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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 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

166

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Emir Ünal, Assistant Professor
  • Telefoonnummer: +905327766010
  • E-mail: emirunal@gmail.com

Studie Contact Back-up

Studie Locaties

  • Turkije (Türkiye)
    • Pendik
      • Istanbul, Pendik, Turkije (Türkiye), 34899
        • Marmara University Pendik Training and Research Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: Pneumatic Tube System Transport
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.
Procedure: Manual Personnel Transport
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.
Actieve vergelijker: 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.
Procedure: Pneumatic Tube System Transport
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.
Procedure: Manual Personnel Transport
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hemolysis Index (HI) Category in PTS-Transported vs. Personnel-Transported Tubes
Tijdsspanne: At laboratory analysis (within 30 minutes of blood draw)
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).
At laboratory analysis (within 30 minutes of blood draw)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of Clinically Significant Hemolysis (HI ≥ 1) in PTS-Transported vs. Personnel-Transported Tubes
Tijdsspanne: At laboratory analysis (within 30 minutes of blood draw)
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.
At laboratory analysis (within 30 minutes of blood draw)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Spearman Correlation Between Tube Transport Time and HI Category
Tijdsspanne: At laboratory analysis (within 30 minutes of blood draw)
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.
At laboratory analysis (within 30 minutes of blood draw)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Marmara University Pendik Training and Research Hospital

Onderzoekers

  • Hoofdonderzoeker: Emir Ünal, Marmara University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 november 2026

Studie voltooiing (Geschat)

1 januari 2027

Studieregistratiedata

Eerst ingediend

5 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 augustus 2026

Eerst geplaatst (Werkelijk)

10 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

5 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MU-KAEK-2026-09.2029.26-0645

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

Data will become available beginning 3 months following publication and ending 36 months following article publication.

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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