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

NCT07755007 | Not Yet Recruiting

• 1 other identifier: MU-KAEK-2026-09.2029.26-0645
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemolysis; Diagnostic Errors; Blood Specimen Collection

Keywords

Pneumatic Tube System; Blood Specimen Transport; Hemolysis Index; Emergency Service, Hospital; Pre-Analytical Variability; Sumetzberger

Outcome Measures

Primary Outcomes (1)

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

  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)

Secondary Outcomes (1)

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

  At laboratory analysis (within 30 minutes of blood draw)

Other Outcomes (1)

• Spearman Correlation Between Tube Transport Time and HI Category

  At laboratory analysis (within 30 minutes of blood draw)

Study Arms (2)

PTS-First Sequence

EXPERIMENTAL

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; Procedure: Manual Personnel Transport

Personnel-First Sequence

ACTIVE COMPARATOR

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; Procedure: Manual Personnel Transport

Interventions

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.

PTS-First Sequence; Personnel-First Sequence

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.

PTS-First Sequence; Personnel-First Sequence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

Related Publications (1)

• Moghaddasi M, Nabovvati M, Koushki A, Soltansanjari M, Sardarinia M, Mohebi N, Rabani S. Randomized control trial of evaluation of Clemastine effects on visual evoked potential, nerve fiber layer and ganglion cell layer complex in patients with optic neuritis. Clin Neurol Neurosurg. 2020 Jun;193:105741. doi: 10.1016/j.clineuro.2020.105741. Epub 2020 Feb 17.

  PMID: 32145678 RESULT

MeSH Terms

Conditions

Hemolysis; Emergencies

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Emir Ünal

  Marmara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emir Ünal, Assistant Professor

CONTACT

+905327766010; emirunal@gmail.com

Emir Unal, Assistant Professor

CONTACT

emirunal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory technicians operating the automated analyzer and interpreting the Hemolysis Index are fully blinded to the transport allocation of each tube. Tubes are identified only by study participant ID and sequence order.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A randomized, within-patient matched crossover design in which two serum separator blood tubes drawn simultaneously from the same participant are randomly allocated to two different transport sequences: pneumatic tube system transport or manual personnel transport.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available beginning 3 months following publication and ending 36 months following article publication.
• Access Criteria: 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.

Locations

TU (1)