An interventional study of Pneumatic Tube System Transport and Manual Personnel Transport in Hemolysis, Diagnostic Errors and Blood Specimen Collection, sponsored by Marmara University Pendik Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Marmara University Pendik Training and Research Hospital · Not applicable, Interventional, and Other
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, split-sample (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.
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.
BLOOD COLLECTION PROTOCOL
Blood collection is performed by trained emergency department phlebotomists using standard venipuncture technique. Tubes are drawn from a single venipuncture in the standard order of draw: (1) blue-cap coagulation tube, not used in the study; (2) yellow-cap serum separator tube #1; (3) yellow-cap serum separator tube #2; (4-5) any additional clinically indicated tubes, not used in the study. The two yellow-cap serum separator tubes are dispatched simultaneously by the two transport routes and are analysed simultaneously on arrival at the laboratory, so that waiting time does not act as a pre-analytical variable.
RANDOMIZATION AND ALLOCATION CONCEALMENT (CONSORT 2025 Items 15-17)
Allocation is by computer-generated block randomization with a block size of four. The allocation sequence assigns each participant to Sequence A (tube #1 to the pneumatic tube system, tube #2 to personnel transport) or Sequence B (tube #1 to personnel transport, tube #2 to the pneumatic tube system). The sequence is held in sealed, opaque, sequentially numbered envelopes that are opened in order at the time of enrolment. This scheme balances any effect of tube draw order across the two transport routes.
BLINDING (CONSORT 2025 Item 12b)
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. Clinicians and investigators are not blinded.
WITHDRAWAL CRITERIA
A participant's tube pair is withdrawn from analysis if pneumatic transport cannot be completed because of system failure, if a tube is broken or otherwise cannot be analyzed, or if the participant withdraws consent.
HARMS (CONSORT 2025 Item 27)
No intervention is applied to the participant. Both tubes are drawn from the venipuncture already required for routine clinical care, and no additional venipuncture or other invasive procedure is performed. No participant-level adverse events are therefore anticipated and no harms outcome measure is specified.
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.
120 studies on the registry are indexed under Hemolysis; 22 are open to participants now.
This study's planned enrollment of 166 is above the median of 49 across 78 interventional studies indexed under Hemolysis.
Browse Hemolysis studies →Marmara University Pendik Training and Research Hospital is the lead sponsor of 34 studies on the registry; 15 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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).
Time frame: At laboratory analysis (within 30 minutes of blood draw)
Rate of Clinically Significant Hemolysis (HI ≥ 1) in PTS-Transported vs. Personnel-Transported Tubes
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.
Time frame: At laboratory analysis (within 30 minutes of blood draw)
Spearman Correlation Between Tube Transport Time and HI Category
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.
Time frame: At laboratory analysis (within 30 minutes of blood draw)
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
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.
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Marmara University Pendik Training and Research Hospital