Effect of Pneumatic Tube System vs. Personnel Transport on Hemolysis Index in Emergency Department Blood Samples: A Randomized, Within-Patient Matched Trial (PTS-HEMO-ED)
5 de agosto de 2026 actualizado por: Emir Ünal, Marmara University Pendik Training and Research Hospital
Comparison of the Effect of Pneumatic Tube System and Personnel Transport on Hemolysis Index in Blood Samples From the Emergency Department: A Randomized, Within-Patient Matched, Single-Blind, Prospective Study
Hemolysis is the most common pre-analytical error in emergency department (ED) laboratory specimens and can lead to false elevation of intracellular analytes (potassium, LDH, AST, hemoglobin), resulting in misdiagnosis and unnecessary testing.
Blood samples in the ED are transported to the laboratory either by pneumatic tube systems (PTS) or manually by personnel.
Although PTS shortens turnaround time, the forces generated during transport may damage erythrocyte membranes and promote hemolysis.
Evidence on whether PTS increases hemolysis compared with personnel transport is inconsistent, partly because existing studies use parallel-group designs that cannot control for between-subject biological variability, and partly because findings differ across PTS brands and configurations.
The Sumetzberger Power Control PTS installed at Marmara University Pendik Training and Research Hospital (speed 4-5 m/s, 120 m, cushioned capsule) has not been prospectively validated for hemolysis risk.
This study uses a randomized, within-patient matched, single-blind design in which two simultaneously drawn yellow-cap tubes from the same patient are randomly allocated-one to PTS and one to personnel transport-thereby eliminating between-patient variability.
The primary outcome is the Hemolysis Index (HI) category (ordinal scale 0-5 corresponding to free hemoglobin thresholds of <50, 50-99, 100-199, 200-299, 300-500, and >500 mg/dL).
Secondary outcomes include the rate of clinically significant hemolysis (HI ≥ 1 / free Hb ≥ 50 mg/dL) and the correlation between transport time and HI.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
Detailed Description:
PNEUMATIC TUBE SYSTEM TECHNICAL SPECIFICATIONS:
The installed pneumatic tube system is a Sumetzberger Power Control system (Sumetzberger, Austria). The transit line length between the Emergency Department phlebotomy station and the central clinical laboratory is approximately 120 meters. System operating speed is set at 4-5 m/s. Transport capsules are cushioned with internal foam padding to minimize mechanical impact forces. Average transit duration ranges between 50 and 90 seconds.
BLINDING AND OPERATIONAL STANDARDIZATION (CONSORT 2025 Item 12b):
Blood collection is performed by trained emergency department phlebotomists using standard venipuncture technique. Two yellow-cap serum separator tubes (SST) are drawn sequentially during the same venipuncture procedure. Tubes are labeled with standardized participant study identifiers and tube sequence numbers (Tube #1 and Tube #2) without indicating transport allocation. Laboratory technicians operating the automated analyzer and assessing the Hemolysis Index remain fully blinded to transport allocation.
PATIENT AND PUBLIC INVOLVEMENT (PPI) STATEMENT (CONSORT 2025 Item 8):
Patients or members of the public were not involved in the design, conduct, reporting, or dissemination plans of this research. PPI was deemed non-applicable given the technical, pre-analytical nature of this laboratory quality evaluation study.
DATA SHARING STATEMENT (CONSORT 2025 Item 4):
De-identified individual participant data collected during the trial will be made available upon reasonable request to the corresponding investigator following publication.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
166
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Emir Ünal, Assistant Professor
- Número de teléfono: +905327766010
- Correo electrónico: emirunal@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Emir Unal, Assistant Professor
- Correo electrónico: emirunal@gmail.com
Ubicaciones de estudio
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Pendik
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Istanbul, Pendik, Turquía (Türkiye), 34899
- Marmara University Pendik Training and Research Hospital
-
Contacto:
- Emir ünal
- Número de teléfono: 05327766010
- Correo electrónico: emirunal@gmail.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Adults aged 18 years or older
- Presenting to the emergency department of Marmara University Pendik Training and Research Hospital
- Venous blood draw required for routine clinical care needing two or more yellow-cap (serum separator) tubes
- Written informed consent provided by the participant
Exclusion Criteria:
- Known underlying hemolytic disorder (e.g., hemolytic anemia, sickle cell disease, G6PD deficiency, autoimmune hemolytic anemia, or TTP/HUS)
- Macroscopic hemolysis visible in the sample tube immediately after phlebotomy
- Age younger than 18 years
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: PTS-First Sequence
Participants from whom two yellow-cap serum separator blood tubes are drawn simultaneously.
Tube #1 (first drawn) is transported via the pneumatic tube system (PTS), and Tube #2 (second drawn) is transported by manual personnel.
Both tubes are dispatched simultaneously.
|
Blood sample transport using the Sumetzberger Power Control pneumatic tube system (Sumetzberger, Austria).
The system operates at a speed of 4-5 m/s over a distance of approximately 120 meters using cushioned capsules.
Transport duration ranges between 50 and 90 seconds.
Blood sample transport performed manually by emergency department staff carrying the tube on foot from the phlebotomy area to the central clinical laboratory.
Transport is dispatched simultaneously with the paired pneumatic tube sample.
|
|
Comparador activo: Personnel-First Sequence
Participants from whom two yellow-cap serum separator blood tubes are drawn simultaneously.
Tube #1 (first drawn) is transported by manual personnel, and Tube #2 (second drawn) is transported via the pneumatic tube system (PTS).
Both tubes are dispatched simultaneously.
|
Blood sample transport using the Sumetzberger Power Control pneumatic tube system (Sumetzberger, Austria).
The system operates at a speed of 4-5 m/s over a distance of approximately 120 meters using cushioned capsules.
Transport duration ranges between 50 and 90 seconds.
Blood sample transport performed manually by emergency department staff carrying the tube on foot from the phlebotomy area to the central clinical laboratory.
Transport is dispatched simultaneously with the paired pneumatic tube sample.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hemolysis Index (HI) Category in PTS-Transported vs. Personnel-Transported Tubes
Periodo de tiempo: At laboratory analysis (within 30 minutes of blood draw)
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Ordinal 6-category HI scale (0=<50, 1=50-99, 2=100-199, 3=200-299, 4=300-500, 5=>500 mg/dL free hemoglobin) as reported by the automated analyser.
Higher category indicates more hemolysis.
Compared between PTS and personnel tube from the same patient (paired).
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At laboratory analysis (within 30 minutes of blood draw)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rate of Clinically Significant Hemolysis (HI ≥ 1) in PTS-Transported vs. Personnel-Transported Tubes
Periodo de tiempo: At laboratory analysis (within 30 minutes of blood draw)
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Proportion of tubes with HI category ≥ 1 (free haemoglobin ≥ 50 mg/dL), the threshold at which samples are typically flagged for rejection by the laboratory.
Dichotomous outcome (0 vs ≥1) compared between matched tube pairs.
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At laboratory analysis (within 30 minutes of blood draw)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Spearman Correlation Between Tube Transport Time and HI Category
Periodo de tiempo: At laboratory analysis (within 30 minutes of blood draw)
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Spearman rank correlation coefficient (ρ) between recorded PTS transport time (seconds, 50-90 s range) and the HI category of the PTS tube.
Exploratory analysis.
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At laboratory analysis (within 30 minutes of blood draw)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Emir Ünal, Marmara University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de noviembre de 2026
Finalización del estudio (Estimado)
1 de enero de 2027
Fechas de registro del estudio
Enviado por primera vez
5 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de agosto de 2026
Publicado por primera vez (Actual)
10 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MU-KAEK-2026-09.2029.26-0645
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual participant data collected during the trial that underlie the published results will be made available upon reasonable request to qualified scientific researchers.
Marco de tiempo para compartir IPD
Data will become available beginning 3 months following publication and ending 36 months following article publication.
Criterios de acceso compartido de IPD
Proposals should be submitted to the corresponding investigator via email (emirunal@gmail.com).
Requestors must provide a methodologically sound research proposal and sign a data use agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .