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 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
166
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Emir Ünal, Assistant Professor
- Telefonnummer: +905327766010
- E-Mail: emirunal@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Emir Unal, Assistant Professor
- E-Mail: emirunal@gmail.com
Studienorte
-
-
Pendik
-
Istanbul, Pendik, Türkei (türkiye), 34899
- Marmara University Pendik Training and Research Hospital
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Kontakt:
- Emir ünal
- Telefonnummer: 05327766010
- E-Mail: emirunal@gmail.com
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
|
Aktiver 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Hemolysis Index (HI) Category in PTS-Transported vs. Personnel-Transported Tubes
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Rate of Clinically Significant Hemolysis (HI ≥ 1) in PTS-Transported vs. Personnel-Transported Tubes
Zeitfenster: 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.
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At laboratory analysis (within 30 minutes of blood draw)
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Spearman Correlation Between Tube Transport Time and HI Category
Zeitfenster: 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.
|
At laboratory analysis (within 30 minutes of blood draw)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Emir Ünal, Marmara University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. August 2026
Primärer Abschluss (Geschätzt)
1. November 2026
Studienabschluss (Geschätzt)
1. Januar 2027
Studienanmeldedaten
Zuerst eingereicht
5. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
5. August 2026
Zuerst gepostet (Tatsächlich)
10. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- MU-KAEK-2026-09.2029.26-0645
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
Data will become available beginning 3 months following publication and ending 36 months following article publication.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .