ACT

ACT TRIAL IS NOW COMPLETED AND CLOSED FOR ENROLMENT - JAN 26 2022

Are you Giving Thrombolysis? So You Have an ACT Patient, Register/Enroll!

1) To Randomize/Consent and perform other tasks - https://act.dctms.ca/

2) Take a picture of the vial of TNK or TPA and please email with the Subject Line "501-xxxx" (corresponding to the study patient number) to: Popel, Najla - najla.popel@sri.utoronto.ca , and Rick and Houman please.

ACT information Sheet

How to Mix TNK

This is from the makers of TNK: https://youtu.be/f9E746ceFw4

Reconstitution:

1. Remove flip-caps from the vial of tenecteplase and the vial of sterile water for injection.

2. Remove the shield assembly from the supplied B-D 10mL syringe with TwinPakTM Dual Cannula Device (leaving the red hub cannula affixed to the syringe) and place aside for later use. Do not discard the shield assembly.

3. Withdraw 10mL of sterile water for injection.

4. Inject the entire contents of the syringe (10mL) into the tenecteplase vial directing the diluent stream down the side of the vial. Slight foaming upon reconstitution is not unusual; any large bubbles will dissipate if the product is allowed to stand undisturbed for several minutes. (According to the teaching video from Calgary, we should avoid from injecting the water directly to the powder because it might denature it.)

5. Swirl gently to dissolve the tenecteplase powder. Do not shake.

6. The final concentration of tenecteplase is 5mg/mL

Administration:

1. Once dose is drawn into syringe, recap the red hub cannula with the shield assembly.

2. Flush IV tubing with 10mL normal saline prior to injecting TNKase.

3. Remove needle from TNKase syringe and connect syringe directly to IV port.

4. Administer medication by IV push over 5 seconds.

5.Follow immediately with another 10mL normal saline flush.

*You can find further information related to reconstitution and administration Tenecteplase via the IV Drug Monograph on Sunnynet http://sunnynet.ca/data/pharmacy/htdocs/iv_drugs/tenecteplase.pdf

but the dosage mentioned there is for Acute ST-Elevation MI NOT for this trial. The Dosage suggested on the Tenecteplase box is NOT for this trial. The dosage for AcT Trial should be 0.25mg/Kg, the dose should be between 3-5mL, not to exceed 5mL.


[Credit- Chan, Che-Lan stroke RN]

Key Considerations for ACT

There are some special considerations for the ACT trial:

IS THERE AN ORDER SETS SPECIFIC TO POST-TNK PATIENTS?

-No, at this time we would like everyone to use the post TPA order set, cross out the portion in the beginning of the order set that is specific to administration of TPA, and this then allows the remainder of the sheet and order set which follows a patient with regards to requirements for post thrombolysis care for the purpose of this trial (i.e. for those to receive TNK)


IS THERE SOMETHING SPECIAL ABOUTPOST-TNK MONITORING OF THESE PATIENTS WITH REGARDS TO HOW FREQUENTLY WE SHOULD BE DOING THINGS LIKE NIH STROKE SCALE?

-No -follow standard post stroke order sets, in this case we are completing the "Critical Care Acute Ischemic Stroke" Orderset, as we would do normally for patients being admitted to the ICU after thrombolysis or the combination of thrombolysis and thrombectomy.


WHAT IF THE NEURO INTERVENTIONALIST WOULD LIKE TO GIVE INTRA-ARTERIAL TNK?

-Similar to what happens with TPA, bring the vial with the patient, to the angio suite in case it is needed

-The intra-arterial tNK dose is 10-15% of the total dose given to the patient. So if the treatment dose is 3mL, the IA dose is 0.30-0.45ml. If it’s 5mL, the IA dose is 0.5-0.75mL. We can take this from the reconstituted tNK vial that would otherwise be waste