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2. The Guidance
Contents Page
Reason for change 2
Thrombolysis pathway 3
Clinical Exclusions from thrombolysis 5
Management of hypertension 7
r-tPA dose ready reckoner 8
Consent issues 9
Management of complications after thrombolysis 10
NIH Stroke Scale (full version) 11
ASPECTS score 19
Nursing protocol and care plan 20
References 22
Short NIHSS score sheet 23
Peninsula Heart & Stroke Network Clinical Reference Group 24
statement on thrombolysis
Monitoring and Effectiveness and compliance 27
Governance information 28
Equality Impact Assessment 31
Referral of Patients with Acute Stroke and Proximal Artery Occlusion for
Consideration of Intra-arterial Treatment at Derriford Hospital
Publication of the MR CLEAN; EXTEND-IA; ESCAPE; and SWIFT PRIME thrombectomy trials.
Taken together, these trials provide compelling evidence that quick, early thrombectomy with
second-generation stent retriever devices is safe and effective for reducing disability when used to
treat patients with stroke caused by proximal large artery occlusions in the anterior circulation [2-5].
The NNT for one additional person to achieve functional independence in these trials ranged from
approximately 3 to 7.5.
Referrals only accepted between the hours of 09:00 and 15:00 Monday to Friday.
Possibility of clot extraction within 4.5 hours of stroke (time to groin puncture 4
hours).
Exclusion criteria
Any evidence of haemorrhagic transformation (or primary haemorrhage)
Age greater than 80
Hypodensity involving more than 1/3 of middle cerebral artery territory
Opinion of receiving clinician that clot extraction will be impossible in the required time
How to proceed:
ED consultant discusses patient with stroke consultant on Phoenix (ext 2120/via
switch)
ED consultant contacts Derriford team once CTA images uploaded and arranges
urgent transfer to Derriford hospital.
PRE-HOSPITAL
Stroke eligible for thrombolysis:
Positive FAST (Face, Arm and Speech Test)
Age 18 or older
Symptoms noted on waking exclude thrombolysis
Symptom onset to thrombolysis within 6h
No seizure at onset
Check BM, confirm time of onset, transport to ED RCHT, with NOK and list of pills if
available. Pre-alert ED ensure name, DOB and AFFECTED SIDE included
EMERGENCY DEPARTMENT
Confirm stroke using ROSIER scale
Book CT on MAXIMS ensure side affected is clear on request
Ring 4444 to alert radiographer/stroke nurse/stroke ward
Transport patient straight to CT on arrival for urgent CT head
Brief medical history to confirm time of onset, inclusion and exclusion criteria
Perform NIHSS examination (National Institute Health Stroke Scale)
Brief general examination, estimate weight
BP both arms, repeat higher arm BP after 15 minutes (manual cuff not dynamap)
Manage high BP as per protocol
iv access x2
Urgent bloods = FBC, U&E, clotting, G&S (INR if on warfarin), lipids, glucose
ECG (and CXR if needed)
CT SCANNER
Radiographer performs scan and informs on call radiologist to report scan using
ASPECTS score
AT 12 HOURS
Arrange transfer to Phoenix via clinical site coordinator (bleep 2634)
AT 24 HOURS
Repeat routine CT scan and repeat NIHSS at 24h
Start antiplatelet as per protocol if no bleeding on repeat CT
YES NO
FROM THE HISTORY
ANTICOAGULANTS
Current warfarin treatment is not exclusion if the INR is 1.7 or less.
Current heparin treatment is not an exclusion if the APTT ratio is less than 1.2
Full dose (but not low dose/prophylactic) LMWH is an exclusion
Rivaroxaban/Dabigatran if a patient is on these treatments, 24h or 12h respectively
should elapse before a parenteral anticoagulant is given. This excludes these patients
from thrombolysis for stroke.
PREGNANCY
Pregnancy or women who are post-partum r-tPa is unlicensed for use in pregnancy.
It should not be withheld in pregnant patients with ischaemic stroke, but because
experience is limited, risks and benefits must be carefully weighed and should be
discussed with on-call obstetrician
CHEMOTHERAPY
Some chemotherapy agents may be relative contra-indications to thrombolysis. Or
patients may be cytopaenic. If patient on chemotherapy drugs please ensure bloods
normal first and check with oncology or haematology before giving lysis
CHILDREN
Alteplase is not licensed for <18y. Studies are ongoing in children. Cases should be
discussed by paediatric team with paediatric neurologists at Bristol.
YES NO
ON LAB RESULTS
Platelets <100 (only wait for FBC if known haematological
disorder or on chemo)
Current warfarin treatment with INR MORE THAN 1.7
Do not start treatment until INR available
Current heparin treatment and APTT > 1.2
Do not start treatment until APTT available
Current treatment with full dose LMWH
Plasma glucose <2.7 (Treat as per Trust protocol)
ON CT SCAN reported by radiologist
SIGNATURE
Blood Pressure < 180 Monitor BP, do not intervene, Thrombolyse if eligible
Systolic <105 Diastolic
Systolic >180
And/or *Give IV Labetalol 10 mg iv over 1-2 minutes
Diastolic >105 mmHg Repeat same or double dose to bring BP down to 180/105
Or Labetalol Infusion 2-8mg/min
*If more than 2 doses of labetolol needed Patient NOT eligible for Thrombolysis
In asthma, cardiac failure or 1st Degree heart block use Isoket infusion (2-10mmHg /hr)
Unless the patient or companion knows their recent weight, estimate it to the
nearest 5 kg
The total dose of rt-PA is 0.9 mg/kg or 90 mg, whichever is the lesser (Column 3)
Make up one or two vials of rt-PA using the 50 ml diluent in each drug pack, making
a solution of 1 mg/ml rt-PA
Draw up and give 10% as a bolus over 1-2 minutes (Column 4), using a 10 ml
syringe
Draw up the remaining 90% (the infusion dose, Column 5) into 1 or 2 50ml
syringes and set up the 50ml syringe driver (IVAC) with the corresponding infusion
rate in mls/hr. This infusion is given over 1h.
Do not give the cardiac dose
Do not give more than 90 mg
1 2 3 4 5
45 7 st 1 lb 4 36 40
One
50 7 st 12 lb 5 40 45
vial
55 8 st 9 lb 5 44 49
60 9 st 6 lb 5 49 54
65 10 st 3 lb 6 52 58
70 11 st 0 lb 6 57 63
75 11 st 11 lb 7 60 67
Two 80 12 st 8 lb 7 65 72
vials
85 13 st 5 lb 7 69 76
90 14 st 2 lb 8 73 81
95 14 st 13 lb 8 77 85
100 15 st 10 lb 9 81 90
Thrombolysis with r-tPA is a licensed treatment for acute ischaemic stroke, so written
consent is not required. If possible there should be agreement from the patient and / or
relative.
When the patient cannot agree because of their impairments and no relative is available,
then treatment can still be given if it is judged to be in the best interests of the patient. Any
explanation might include:
There has been a significant stroke caused by a blocked artery preventing blood
from getting to a part of the brain and causing permanent damage. With or without
treatment there may be some recovery or things could get worse. Stroke is fatal in
about a third of people.
Only one treatment has been shown to prevent damage to the brain. This treatment
dissolves the blood clot blocking the artery and allows blood to get back to the brain.
It only works if given quickly after the stroke starting and the benefit is greater the
sooner it is given
There is a slight increased risk of death within the first week (8.9 vs 6.4%), mostly
due to fatal intracranial bleeding (3.6 vs 0.6%). But after the first week there is a
lower chance of death (11.5 vs 13.6%), so several months later there is no
difference in chance of death overall.
The chances of being alive and independent (Rankin score 0-2) several months later
are higher,
% chance of % chance of Absolute benefit
being alive and being alive and number of extra
independent at 3 independent at patients alive and
months if lysed 3 months if not independent at 3
lysed months per 1000
patients treated
if treated within 3h 40.7% 31.7% 90
BP commonly drops after initiation of thrombolysis, not necessarily due to bleeding. If this
happens give iv fluid bolus.
Bleeding, by process of de-fibrination, is more common than with heparin (around 3%)
Intracranial bleeding
Should be suspected if there is neurological deterioration, new headache, fall in conscious
level, acute hypertension, seizure, nausea or vomiting
Initial action
Stop infusion of r-tPA, repeat NIHSS, commence iv saline if needed
Arrange urgent CT scan
Check FBC, full coagulation screen, check blood sent for G&S
Is haemorrhage parenchymal?
Give 20% mannitol 200ml stat (dose may be repeated)
Consider tranexamic acid 10 mg/kg IV and 10 units cryoprecipitate
Further advice is available via the intranet anti-coagulation guidelines and Consultant
Haematologist
Extracranial bleeding
Should be suspected if there is shock, drop in BP, evidence of blood loss although a
high index of suspicion is needed as blood loss may not be obvious.
Initial action
Stop infusion of r-tPA
Check FBC, full coagulation screen, check blood sent for G&S and/or arrange cross match
depending on situation
Commence iv saline or blood transfusion depending on situation
If patient fails to respond to simple measures or there is severe haemorrhage, consider
tranexamic acid 10 mg/kg IV and 10 units cryoprecipitate
Further advice is available from intranet, on call geriatrician and haematologist as above.
Anaphylaxis
Anaphylactic reactions to r-tPA can occur but are rare. If an urticarial rash, peri-orbital
swelling or tongue swelling occur, the r-tPA should be stopped and the patient reviewed by
a doctor urgently.
This is a topographic score for dividing middle cerebral artery territory into 10 regions. It is
calculated from 2 standard axial CT cuts, one at the level of the basal ganglia and one at
the corona radiate / centrum semiovale level. Subcortical structures are allotted 3 points
and cortical structures 7 points.
For each of these 10 areas a point is subtracted if there is evidence of ischemic damage
there (eg reduced attenuation, loss of grey-white matter differentiation, focal swelling).
A scan with no ischaemia in the MCA territory would score 10 and a scan with diffuse
involvement of all MCA territory would score 0.
An ASPECTS score 7 or less is a relative contra-indication to thrombolysis, with increased
risk of haemorrhage; in this instance consider carefully other factors that may influence the
decision to treat or not to treat
5. If there are any concerns, medical review is essential. Report, review, document and
increase frequency of observations accordingly.
6. Pyrexia > 37C should be treated with PR or PO Paracetamol (1g 4-6 hourly. No more
than 4g in 24 hours)
9. Avoid catheterisation for 24 hours following thrombolysis infusion to minimise the risk of
trauma and bleeding. If essential, consult with medical team.
10. Do not insert naso gastric tubes for 24 hours post thrombolysis infusion to minimise the
risk of trauma and bleeding
11. IM injections should be avoided for 48 hours post thrombolysis infusion to minimise the
risk of excessive bruising
12. Avoid giving heparin / warfarin. Refer to medical staff before commencing any anti
coagulant or antiplatelet therapy (only given if CT at 24h shows no bleeding).
1a. LOC
Score 0-3
1b. LOC Response to Questions
Score 0-2
1c. LOC Response to Commands
Score 0-2
2. Best gaze
Score 0-2
3. Visual fields
Score 0-3
4. Facial palsy
Score 0-3
5. Right Arm motor
Score 0-4 or X if untestable
6. Left Arm motor
Score 0-4 or X if untestable
7. Right Leg motor
Score 0-4 or X if untestable
8. Left leg motor
Score 0-4 or X if untestable
9. Ataxia
Score 0-2 or X if untestable
10. Sensory
Score 0-2
11. Best language
Score 0-3
12. Dysarthria
Score 0-2 or X if untestable
13. Neglect/Inattention
Score 0-2
Total Score (0-42)
Treatment recommendations
Patients with acute basilar artery occlusion should be evaluated in centres with
multimodal imaging and treated with mechanical thrombectomy in addition to
intravenous thrombolysis when indicated (Grade B, Level 2a, KSU Grade C);
alternatively they may be treated within a randomized controlled trial for thrombectomy
approved by the local ethical committee - new
Patient selection
If vessel imaging is not available at baseline, a NIHSS score of 9 within three, and
7 points within six hours may indicate the presence of large vessel occlusion (Grade B,
Level 2a, KSU Grade B) - new.
Patients with radiological signs of large infarcts (for ex. using the ASPECTS score) may
be unsuitable for thrombectomy (Grade B, Level 2a, KSU Grade B) - new
Imaging techniques for determining infarct and penumbra sizes can be used for patient
selection and correlate with functional outcome after mechanical thrombectomy (Grade
B, Level 1b, KSU Grade B) - new.
References
7. NICE Guidance TA 122 - Alteplase for the treatment of acute ischaemic stroke
11. Use of the Alberta Stroke Program Early CT Score (ASPECTS) for Assessing CT
Scans in Patients with Acute Stroke
12. Am J Neuroradiol 2001; 22:153442
17. Campbell BC et al. Endovascular therapy for ischemic stroke with perfusion-
imaging selection. EXTEND-IA Investigators. N Engl J Med. 2015;372(11):1009.
Tool Sentinel Stroke National Audit Programme (SSNAP) from the Royal
College of Physicians
December
V2.0 Amendment to 24/7 service Dr F Harrington
2010
Dr F Harrington
2/10/2015 V5.0 Availability of intraarterial treatment Dr K Adie
A James
All or part of this document can be released under the Freedom of Information
Act 2000
Controlled Document
This document has been created following the Royal Cornwall Hospitals NHS Trust
Policy on Document Production. It should not be altered in any way without the
express permission of the author or their Line Manager.
7. The Impact
Please complete the following table.
Are there concerns that the policy could have differential impact on:
Equality Strands: Yes No Rationale for Assessment / Existing Evidence
Age Removal of upper age limit for stroke thrombolysis based
on recent randomised controlled trials
Sex (male, female, trans-
gender / gender
reassignment)
Race / Ethnic
communities /groups
Sexual Orientation,
Bisexual, Gay, heterosexual,
Lesbian
You will need to continue to a full Equality Impact Assessment if the following have been
highlighted:
You have ticked Yes in any column above and
No consultation or evidence of there being consultation- this excludes any policies
which have been identified as not requiring consultation. or
Major service redesign or development
8. Please indicate if a full equality analysis is recommended. Yes No
9. If you are not recommending a Full Impact assessment please explain why.
Signature of policy developer / lead manager / director Date of completion and submission
Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead,
c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa,
Truro, Cornwall, TR1 3HD
Signed _______________
Date ________________