HemolysisPTS-HEMO-EDNCT07755007
Pneumatic Tube System Versus Personnel Transport and the Hemolysis Index of Emergency Department Blood Samples: A Randomized, Split-Sample, Single-Blind Trial
A study testing Pneumatic Tube System Transport and Manual Personnel Transport in people with Hemolysis and Diagnostic Errors, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemolysis, Diagnostic Errors, Blood Specimen Collection
- What is being tested?
- Pneumatic Tube System Transport and Manual Personnel Transport
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, allowing two yellow-cap (serum separator) tubes to be drawn from the same venipuncture
- Written informed consent provided by the participant or, where the acute clinical condition of the participant prevents this, by a legal representative
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emir Ünal, Assistant Professor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul, Pendik, 34899
Emir Ünal, 05327766010, emirunal@gmail.com
About this 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, 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.
Read the 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.
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.
- Conditions
- Hemolysis, Diagnostic Errors, Blood Specimen Collection
- Being tested
- Pneumatic Tube System Transport, Manual Personnel Transport
- Keywords
- Pneumatic Tube System, Blood Specimen Transport, Hemolysis Index, Emergency Service, Hospital, Pre-Analytical Variability, Sumetzberger
- Medical subject headings
- Hemolysis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic Tube System TransportProcedure or surgery
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 TransportProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PTS-First Sequence | Other | 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. Receives: Procedure: Pneumatic Tube System Transport; Procedure: Manual Personnel Transport |
| Personnel-First Sequence | Other | 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. Receives: Procedure: Pneumatic Tube System Transport; Procedure: Manual Personnel Transport |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: At laboratory analysis (within 30 minutes of blood draw)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Sep 2026
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HemolysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emir Ünal, Marmara University Pendik Training and Research Hospital
- Investigators
- Emir Ünal, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755007
- Sponsor's protocol ID
- MU-KAEK-2026-09.2029.26-0645
- Acronym
- PTS-HEMO-ED
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Mullins GR, Bruns DE. Air bubbles and hemolysis of blood samples during transport by pneumatic tube systems. Clin Chim Acta. 2017 Oct;473:9-13. doi: 10.1016/j.cca.2017.08.008. Epub 2017 Aug 10.
PubMed 28803746Kara H, Bayir A, Ak A, Degirmenci S, Akinci M, Agacayak A, Marcil E, Azap M. Hemolysis associated with pneumatic tube system transport for blood samples. Pak J Med Sci. 2014 Jan;30(1):50-8. doi: 10.12669/pjms.301.4228.
PubMed 24639830Cakirca G, Erdal H. The Effect of Pneumatic Tube Systems on the Hemolysis of Biochemistry Blood Samples. J Emerg Nurs. 2017 May;43(3):255-258. doi: 10.1016/j.jen.2016.09.007. Epub 2017 Mar 28.
PubMed 28359708Phelan MP, Reineks EZ, Hustey FM, Berriochoa JP, Podolsky SR, Meldon S, Schold JD, Chamberlin J, Procop GW. Does Pneumatic Tube System Transport Contribute to Hemolysis in ED Blood Samples? West J Emerg Med. 2016 Sep;17(5):557-60. doi: 10.5811/westjem.2016.6.29948. Epub 2016 Jul 26.
PubMed 27625719Ding X, Wen X, Wang L, Chen T, Zhou G, He H, Xin X. Effects of a pneumatic tube system on the hemolysis of blood samples: a PRISMA-compliant meta-analysis. Scand J Clin Lab Invest. 2021 Sep;81(5):343-352. doi: 10.1080/00365513.2021.1930140. Epub 2021 Jun 10.
PubMed 34109899