跳至主要内容
临床试验/NCT05004844
NCT05004844Unknown不适用

Mitochondrial Dysfunction in Trauma-related Coagulopathy - Is There Causality? - Study Protocol for a Prospective Observational Study

Petra Hartmann MD Ph.D.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年10月31日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Association between mitochondrial functions and aggregation capacity of platelets

研究概览

简要总结

Bleeding control often poses a great challenge for clinicians due to trauma-induced blood clotting disorder (TIC), a condition that is present in one-third of bleeding trauma patients. As platelets are considered as central mediators in TIC, the understanding of mitochondria-mediated processes in thrombocytes may disclose new therapeutic targets in the management of severely injured patients. The investigators hypothesize that mitochondrial dysfunction occurs in the platelets of trauma patients with TIC. The investigators intend to quantitatively characterize the derangements of mitochondrial functions in TIC; and assess the relation between mitochondrial respiration and clinical markers of platelet function

详细描述

Hemorrhage control often poses a great challenge for clinicians due to trauma-induced coagulopathy (TIC), a condition that is present in one-third of bleeding trauma patients. As platelets are considered as central mediators in TIC, the understanding of mitochondria-mediated processes in thrombocytes may disclose new therapeutic targets in the management of severely injured patients. The investigators hypothesize that mitochondrial dysfunction occurs in the platelets of trauma patients with TIC. The investigators intend to quantitatively characterize the derangements of mitochondrial functions in TIC; and assess the relation between mitochondrial respiration and clinical markers of platelet function measured with aggregometry, viscoelastic tests and conventional laboratory analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Trauma patients
  • Injury Severity Score (ISS) 16 or greater,
  • age of 18 years or greater,
  • hemorrhage confirmed with extended focused assessment with sonography in trauma (eFAST) or computer tomography (CT)

排除标准

  • 未提供

结局指标

主要结局

Association between mitochondrial functions and aggregation capacity of platelets

时间窗: 72 hours

The association between the results of high-resolution respirometry (The activity of respiratory complexes, the ATP synthase activity (OxPhos), the electron transport chain capacity and coupling of mitochondria) and numerical parameters of ROTEM aggregometry (AUC, MS and A6 in TRAPTEM) at 0, 24, 48, and 72 hours post-admission will constitute our primary outcome.

次要结局

  • Relation between platelet mitochondrial functions and mortality(72 hours)
  • Association between platelet mitochondrial functions and clot formation ability(72 hours)
  • Association between platelet mitochondrial functions and conventional laboratory markers of hemostasis(72 hours)

研究者

发起方
Petra Hartmann MD Ph.D.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Petra Hartmann MD Ph.D.

Associate Professor

Szeged University

研究点 (1)

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