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临床试验/NCT07755007
NCT07755007招募中不适用

Pneumatic Tube System Versus Personnel Transport and the Hemolysis Index of Emergency Department Blood Samples: A Randomized, Split-Sample, Single-Blind Trial

Marmara University Pendik Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
166
试验地点
1
主要终点
Hemolysis Index (HI) Category in PTS-Transported vs. Personnel-Transported Tubes

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Pneumatic Tube System Transport (Procedure)

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.

干预措施: Manual Personnel Transport (Procedure)

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.

干预措施: Pneumatic Tube System Transport (Procedure)

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.

干预措施: Manual Personnel Transport (Procedure)

结局指标

主要结局

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

时间窗: 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).

次要结局

  • Rate of Clinically Significant Hemolysis (HI ≥ 1) in PTS-Transported vs. Personnel-Transported Tubes(At laboratory analysis (within 30 minutes of blood draw))

研究者

发起方
Marmara University Pendik Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emir Ünal

Assistant Professor

Marmara University Pendik Training and Research Hospital

研究点 (1)

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