Stroke Thrombolytic Therapy with Tenecteplase and Thrombectomy Pathway

Introduction

Stroke is the most common cause of permanent disability, with approximately 85% of strokes being ischaemic and the remaining 15% being haemorrhagic. The burden of stroke is heavy for both the patient and for society.

Thrombolytic therapy with tenecteplase within 4.5 hours of symptom onset significantly reduces death and disability at 90 days. Tenecteplase is a recombinant fibrin-specific plasminogen activator that binds to the fibrin component of the thrombus and selectively converts thrombus-bound plasminogen to plasmin, which degrades the fibrin matrix of the thrombus.

Stroke thrombolysis is delivered jointly by stroke consultants in NHS Ayrshire & Arran and NHS Lanarkshire. In hours via face-to-face delivery and out of hours consultation with the patient via video conferencing. Stroke consultants will review the CT brain scan and make the decision whether to offer thrombolysis or not.

All potential stroke thrombolysis patients should be admitted to the Emergency Department (ED) at University Hospital Crosshouse (UHC). See stroke thrombolysis / thrombectomy pathway below:

Inclusion criteria

  • Clinical diagnosis of ischaemic stroke causing a measurable deficit
  • Onset of symptoms within 4.5 hours
  • CT appearances consistent with acute ischaemic stroke/normal CT
  • Risks and benefits explained to patient/relative and verbal consent given

Exclusion criteria

Absolute contraindications

  • Symptoms of stroke began >4.5 hours prior to start of tenecteplase injection
  • Time of onset unknown
  • Hypersensitivity to tenecteplase or to any of the excipients or to gentamicin (a trace residue from the manufacturing process). For patients with hypersensitivity to gentamicin, alteplase infusion would be indicated and is available in UHC and University Hospital Ayr (UHA) Emergency Departments (ED), UHC intensive care unit (ICU), UHC emergency room and UHC ward 4F.

Tenecteplase is contraindicated in cases where there is a high risk of haemorrhage such as the following examples below. However, patients will be assessed on an individual case basis.

    • Significant bleeding disorder at present or within the past 6 months
    • Known haemorrhagic diathesis
    • Patients receiving effective oral anticoagulant treatment, e.g., DOAC or warfarin sodium (INR ≥1.7)
    • Known history of or suspected intracranial haemorrhage (ICH). Evidence of ICH on CT scan
    • Symptoms suggestive of subarachnoid haemorrhage even if CT scan is normal
    • Persistent uncontrolled arterial hypertension - systolic BP >185mmHg or diastolic BP >110mmHg despite active management (i.e. IV labetalol or glyceryl trinitrate)
    • Acute pericarditis and/or subacute bacterial endocarditis
    • Arterial aneurysm and known arterial/venous malformation
    • Active peptic ulceration
    • Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
    • Platelet count below 100x109/L
    • Prior stroke within the last 3 months
    • Treatment with tenecteplase within the last 14 days for ischaemic stroke
    • Recent trauma to the head or cranium

Relative contraindications

Treatment can go ahead if the benefits of tenecteplase appear to outweigh risks, provided patient and/or carers accept associated risk

  • Minor neurological deficit (NIHSS ≤4) or symptoms rapidly improving before start of tenecteplase injection
  • Severe stroke as assessed clinically (e.g. NIHSS>25) and/or by appropriate imaging techniques
  • Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
  • Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
  • Neoplasm with increased bleeding risk
  • Recent (within 7 days) puncture of a non-compressible blood vessel (e.g., subclavian or jugular vein puncture)
  • Prolonged cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks
  • Acute pancreatitis
  • Seizure at onset of stroke
  • Patients with any history of prior stroke and concomitant diabetes
  • Blood glucose (<2.8mmol/L or >22.2mmol/L)
  • Major surgery (including obstetric delivery), biopsy of a parenchymal organ, or significant trauma within the past 2 months 
  • Lumbar puncture in last 7 days
  • Pregnancy

Drug management with tenecteplase

Treatment must be started within 4.5 hours of onset of stroke symptoms - decision to treat made by stroke consultant

Dosing and administration

The appropriate presentation of tenecteplase product should be chosen carefully and in line with the indication. The 25 mg presentation of tenecteplase is only intended for use in acute ischaemic stroke.

Tenecteplase should be administered on the basis of body weight, with a maximum single dose of 5000 units (25mg). The dose and volume of reconstituted tenecteplase can be calculated as follows:

Patients' body weight category (kg) Volume of reconstituted solution (ml) Tenecteplase (units) Tenecteplase (mg)

<60kg

3.0ml

3 000 units

15.0mg

≥60kg to <70kg

3.5ml

3 500 units

17.5mg

≥70kg to <80kg

4.0ml

4 000 units

20.0mg

≥80kg to <90kg

4.5ml

4 500 units

22.5mg

≥90kg

5.0ml

5 000 units

25.0mg

N.B. The required dose should be administered as a single intravenous bolus over approximately 5 to 10 seconds.

Preparation

  1. Remove the crimp cap from the vial of tenecteplase 5000 units (25mg).
  2. Fill a syringe with 5 mL of sterile water for injection and penetrate the vial stopper in the middle with the needle.
  3. Add all the sterile water for injections into the vial by pushing the syringe plunger down slowly to avoid foaming.
  4. Keep the syringe attached to the vial and reconstitute by swirling gently.
  5. The reconstituted solution for injection results in a colourless to pale yellow, clear solution. Only clear solution without particles should be used.
  6. Directly before the solution is administered, invert the vial with the syringe still attached, so that the syringe is below the vial.
  7. Transfer the appropriate volume of tenecteplase reconstituted solution into the syringe, based on the patient's weight.
  8. Administer intravenously in about 5 to 10 seconds.
  9. The line should be flushed with a small volume of up to 10mL of sodium chloride 0.9% after tenecteplase injection for a proper delivery.
  10. Any unused reconstituted solution should be discarded.

Compatibilities

A pre-existing intravenous line of sodium chloride 0.9% may be used for the administration of reconstituted tenecteplase. No other medicinal product should be added to the injection solution. Tenecteplase should not be administered in a line containing glucose as tenecteplase is incompatible with glucose solution.

Prescribing of tenecteplase

Tenecteplase should be prescribed on Hospital Electronic Prescribing and Medicines Administration system (HEPMA) or on ED prescribing section.

Adverse effects

There are significant risks with administration of thrombolysis which can be fatal. Close monitoring and prompt response to deterioration are important in the safe administration of treatment. Risks include ICH, active bleeding, acute hypertension and anaphylaxis. Be alert to the early signs of complications and initiate treatment at the earliest opportunity. Close monitoring should be carried out prior to tenecteplase injection and after for 24 hours following administration as detailed in thrombolysis care plan documentation.

Any serious adverse effects should be reported via the Yellow Card Scheme. Any clinical incidents should be reported via DATIX system and should be highlighted through the clinical governance process.

Complications

Complications can occur during and post tenecteplase delivery - see management guidelines below:

 

Guideline reviewed February 2025
Page updated March 2025



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