I-SPOT

I-SPOT - The Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial 

I-SPOT was designed as a complimentary clinical trial to SHINE, and includes 315 SHINE patients. Please see the full Project Summary and click on the links below for more information. 

Protocol

Education and Training

FAQs

Toolbox

 

 

Protocol V.2 

V. 2 with tracked changes

V. 2 summary of changes

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Education and Training

*Please view the training slides AND watch the training video below. When you are finished please click on the Certificate link, enter the required information, save and then email it to your Study Coordinator.

Slides (V. 2)

Video:

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FAQs

Q. Are patients excluded from I-SPOT if they receive fibrinolytic/thrombolytic treatment?
A. In version 2 of the I-SPOT protocol subjects who receive intravenous tPA are eligible for enrollment. However, all subjects who receive intra-arterial fibrinolytic/thrombolytic therapy continue to be excluded from I-SPOT.  

Q. My patient was on an anticoagulant but has not taken it for 7 days.  They meet all other eligibility criteria. Can I enroll in I-SPOT?
A. If the patient has been off the anticoagulant for 7 or more days and you expect that the patient will not be started back on the anticoagulant before the 48 hour draw you may enter them into I-SPOT.

Q. When should the 48 hour blood sample be drawn?
A. The blood must be drawn between 46-54 hours from the time of randomization. Blood should be collected at the time of the scheduled finger stick check closest to 48 hours post randomization. If the time of the scheduled finger check coincides with a meal, the meal should be held until after the scheduled finger stick check and blood draw.

Q. Can blood be drawn from an existing peripheral or central venous line?
A. We strongly recommend that blood be drawn from a fresh venous stick.  Blood drawn through the existing peripheral or central lines may become diluted or contaminated with heparin flushes; both of these will compromise the measurements.
In the event that a fresh venous stick is not feasible blood may be drawn from existing venous lines as long as at least 5-10 cc (5cc minimum for peripheral and 10cc minimum for central lines) of the initial blood is discarded before specimen collection and a Vacutainer system is used to draw specimens (no transferring of blood from a syringe into tubes). Blood should not be drawn from heparinized lines. 

Q. Can blood be drawn from an arterial line?
A. No, arterial blood may affect some of the measurements. Please use venous blood only.

Q. From what time point is the 48 hours measured from?
A. The time is measured from time of randomization.  The 48 hour blood draw should be done 48 hours (-2/+6) after randomization (between 46 and 54 hours).

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Toolbox

Lab Manual V.5 

V.5 with tracked changes

Exclusion Medication List V.2

Clarification Letter for IRBs
This letter is for IRBs that have a concern about sample handling/banking. The letter states that I-SPOT will not bank samples.

I-SPOT Readiness Checklist 

Consent Addendum
English       Spanish    Certificate of Translation

CRFs V.5

Nomogram Instructions: How to convert RPM to RCF (or G-force)

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