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. august 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
166
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Emir Ünal, Assistant Professor
- Telefonnummer: +905327766010
- E-mail: emirunal@gmail.com
Undersøgelse Kontakt Backup
- Navn: Emir Unal, Assistant Professor
- E-mail: emirunal@gmail.com
Studiesteder
-
-
Pendik
-
Istanbul, Pendik, Tyrkiet (Türkiye), 34899
- Marmara University Pendik Training and Research Hospital
-
Kontakt:
- Emir ünal
- Telefonnummer: 05327766010
- E-mail: emirunal@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hemolysis Index (HI) Category in PTS-Transported vs. Personnel-Transported Tubes
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of Clinically Significant Hemolysis (HI ≥ 1) in PTS-Transported vs. Personnel-Transported Tubes
Tidsramme: 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)
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Spearman Correlation Between Tube Transport Time and HI Category
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Emir Ünal, Marmara University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. november 2026
Studieafslutning (Anslået)
1. januar 2027
Datoer for studieregistrering
Først indsendt
5. august 2026
Først indsendt, der opfyldte QC-kriterier
5. august 2026
Først opslået (Faktiske)
10. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MU-KAEK-2026-09.2029.26-0645
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
Data will become available beginning 3 months following publication and ending 36 months following article publication.
IPD-delingsadgangskriterier
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-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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