Small-Volume Tubes to Reduce Anemia and Transfusion
Palabras clave
Abstracto
Descripción
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.
fechas
Verificado por última vez: | 04/30/2020 |
Primero enviado: | 06/20/2018 |
Inscripción estimada enviada: | 07/02/2018 |
Publicado por primera vez: | 07/05/2018 |
Última actualización enviada: | 05/10/2020 |
Última actualización publicada: | 05/12/2020 |
Fecha de inicio real del estudio: | 12/31/2018 |
Fecha estimada de finalización primaria: | 12/31/2020 |
Fecha estimada de finalización del estudio: | 05/31/2021 |
Condición o enfermedad
Intervención / tratamiento
Device: Intervention Period
Device: Control Period
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Active Comparator: Control Period Standard-Volume Blood Collection Tubes | Device: Control Period Standard-volume (≥ 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes. |
Experimental: Intervention Period Small-Volume Blood Collection Tubes ("soft-draw") | Device: Intervention Period Small-volume vacuum (< 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes. |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | ICUs will be eligible if they meet the following criteria: 1. Adult ICU 2. At least 14 level 2-3 ICU beds with capacity for invasive mechanical ventilation 3. Use of vacuum tubes for routine blood collection 4. Able to achieve at least 25% estimated reduction in blood volume by switching to small-volume vacuum tubes 5. Electronic administrative and health record data available for data collection |
Salir
Medidas de resultado primarias
1. RBC Transfusions [through study completion, an average of 1.5 years]
Medidas de resultado secundarias
1. Hemoglobin Concentration [through study completion, an average of 1.5 years]
2. ICU and hospital length of stay [through study completion, an average of 1.5 years]
3. ICU and hospital mortality [through study completion, an average of 1.5 years]