IST-3) b
Brain stem stroke: i.a. thrombolysis may be considered even in unconscious patients,
Intraarteri
and delivered up to 12 h after symptom onset if there is basilar artery occlusion.
al lysis
Do CT angiogram and conisder ia thrombolysis if hyperdense MCA, age<75 and fit for
GA, time form onset 3-6h in ant circ stroke or in brain stem stroke (see pathway for
ia thrombolysis on www.thrombolysis.info)
This list includes all exclusions given in the product license. *exclusions also listed in NIH trial
Relative contraindications are those mentioned in SITS-MOST protocol, but not in the NIH trial
a
If there is no clinical reason whatsoever to suspect an abnormal FBC or INR thrombolysis should not be delayed
b
to wait for the results. exclusion in SITS, but not in product license or in NIH trial
Thrombolysis pathway and docs Christine.roffe@northstaffs.nhs.uk 24 03 2011 adapted from a pathway provided by G. Ford 3 of 7
SITS No Name:
Unit No:
Date of lysis
Thrombolysis Log and Follow-up
For SITS/ SINAP/ AUDIT
C.T. read by Comments/ Details:
Decision to lyse made by (name)
Grade of decision maker
(F2 SpR SG Cons SRN ConsN)
Specialty of decision maker
(A&E, stroke, neuro, other)
Thormbolysis decision supported by stroke
specialist (give name):
In person/ via phone/ phone w CT link / via videolink
Stroke/ Thrombolysis specialist consulted
(give name or say no )
Mode of specialist consultation
(in person/ phone/ Phone with CT link/
videolink/ none/ other )
Body wt (known/ estimate)
Dosage Bolus
Dosage Infusion
Dosage total
Thrombolysis start time
Thrombolysis completion time
Excluded (give reason in comments box )
No Anticoagulants or antithrombotics to be
given for 24 h documented on drug chart
Care plan handed over to ward staff
Assessments Baseline After lysis 24h 1 week or DC if
(1h-2h) earlier
Date+time
NIHSS
Blood Pressure x
Complications/ adverse Yes /no Yes /no Y N
Angiooedema
events (if yes specify) Symptomat. Brain Haemorrh.
Extracranial Haemorrhage
Other
CT head scan 0 hrs 24-48 h Other
Date and time
Result
6 weeks 3 months
Follow-up Discharge
(clinic) (phone)
Date
Rankin
NIHSS See above
Thrombolysis pathway and docs Christine.roffe@northstaffs.nhs.uk 24 03 2011 adapted from a pathway provided by G. Ford 4 of 7
Nursing Care Pathway for thrombolysis (adapted from IST-3 Website)
Prepare for arrival of patient to ward
Minimum equipment required:
O2 and O2 saturation monitor
Suction
Drip stand
Syringe pump and attachments
Manual sphygmomanometer
On arrival of patient – record
GCS
BP, Pulse, T, Pulse
O2 saturation
Next:
Initial bolus of treatment given by doctor over 1-2 minutes
Remainder of treatment to be given by syringe driver over 1 hour
Record GCS and vital signs:
Every 15 minutes for 2 hours
Every 30 minutes for the next 6 hours
Hourly for a further 6 hours
4 hourly for the next 36 hours
IF THERE ARE ANY SIGNS OF BLEEDING OR THE PATIENT DETERIORATES IN ANY
WAY CALL THE SENIOR NURSE IN CHARGE AND THE RESPONSIBLE MEDICAL TEAM
and
inform Thrombolysis consultant on call
Management of complications is outlined in the thrombolysis training folder or can be
downloaded from www.thrombolysis.info
Thrombolysis pathway and docs Christine.roffe@northstaffs.nhs.uk 24 03 2011 adapted from a pathway provided by G. Ford 5 of 7
In the 24 hours following treatment avoid:
Urinary catheterisation
NG insertion
Central venous access
Anticoagulation
im injections (for 48 hrs)
Aspirin until 24 h post treatment CT scan results available
If essential discuss with thrombolysis consultant on call
Additional instructions for patients who have had intra-arterial
thrombolysis
Check femoral catheter for bleeding during each observation
(schedule as above)
Do not mobilize out of bed until 4 h after catheter removed
Catheter should be removed by a trained person 24 h after the end
of lysis. Site must be compressed manually for at least 20 min after
catheter removal (follow instructions of operator)
If the patient has a urinary catheter remove this 24 h after the end of
lysis (unless this is a permanent indwelling catheter)
Thrombolysis pathway and docs Christine.roffe@northstaffs.nhs.uk 24 03 2011 adapted from a pathway provided by G. Ford 6 of 7
Patient Information Leaflet.
Thrombolysis (treatment with a clot dissolving drug – alteplase) for acute stroke
Your doctor and the medical staff looking after you have decided that your symptoms
are caused by a blood clot blocking one of the vessels that supplies blood to part of
your brain. This may result in a disabling stroke unless the blood supply is restored to
the part of your brain that is affected.
Alteplase is a drug which is routinely used in the treatment of heart attacks. It has also
been shown to be effective in the treatment of acute stroke. This is best if the
treatment is started within 3 hours of the stroke starting. Alteplase breaks down blood
clots and this is why it is used in some strokes. The aim is to try and get the blood
flowing back into the affected area of the brain. This treatment has been checked and
approved by regulatory authorities in Europe and Great Britain (NICE.)
Aleplase does not always make the blood clot go away because they vary in size and
what they are made of. Giving you alteplase can cause bleeding in the brain. This can
be serious and lead to worsening in your condition and death. Nevertheless, alteplase
is a very good treatment that may make your condition better or lead to a big
improvement over the next few hours. In trials of this treatment, for every 100 patients
given alteplase, 10 more have improved so much that they have become able to look
after themselves when compared to 100 with no treatment. However, 7 of the 100
patients who had the drug had a bleed into their head.
To make sure that patients get the most benefit and the smallest risk, we need to start
this treatment within 3 hours of the start of your stroke. The drug is given via a ‘drip’
into a vein over one hour. You will be very closely monitored while you are having the
treatment and over the next 24 hours. Otherwise your care will be exactly the same as
it is for all our patients who suffer a stroke. You will have another CT scan (like the
one you have just had) done 22-36 hours after the drug.
To allow us to plan care for future patients, your treatment and its effect will be stored
on a special database. This data will be recorded in such a way that your identity will
not be revealed to anyone outside of the study. The data that we store may be looked
at by scientists and the results published for guiding future treatment and education.
Your identity will not be revealed.
Please contact a member of the team treating you or Dr C Roffe (01782 55 5880) for
any queries.
Thrombolysis pathway and docs Christine.roffe@northstaffs.nhs.uk 24 03 2011 adapted from a pathway provided by G. Ford 7 of 7