Blood Specimen Collection, Diagnostic Errors, Hemolysis
Conditions
Keywords
Pneumatic Tube System, Blood Specimen Transport, Hemolysis Index, Emergency Service, Hospital, Pre-Analytical Variability, Sumetzberger
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.
Detailed description
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.
Interventions
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.
Sponsors
Study design
Masking description
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.
Intervention 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.
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemolysis Index (HI) Category in PTS-Transported vs. Personnel-Transported Tubes | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of Clinically Significant Hemolysis (HI ≥ 1) in PTS-Transported vs. Personnel-Transported Tubes | 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. |
Countries
Turkey (Türkiye)
Contacts
Marmara University