Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Blood sampling can cause significant unnecessary blood loss particularly in the intensive care unit (ICU). Blood loss contributes to anemia which is highly prevalent in the ICU and is associated with major adverse cardiovascular outcomes and death. Red blood cell (RBC) transfusions to correct anemia also have significant health risks.
Using a stepped wedge cluster randomized trial design, the specific aim of the STRATUS study is to evaluate whether the routine use of small-volume blood collection tubes reduces RBC transfusion compared to standard-volume blood collection tubes in adult ICU patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Period | Active Comparator | Standard-Volume Blood Collection Tubes |
|
| Intervention Period | Experimental | Small-Volume Blood Collection Tubes ("soft-draw") |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Small-Volume Blood Collection Tubes | Device | Small-volume vacuum (< 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes. |
| Measure | Description | Time Frame |
|---|---|---|
| RBC Transfusions | Average number of red blood cell (RBC) units transfused per patient during ICU admission among patients admitted to ICU for 48 hours or longer. | through study completion, an average of 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Concentration | Change in hemoglobin concentration from ICU admission to ICU discharge adjusted for number of RBC transfusions received | through study completion, an average of 1.5 years |
| ICU and hospital length of stay |
Not provided
ICUs will be eligible if they meet the following criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deborah Siegal, MD MSc FRCPC | Population Health Research Institute; McMaster University | Principal Investigator |
| Stuart Connolly, MD | Population Health Research Institute; McMaster University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba - Health Sciences Centre | Winnipeg | Manitoba | Canada | |||
| Saint John Regional Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37824152 | Derived | Siegal DM, Belley-Cote EP, Lee SF, Hill S, D'Aragon F, Zarychanski R, Rochwerg B, Chasse M, Binnie A, Honarmand K, Lauzier F, Ball I, Al-Hazzani W, Archambault P, Duan E, Khwaja K, Lellouche F, Lysecki P, Marquis F, Naud JF, Shahin J, Shea J, Tsang JLY, Wang HT, Crowther M, Arnold DM, Di Sante E, Marfo G, Kovalova T, Fonguh S, Vincent J, Connolly SJ. Small-Volume Blood Collection Tubes to Reduce Transfusions in Intensive Care: The STRATUS Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1872-1881. doi: 10.1001/jama.2023.20820. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 2, 2025 | |
| Reset | Sep 24, 2025 |
Not provided
A stepped wedge cluster randomized trial in which ICUs (clusters) switch from a strategy of blood collection using standard-draw tubes (control) to soft-draw tubes (intervention). In this design, the timing at which individual ICUs switch to the intervention is randomly assigned.
Not provided
Not provided
Not provided
Not provided
| Standard-Volume Blood Collection Tubes | Device | Standard-volume (≥ 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes. |
|
Length of stay in the ICU and hospital
| through study completion, an average of 1.5 years |
| ICU and hospital mortality | Mortality rates in the ICU and hospital | through study completion, an average of 1.5 years |
| Saint John |
| New Brunswick |
| Canada |
| William Osler Health System - Brampton Civic | Brampton | Ontario | Canada |
| Joseph Brant Hospital | Burlington | Ontario | Canada |
| William Osler Health System - Etobicoke General | Etobicoke | Ontario | Canada |
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| Juravinski Cancer Centre | Hamilton | Ontario | Canada |
| St. Joseph's Hospital | Hamilton | Ontario | Canada |
| London Health Sciences Centre - CCTC | London | Ontario | Canada |
| London Health Sciences Centre - University Hospital | London | Ontario | Canada |
| St. Catharine's General Hospital | Saint Catherines | Ontario | Canada |
| Hôtel-Dieu de Lévis | Lévis | Quebec | Canada |
| CHUM - AB cardiothoracic | Montreal | Quebec | Canada |
| CHUM - CD transplants/surgical ICU | Montreal | Quebec | Canada |
| CHUM - EF neuro ICU | Montreal | Quebec | Canada |
| Maisonneuve-Rosemont | Montreal | Quebec | Canada |
| Montreal General Hospital | Montreal | Quebec | Canada |
| Royal Victoria Hospital | Montreal | Quebec | Canada |
| CHU de Quebec - Enfant-Jésus | Québec | Quebec | Canada |
| Universite de Sherbrooke - Hopital Fleurimont | Sherbrooke | Quebec | Canada |
| Universite de Sherbrooke - Hôtel-Dieu | Sherbrooke | Quebec | Canada |
| Ciuss-McQ-Chaur | Trois-Rivières | Quebec | Canada |
| CHU de Quebec - Hotel Dieu | Québec | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Québec | Québec | Canada |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 2, 2025 | Sep 24, 2025 |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided