PORTSMOUTH HOSPITALS NHS TRUST

NURSING GUIDELINES

Peripheral Arterial Thrombolysis Guidelines. Issue 2. 04.01.2010

TITLE /
Peripheral Arterial Thrombolysis Guidelines
Manager / committee responsible / DEPARTMENT OF VASCULAR SURGERY, QAH
Date issued / 04.01.2010
Version / 2
Review date / December 2010
Equality impact assessment has been applied to this guideline / C.M BOWNASS (Vascular Nurse Specialist)
Author / C.M. BOWNASS (Vascular Nurse Specialist)
Ratified by /

Professional Advisory Committee – September 2007

Amendments record:
January 2010: This guideline has had its review date extended from June 2008 to December 2010. No other changes other than issue number and issue date.
Contents:
1. Introduction
2. Status
3. Purpose
4. Scope/Audience
5a) Definitions and Indications
5b) Contra-Indications to using alteplase (rt-PA)
6.1Clinical Practice Guideline
6.2Process
7. Supporting Evidence
8. Duties and Responsibilities
9. Training: Competency Statement: Peripheral Arterial Thrombolysis
Appendices:
APPENDIX 1: Information for Patients undergoing Peripheral Arterial Thrombolysis

1. Introduction

Guideline for management of peripheral arterial thrombolysis within the Vascular Unit, QAH

2. Status

Clinical guideline

3. Purpose

The purpose of this guideline is to assist nursing and medical staff, in the use of intra-arterial thrombolysis to obtain safe and effective care for patients.

It is not designed to restrict or limit professional judgement and decision-making. This area of practice will be evaluated and the guideline reviewed whenever there is a change in circumstances or annually.

4. Scope/Audience

This guideline applies to all PHT staff involved in the administration of arterial thrombolysis

5a) Definitions and Indications

ARTERIAL THROMBOLYSIS

Insertion of a catheter under x-ray visionand usually via the femoral artery to infuse fibrinolytic agent – e.g. .Alteplase (i.e rt-PA or Actilyse) directly into an arterial clot (thrombus).

RECOMBITANT TISSUE TYPE PLASMINOGEN ACTIVATOR ALTEPLASE (RT-PA),

rt-PA is a synthetic version of this naturally occurring protein and is potentially fibrin specific, that is, it works only at the site of recent thrombus deposition, rather than having a generalised systemic effect. Other lysis agents include streptokinase, tenecteplase, reteplase but alteplase is currently the only drug in use for arterial thrombolysis in P.H.T.

FIBRINOLYSIS (LYSIS)

This is the dissolution of a blood clot’s fibrin network; it occurs naturally when proteins released by damaged tissues activate the plasma enzyme PLASMINOGEN into the active plasma enzyme PLASMIN.

INDICATIONS FOR INFUSION

Arterial occlusion of recent onset involving native artery, by-pass graft or dialysis access fistula.

The most suitable lesions for lysis are 10-20 cm in length, are acutely occluded, and have good run-off vessels distally.

A common site for lysis is the femoral-popliteal artery. The intra-arterial system is generally comprised of a sheath into e.g. the femoral artery, and a longer arterial catheter inserted via the sheath.

Consultation between radiologist and vascular surgeon re appropriateness of procedure and immediate back up from a vascular surgery team is essential because of the potential complications of lysis. Where possible, lysis is started early in the working day and as a planned procedure.

5b) Relative contra-indications to using rt-PA (Senior medical clinician to determine patient’s suitability for peripheral arterial thrombolysis)

  • Ischaemic neurological abnormality/stroke
  • Severe liver disease, including hepatic failure, oesophageal varices and active hepatitis
  • Recent haemoptysis, G.I. bleed, gross haematuria
  • Coagulation defects
  • Recent surgery/trauma, including dental extractions in past 3 months
  • Severe uncontrolled arterial hypertension
  • Open wounds
  • Recent childbirth
  • Patients receiving oral anti-coagulants e.g. warfarin sodium
  • Neoplasm with increased bleeding risk
  • Bacterial endocarditis

These factors increase the risk of haemorrhage.

Complications of alteplase (rt –PA)

  • Haemorrhage – can be minor e.g. from around the catheter site (approx 40%) or major e.g. a retroperitoneal haematoma (approx. 9% and requiring blood transfusion 1).
  • Cerebral Vascular Accident CVA – (1-2% risk of intra-cranial haemorrhage)
  • Allergy/anaphylaxis
  • Renal Failure
  • Distal emboli (approx 4 % - these may break off from the dispersing thrombus and shower down the limb causing ischaemic pain. Small clots will be dissolved by the continuation of lysis 1)
  • Reperfusion injury (2% - restoring blood flow to ischaemic tissues may lead to systemic inflammatory response and multi-organ dysfunction 1)

6.1 Clinical Practice Guideline

WARD PREPARATION OF PATIENT

Action / Rationale
Preparation as for Trans Femoral Angiogram - see check list
Ward visit by X-Ray nurse /Ward nurse who has completed Peripheral Arterial Thrombolysis Competency to:
meet and assess the patient
explain preparation and procedure
explain the aftercare
answer any questions / 1, 3, 4,
To allay anxiety, assess patient’s ability to tolerate the procedure and provide reassurance
X-ray nurse to supply check list and any specific instructions – e.g. care of diabetics / To promote patient safety
Ward staff and X-ray nurse to ensure that
  • patient’s details are correct
  • clotting studies (I.N.R. and A.P.T.R.) have been requested, are available and are satisfactory
  • blood has been taken for urea & electrolytes, group and save
  • a consent form has been signed by the patient
  • patient has a wide bore IV cannula
/ To ensure all relevant clinical information is available, that the patient is medically stable (renal and coagulation function assessed) and the risk of complications is minimised.
To ensure that the patient understands the procedure and gives valid consent
For I.V. access/analgesia
When peripheral arterial thrombolysis is performed out of hours or is unplanned, it is essential that ward staff are notified as soon as possible. / In order that appropriate arrangements are made for equipment and that transfer to the ward is a safe and smooth process
All peripheral arterial patients should where possible be nursed on E2 (i.e. the vascular ward).
E2 ward must assess and address ward and nursing skill mix in order to provide close supervision of the patient and a safe standard of care. / This is a high risk procedure and nursing staff should be familiar with protocols and potential complications (many other areas nurse peripheral arterial thrombolysis patients on ITUs or HDUs).
PROCEDURE
Action / Rationale
Initially as for T.F.A. i.e.
  • explain procedure and table controls (e.g. table movement)
  • explain and give sedation if appropriate
  • insert wide bore peripheral IV cannula, if not already done
  • prepare and drape skin,
  • give local anaesthetic- usually a femoral approach
/ To reduce anxiety and prepare patient for intensity of procedure and post-procedure care
For administration of IV fluids, as required
To reduce risk of infection
To provide pain relief during procedure
  • incise skin and insert needle
  • insert guide wire
  • remove needle
  • insert introducer sheath
  • insert arterial catheter through sheath
  • remove guide wire

FOR PERIPHERAL ARTERIAL THROMBOLYSIS
Action / Rationale
  • catheter re-positioned until tip is situated proximal to or within thrombus
  • first dose of alteplase (rt-PA) is given in X-ray. Further doses may be given in succession before the patient returns to the ward
  • catheter secured e.g. with suture/opsite
  • light dressing applied
  • Ward staff notified patient is to receive alteplase (rt-PA).
/ To achieve optimal results and maximise concentration of alteplase (rt-PA) in thrombus
To prevent slippage or accidental pulling of the arterial line
To facilitate inspection of the puncture site
To prevent delays in commencement of rt-PA and/or possible occlusion of the lines
  1. Refer to Drug Therapy Guideline)
X-ray nurse to prepare Heparinised Saline. (Unless prescribed otherwise, add heparin 5000 units to 500ml sodium chloride 0.9%). Run this through a volumetric infusion pump. A second volumetric pump will also be required for the alteplase (rt-PA) infusion. / Volumetric pumps improve accuracy of drug administration, i.e. rate, dosage
  1. If sheath in situ, prepare Heparinised Saline (as above), connect to side arm of catheter sheath as marked and set infusion rate (25 ml per hour, unless directed otherwise, refer to Drug Therapy Guidelines).
/ To prevent platelet aggregation/embolus formation along the length of the sheath 3
  1. Prepare alteplase (rt-PA) solution as per prescription and prime infusion set and volumetric pump (refer to Drug Therapy Guidelines)
Label lines as either “Arterial catheter” or “Sheath”
Prior to connection, X-ray nurse should draw back on arterial catheter (via 3-way tap on connecting tube) using a 20 ml syringe.
Connect alteplase (rt-PA) line to main arterial catheter, as marked, and set infusion rate (25 ml per hour, unless directed otherwise and depending on body weight); modify according to instructions.
Have available 10-20 ml sodium chloride 0.9% in a sterile syringe / For easy identification of lines
To ensure line is not blocked and is free of clots.
To flush catheter if line blocks. A sterile syringe is used to minimise risk of introducing infection.
  1. Ensure patient stays on strict bed rest throughout alteplase
(rt-PA) therapy, is nursed flat with only 2 pillows and that there is
minimal moving of patient.
If arterial catheter tip is positioned in arm artery, elevate arm on
pillow; if lower limb use bed cradle
If patient has difficulty with passing urine whilst flat, insert a urinary
catheter. / To prevent dislodgement of arterial sheath and catheter
For comfort and to limit range of movement
To reduce necessity for patient to change position.
  1. Cover catheter entry site with a light gauze dressing, but do
not seal the dressing down.
N.B. the arterial catheter may be on the opposite side to the side
being treated). / To enable continued inspection of line and early recognition of bleeding.
Access from the ipsilateral side may be restricted by previous surgery or the site of the occlusion.
PATIENT’S TRANSFER TO WARD
Action / Rationale
On collecting the patient from Xray, the Ward Nurse & Xray Nurse should check the following:
  • Catheter site
  • Labelling of the Arterial Catheter and Sheath
  • That both Volumetric pumps are working and the drug administered, solution, rate etc
  • All documentation has been completed
  • Any specific instructions noted
and then accompanies patient back to the ward. / To ensure safe hand-over of patient to ward staff
CARE OF THE PATIENT RECEIVING ALTEPLASE rt-PA
Action / Rationale
  1. Patient nursed in OBSERVATIONBAY
/ To allow close observation and monitoring of patient
  1. Assess cardio-vascular function by monitoring patient’s Pulse and
Blood Pressure, Respirations ½ hourly for 4 hours, then hourly if
stable. Record temperature 4 hourly.
Complete MEWS score as per protocol
Observe arterial catheter insertion site hourly for peri –
catheter bleeding, haematoma, line disconnection
Monitor patient for abdominal pain, restlessness, back pain. / To enable deviations (i.e. tachycardia, hypotension,
bleeding, allergic reaction or shock) to be
establishedquickly and complications to be treated
promptly
Bleeding may be visible or concealed causing
e.g. retro-peritoneal haematoma, and occur at
any time during the period of lysis 1
3. If major bleeding does occur, apply firm, direct pressure to puncturesite, discontinue lysis, summon help and treat for shock
as necessary.
If peri-catheter bleeding occurs, apply light gauze dressing and direct, digital pressure.
IF BLEEDING CONTINUES:
  • Contact medical staff
  • Keep patient nil by mouth
/ To control bleeding and prevent formation of
haematoma 3.
Patient may require surgical intervention to
close the puncture site and secure haemostasis
Medical staff will assess need to contact
Interventional Radiologist
4. Monitor patient for other potential bleeding complications, e.g.
intra-cranial (causing strokes), renal tract (causing haematuria)
and GITract (causing oral and/or rectal bleeding). If severe
systemic orintra-cranial bleeding occurs, discontinue peripheral
arterial thrombolysis and seek urgent medical assistance / Distant haemorrhagic complications may
occur due to altered anti-coagulant status 5.
Haemorrhage may be due to lysis of
pre-existing blood clots acting as “plugs”
  1. Check limb/foot hourly as for Trans Femoral Angiogram i.e
warmth, colour, movement, swelling, function and evidence of
embolic “trash” etc.
Mark foot pulses with skin marker and record presence/absence of pulses. / To assess effectiveness of rt-PA, level of action, worsening of ischaemia or compartment syndrome .
Lysis is contra-indicated if there is total limb anaesthaesia, paralysis, swollen or tense muscles or persistent skin discolouration 3
6. Check infusion pump hourly throughout procedure to
ensure pump is running and there is adequate volume of infusion fluid / To ensure infusion runs continuously and there is no back-bleeding
7. Monitor patient’s pain level (see MEWS chart); ensure adequate
analgesia is prescribed and administer as appropriate. Oramorph
or IVmorphine may be indicated and should be titrated to pain. / Clot lysis may cause distal embolisation and
transient pain.
Action / Rationale
8. Administer I.V. fluids as prescribed and maintain an accurate
fluid balance chart / Contrast medium is nephro-toxic, especially in
patients with compromised renal function.
Monitoring diuresis aids with renal assessment 5
9. If patient scheduled for theatre (e.g. for embolectomy) or outcome of
treatment is uncertain, keep nil by mouth, otherwise patient can eat and
drink as desired. / To ensure safe pre-operative preparation of patient
10. If any problems occur, nursing staff should refer to the on call doctor
without delay or directly to senior medical staff as necessary / To ensure help is sought immediately and from the most appropriate staff
11. At pre-arranged interval (e.g. 12-24 hours) and based on clinical
evidence, a repeat angiogram is carried out. / To monitor extent of re-perfusion, to advance the arterial line further into the remaining thrombus or as a basis for surgery 3
12. Exercise caution with administering IM Injections during the period of peripheral arterial thrombolysis and give only under specific medical
instruction. If venepuncture or intra-arterial punctures are necessary, then observe the site for potential bleeding. / Alteplase (rt –PA) affects clotting mechanism and may cause excessive bleeding after venepuncture etc.4
FOLLOWING ALTEPLASE (rt-PA) INFUSION
-Switch off alteplase (rt-PA) infusion as directed by medical staff. Replace alteplase (rt-PA) with heparinised saline (see above) at 25ml/hr
- If sheath in situ, continue proximal infusion of heparinised saline
- Do not remove arterial catheter until consultation with Radiologist. If
patient attends X-ray for repeat angiogram, X-Ray staff may remove
arterial catheter but will leave sheath in situfor removal by the ward staff
(or as per instructions).
-Loosen adhesive dressing over arterial line and withdraw catheter as
instructed through haemostatic valve on the catheter introducer sheath.
Ensure sheath and dressing are still secure
- Do not remove sheath until alteplase rt-PA has been
switched off for one hour
- Check direction of sheath insertion (from notes). Remove stitch /
adhesive dressing.
-When removing sheath, apply manual compression for 10 minutes by
the clock, but do not obliterate the pulse
-Continue to observe the surrounding tissue for bleeding or bulging and
if this occurs apply a further 5 minutes of pressure (more if necessary).
-Apply a light pressure dressing
-Following successful haemostasis- wait at least an hour before
commencing heparin therapy / To prevent platelet aggregation/embolus formation along the length of the arterial catheter 3
N.B. patient may therefore be having heparinised saline via both the sheath and the catheter.
Patient may require further lysis, angioplasty or surgical intervention.
So that sheath is not dislodged until lytic effect is reduced.
Half life of alteplase (rt-PA) is about 5 minutes 3
So that line is removed and pressure applied in appropriate direction
To achieve effective haemostasis whilst ensuring that the distal circulation is not compromised.
Further compression may be needed to ensure bleeding has ceased and to reduce risk of false aneurysm formation.
To enable regular inspection of puncture site
-Do not mobilise the patient for 6 hours following removal of the catheter and then follow protocol for care of patient following Trans-femoral arteriogram
-Commence IV heparin infusion as indicated / To reduce risk of reactionary bleeding from puncture site.
To maintain anti-coagulation

6.2) Process

Prescription and Dose Administration

For preparation and Pharmaceutical Particulars of Alteplase, refer to Drug Therapy Guidelines on PHT Intranet site

Infusions will be prepared by:

  • Radiologist/Doctor
  • Registered nurse / practitioner competent in Intravenous (IV) therapy and competent at Level 3 - 4 of Peripheral Arterial Thrombolysis protocol (see Training and Competency Levels)

Infusions will be set up by:

  • Radiologist/Doctor
  • Registered nurse / practitioner competent in Intravenous (IV) therapy and competent at Level 3 - 4 of protocol

Infusions will be changed by:

  • Radiologist/ Doctor
  • Registered nurse / practitioner competent in Intravenous (IV) therapy and competent at Level 3 - 4 of Peripheral Arterial Thrombolysis protocol

Prior to administration of alteplase (rt-PA) the Radiologist will complete the patient’s prescription chart in relation to the bolus dose and the maintenance dose to be administered on the ward.

The prescription will include: a) drug and concentration b) rate in ml/hour

NB Prescribed settings MUST NOT be altered by ward staff without discussion with the prescribing Radiologist or medical doctor

Alteplase may be re-constituted in x-ray for a bolus dose and the remaining solution returned to the ward, for infusion via volumetric pump

Acute pain can be a common problem with peripheral thrombolysis. Patients should be boarded for analgesia (e.g. Oramorph) prior to the procedure and its effectiveness titrated against their pain.

Peripheral arterial thrombolysis will be stopped when it is clinically safe and appropriate to do so.

Equipment

2 volumetric pumps infusion pumps and giving sets

Any syringes made up by medical or nursing staff should be discarded every 24 hours.

Observations to include

Refer to the MEWS observation record chart; in addition

* Arterial catheter site ½ hourly – for puncture site bleeding, peri-catheter haematoma,

* Limb observations ½ hourly. – for colour, temperature, calf muscle tenderness, function

* Dosage information 1 hourly (Recorded from pump)

Patient Information

A patient information sheet is available (local adaptation of Royal College of Radiologists template). However peripheral arterial thrombolysis is sometimes an emergency procedure with minimal time for discussion about the care and issues involved. See Appendix.

7. Supporting Evidence

1 BEARD J. & GAINES P.2006 Vascular and Endovascular Surgery, Elsevier Saunders, Philadelphia