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NCT Number: NCT07755007

Effect of Pneumatic Tube System vs. Personnel Transport on Hemolysis Index in Emergency Department Blood Samples: A Randomized, Within-Patient Matched Trial

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.

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Key information

Conditions

Hemolysis Blood Specimen Collection Diagnostic Errors Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location contact

Emir ünal

CONTACT

[email protected]

05327766010

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pneumatic Tube System Transport

Procedure

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.

Manual Personnel Transport

Procedure

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.

Primary outcomes

  1. Hemolysis Index (HI) Category in PTS-Transported vs. Personnel-Transported Tubes

    Time frame: 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).

Secondary outcomes

  1. Rate of Clinically Significant Hemolysis (HI ≥ 1) in PTS-Transported vs. Personnel-Transported Tubes

    Time frame: 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.

Other outcomes

  1. Spearman Correlation Between Tube Transport Time and HI Category

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emir Unal, Assistant Professor

CONTACT

[email protected]

Emir Ünal, Assistant Professor

CONTACT

[email protected]

+905327766010

Sponsors and collaborators

Lead sponsor

Marmara University Pendik Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: PTS-HEMO-ED

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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