Small-Volume Tubes to Reduce Anemia and Transfusion

1. Small-Volume Tubes to  Reduce Anemia and Transfusion Site Study Team Training Slides

2. Study Rationale

3. Study Rationale Anemia is a common problem in hospitals

4. Study Rationale Anemia is a common problem in hospital • Increased 30-day mortality • Longer ICU length of stay • Longer hospital length of stay Anemia is associated with poor outcomes

5. Study Rationale Anemia is a common problem in hospital • 40% of all ICU patients receive ≥1 RBC transfusions • 75% of patients in ICU for >1 week receive ≥1 RBC transfusion • 50% of transfusions given in absence of any hemorrhage Anemia is associated with poor outcomes Anemia leads to high transfusion rates

6. Study Rationale Anemia is a common problem in hospital Anemia is associated with poor outcomes Anemia leads to high transfusion rates RBC transfusions cause harm

7. Anemia can be caused by different factors

8. Laboratory Testing Causes Blood Loss • 21 mL/day taken in patients with acute MI • 41 mL/day taken in ICU patients • Like losing 1 unit of blood every ~8 days

9. Small-volume blood collection tubes • Also known as ‘soft-draw’ tubes • Draw 25-50% less blood due to less vacuum • Same cost • Same concentration of anticoagulant • Same physical dimensions • Often routinely used in adults

10. Study Protocol Overview

11. Intervention Standard-draw tubes Small-volume tubes Source: BD Lifesciences – Preanalytical Systems, Product Catalogue 2018, Canada

12. Laboratory

13. Tube Characteristics • Same physical dimensions as current tubes • Both internal and external* • Fits most collection devices • Reduced vacuum in tube means less sample drawn into tubes • Correct anticoagulant concentration with reduced volumes

14. Fits Most Instruments • Biochemistry • Abbott • Beckman • Ortho • Siemens • Roche • Haematology • Beckman Coulter • Sysmex • Coagulation

15. Tube Validation Study • Purpose: Demonstrate Equivalence Between “Soft Draw & Regular Tubes” • Population: 20 Healthy Adult Males and Females • Sites: • Hamilton: Abbott • Brampton: Siemens and Beckman • London: Roche • Intervention: “Soft-draw” (2-3 ml) Vacutainer tubes, Becton DickinsonEDTA, Lithium-Heparin • Control: Standard (4-6 ml) Vacutainer tubes, Becton Dickinson EDTA, Lithium-heparin • Outcome: Results Comparison

16. Tube Validation Study - Results

17. Tube Validations study – Conclusions • All tests showed acceptable correlation within the limit of error • None of the tests required further blood collection, therefore “soft-draw” volumes were adequate for testing purposes • The new small volume method meets the acceptable standards of performance

18. Blood Collection

19. Blood Collection Processes If you are not familiar with the institutional guidelines or have any questions, contact your Nurse Educator or the STRATUS Study Research Coordinator at your site.

20. Small-volume Tubes • Same blood collection procedure as standard-volume tubes • Draw less blood due to less vacuum in the tube • Same ratio of anticoagulant to sample • Tube will automatically fill to the maximum fill volume • The maximum fill-line may be lower than on standard-volume tube • This is demonstrated over the next few slides… Standard-volume tubes in these slides may differ from tubes available at your site. Always refer to the fill-line on the tube label!

21. How to identify the fill-line? The fill line is indicated on the label

22. Why fill to the fill-line? Correct test results  Less blood drawn from patients

23. Citrate (Blue) Tube 1.8 mL tube Small-volume Tube 2.7 mL tube Standard-volume Tube Will be switched to Fill line Fill line Fill Line Etched on Tube

24. Serum (Red) Tube 4mL tube Standard-volume Tube 2mL tube Small-volume Tube Will be switched to Fill line Fill line

25. Lithium-heparin (Green) Tube 6 mL tube Standard-volume Tube 2 mL tube Small-volume Tube Will be switched to Fill line Fill line

26. Barricor (Green) Tube 3mL tube Small-volume Tube 4.5 mL tube Standard-volume Tube Will be switched to Fill line Fill line

27. PST Gel + Lithium-heparin (Lime-Green) Tube 3.5 mL tube Standard-volume Tube 3mL tube Small-volume Tube Will be switched to Fill line Fill line

28. Serum Separation (Gold) Tube 2mL tube Small-volume Tube 4mL tube Standard-volume Tube Fill line Will be switched to Fill line

29. EDTA (Lavender) Tube 4mL tube Standard-volume Tube 2mL tube Small-volume Tube Will be switched to Fill line Fill line

30. Sodium Fluoride/Na2(Grey) Tube 4mL tube Standard-volume Tube 2mL tube Small-volume Tube Will be switched to Fill line Fill line

31. Site Activities

32. Site Activities • Sites will be responsible for the following: • Implementing the small-volume tubes according to the randomization schedule • Downloading and transferring data (obtained from already existing electronic sources) • STRATUS Coordinating Centre will provide: • Education and Training • Assistance with supply of the small-volume blood collection tubes

33. Stepped Wedge Cluster Randomized • Each step = 6 weeks • 2 sites assigned to switch at each step • Only switch once!

34. Study Implementation and Training

35. Educational Materials • Tools: • Video / slides • Posters

36. Data Collection • Electronic data transfer of administrative data • Cumulative data transfers every 2 months • No data manipulation • Excel or csv files • Secure mode of transfer (SFTP - Secured File Transfer folder) • Refer to Data Specifications Document for more details • Contact stratus@phri.ca if you require access to the SFTP

37. Data Collection variables (required) * Data must be available in order for your site to participate in STRATUS.

38. Data Collection variables (additional)

39. Thank you for completing this course! This study is a multi-disciplinary collaborative effort. We appreciate your assistance. Contact your site coordinator or stratus@phri.ca if you have questions on STRATUS!