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STRATUS will evaluate the use of small-volume ("soft-draw") blood collection tubes for laboratory testing in reducing anemia and transfusion in intensive care unit patients without significant adverse consequences. This is a simple, cost-neutral intervention that could improve the quality of patient care and reduce the harms of frequent laboratory testing.
The STRATUS Pilot Study is a prospective observational study (before-after design) to assess the feasibility of implementing a full-scale randomized trial powered for clinical outcomes (RBC transfusion, incidence and severity of anemia). Identification of barriers and facilitators of implementation will enhance the conduct of the full-scale trial and facilitate incorporation of the intervention into routine practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Before) Period | Use of standard-volume blood collection tubes (6 weeks) |
| |
| Intervention (After) Period | Use of small-volume ("soft-draw") blood collection tubes (6 weeks following 2-week washout period) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Small-Volume | Device | Small-volume (2 - 3 mL "soft-draw" Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful crossover from standard-volume to small-volume tubes | Defined as at least 95% correct tubes collected during an audit of tubes in the storage area at the end of the washout period | 2 week washout period |
| Adherence to the correct tube size during the intervention period | Defined as at least 95% adherence to allocated tube size evaluated during audits of tubes in the storage area | 6 week intervention period |
| Sufficient volume for testing with small-volume tubes | Defined as <3% of samples reported as inadequate volume for testing | 6 week intervention period |
| Acceptability of the intervention by end-users | Acceptability qualitatively evaluated during structured focus group discussions | 6 week intervention period |
| Complete primary data collection | Defined as at least 95% of patients with complete data collected | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in blood loss | Reduction in blood loss from routine hematology, chemistry, and coagulation testing using small-volume tubes. | 12 weeks |
| RBC units transfused | Number of RBC units transfused per patient-day in the ICU. |
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Investigative Site Eligibility:
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All adult patients admitted to the participating intensive care unit at the investigative site.
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Siegal, MD | Population Health Research Institute, McMaster University, Hamilton Health Sciences | Principal Investigator |
| Stuart Connolly, MD | Population Health Research Institute, McMaster University, Hamilton Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences - Hamilton General Hospital | Hamilton | Ontario | L8L2X2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37505420 | Derived | Siegal DM, Belley-Cote EP, Lee SF, Robertson T, Hill S, Benoit P, Meeks B, Owen J, Roglich T, Zotova E, Connolly SJ. Small-volume tubes to reduce anemia and transfusion (STRATUS): a pilot study. Can J Anaesth. 2023 Nov;70(11):1797-1806. doi: 10.1007/s12630-023-02548-6. Epub 2023 Jul 28. |
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| Standard-Volume | Device | Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes. |
|
| 12 weeks |
| Change in hemoglobin | Change in hemoglobin level from ICU admission to ICU discharge (or death) adjusted for RBC transfusion. | 12 weeks |
| ICU and hospital length of stay | ICU and hospital length of stay | 12 weeks |
| ICU and hospital mortality | ICU and in-hospital mortality | 12 weeks |