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气动管道系统对脓毒症患者和健康个体黏弹性凝血试验的影响:随机对照VETaPT试验方案

Effects of pneumatic tube systems on viscoelastic coagulation tests in septic patients and healthy individuals: protocol of the randomized controlled VETaPT-trial.

作者信息

Mirus Martin, Buehrer Erik, Heubner Lars, Schnabel Christian, Koch Thea, Spieth Peter Markus

机构信息

Department of Anaesthesiology and Intensive Care Medicine, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.

出版信息

Front Med (Lausanne). 2025 Jun 10;12:1613276. doi: 10.3389/fmed.2025.1613276. eCollection 2025.

DOI:10.3389/fmed.2025.1613276
PMID:40557045
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12185529/
Abstract

INTRODUCTION

Rapid coagulation assessment is crucial in emergencies, especially with acute bleeding, where timely intervention prevents shock and circulatory failure. Viscoelastic tests (VET) offer real-time insights into clot formation, fibrinolysis, and overall coagulation dynamics, often surpassing conventional lab tests. To accelerate diagnostics, hospitals use pneumatic tube systems (PTS) for blood transport. However, the effect of PTS transport on VET results remains unclear, especially with newer VET technologies and in critically ill patients, who may be more vulnerable to acceleration forces.

OBJECTIVE

The VETaPT (Viscoelastic Testing after Pneumatic Tube Transport) trial investigates whether PTS transport influences results of three next generation VET and platelet function testing in healthy volunteers and critically ill septic patients. It explores if acceleration during transport alters coagulation and platelet function parameters and whether septic patients exhibit increased susceptibility due to their altered coagulation profiles. A goal is to define an acceleration threshold above which PTS-related effects become clinically relevant. This threshold could allow assessment of transport suitability based on force data alone, supporting wider clinical application without repeated blood testing.

STUDY DESIGN

This prospective, randomized clinical trial includes both healthy volunteers and critically ill septic patients. Paired blood samples are collected and randomly assigned to either manual or PTS transport, with each subject serving as their own control. Acceleration forces during PTS transport are continuously recorded using a three-axis accelerometer. Samples are analyzed using standard lab tests and following point-of-care devices: ClotPro, ROTEM sigma, Multiplate, and TEG6s. The primary outcome is the difference in coagulation parameters between transport methods, evaluated in the context of measured acceleration forces.

EXPECTED RESULTS

This is the first study to systematically compare multiple next generation VET and platelet aggregation systems in both healthy and septic patients under controlled PTS transport conditions. It is hypothesized that PTS-induced acceleration may alter test results. Identifying a critical threshold could ensure safe, rapid blood transport without compromising diagnostic quality, potentially reducing personnel needs and expediting therapy initiation.

REGISTRATION

Ethics approval was obtained from the responsible committee of the Technical University Dresden (BO-EK-12012024_1). The study is registered with the German Clinical Trials Register (DRKS00036231).

摘要

引言

快速凝血评估在紧急情况下至关重要,尤其是在急性出血时,及时干预可预防休克和循环衰竭。粘弹性测试(VET)能实时洞察凝血块形成、纤维蛋白溶解及整体凝血动力学,常常优于传统实验室检测。为加快诊断速度,医院使用气动管道系统(PTS)进行血液传输。然而,PTS传输对VET结果的影响仍不明确,特别是对于更新的VET技术以及危重症患者,他们可能对加速力更为敏感。

目的

VETaPT(气动管道传输后的粘弹性测试)试验旨在研究PTS传输是否会影响健康志愿者和危重症脓毒症患者的三种下一代VET及血小板功能检测结果。该试验探讨传输过程中的加速是否会改变凝血和血小板功能参数,以及脓毒症患者因其改变的凝血谱是否表现出更高的易感性。目标是确定一个加速阈值,超过该阈值后与PTS相关的影响将具有临床相关性。此阈值可仅根据力数据评估传输适用性,支持更广泛的临床应用而无需重复血液检测。

研究设计

这项前瞻性随机临床试验纳入了健康志愿者和危重症脓毒症患者。采集配对的血样并随机分配至手动传输或PTS传输,每位受试者作为自身对照。使用三轴加速度计持续记录PTS传输过程中的加速力。样本采用标准实验室检测以及即时检测设备进行分析:ClotPro、ROTEM sigma、Multiplate和TEG6s。主要结局是传输方法之间凝血参数的差异,并结合测量的加速力进行评估。

预期结果

这是第一项在受控的PTS传输条件下,系统比较健康和脓毒症患者中多种下一代VET及血小板聚集系统的研究。据推测,PTS诱导的加速可能会改变检测结果。确定一个关键阈值可确保安全、快速的血液传输,同时不影响诊断质量,有可能减少人员需求并加快治疗启动。

注册情况

已获得德累斯顿工业大学负责委员会的伦理批准(BO-EK-12012024_1)。该研究已在德国临床试验注册中心(DRKS00036231)注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c805/12185529/17225737b37b/fmed-12-1613276-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c805/12185529/f79b0923b96d/fmed-12-1613276-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c805/12185529/60a7f9a38b04/fmed-12-1613276-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c805/12185529/17225737b37b/fmed-12-1613276-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c805/12185529/f79b0923b96d/fmed-12-1613276-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c805/12185529/60a7f9a38b04/fmed-12-1613276-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c805/12185529/17225737b37b/fmed-12-1613276-g003.jpg

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