Small-Volume Tubes to Reduce Anemia and Transfusion

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EstadoReclutamiento

Patrocinadores

Population Health Research Institute

ENSAYO CLÍNICO: NCT03578419

BioSeek: nct03578419

Palabras clave

Abstracto

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.

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

Blood Loss Anemia

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]

Average number of red blood cell (RBC) units transfused per patient during ICU admission among patients admitted to ICU for 48 hours or longer.

Medidas de resultado secundarias

1. Hemoglobin Concentration [through study completion, an average of 1.5 years]

Change in hemoglobin concentration from ICU admission to ICU discharge adjusted for number of RBC transfusions received

2. ICU and hospital length of stay [through study completion, an average of 1.5 years]

Length of stay in the ICU and hospital

3. ICU and hospital mortality [through study completion, an average of 1.5 years]

Mortality rates in the ICU and hospital