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临床试验/NCT06097429
NCT06097429已完成不适用

Evaluation of Platelet Aggregation in COVID-19 Patients

Mansoura University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Mortality rate.

研究概览

简要总结

Context: Hypercoagulable state associated with COVID-19 is one of the pathologic events that noticed in different waves of COVID-19 pandemics and leads to serious consequences in mortality and morbidity Aim: To evaluate platelet aggregation using light-transmission aggregometry and adenosine diphosphate (ADP) as an agonist in COVID-19 patients.

Settings and design: This was prospective cross-sectional study. Patients and methods: Seventy-five individuals were enrolled in this study and divided into two groups, 50 patients with PCR-positive COVID-19 as study group and 25 apparently healthy individual as a control group. All individuals were subjected to full clinical evaluation, CT-chest, laboratory investigations: CBC, INR, LDH, CRP, serum ferritin and platelet aggregation evaluation using light-transmission aggregometry and adenosine diphosphate (ADP) as an agonist

详细描述

This observational, case control study included 50 adult patients with positive COVID-19 PCR test recruited from isolation department of Mansoura university hospital from July 2021 to May 2022 as a study group, and control group included 25 healthy persons with no history nor symptoms of COVID -19 and negative PCR test, matched with the study group regarding the demographic variables and comorbidities.

The protocol of this study was approved by the Institutional Research Board of Faculty of Medicine, Mansoura University (code no: MS.21.07.1596) and written informed consents were obtained from all patients to be enrolled in this study.

The aim of this study was to evaluate platelet aggregation using light-transmission aggregometry and adenosine diphosphate (ADP) as an agonist in COVID-19 patients, in comparison to that in healthy controls.

Patients:

Inclusion criteria:

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Age ≥ 18 years old.

排除标准

  • • Patients with thrombocytopenia and thrombocytosis defined as platelet count less than 100,000/ µL, count more than 450,000 / µL respectively
  • Patients with hematocrit abnormalities as less than 34% or greater than 55%
  • Patients with disseminated intravascular coagulation (DIC)
  • Active malignancy
  • Liver disease as such chronic hepatitis, cirrhosis or liver cell failure.
  • Any hematological disorders as hemophilia or thalassemia.
  • Patients on invasive mechanical ventilation as endotracheal intubation and mechanical ventilation itself are factors for having a higher mean platelet volume (MPV) which means that platelets are larger than average which are more adhesive and likely to aggregate in vitro. Patients receiving aspirin, non-steroidal anti-inflammatory drugs, antiplatelet drugs or any other medications that can influence platelet function (14 days prior to blood sample collection)

结局指标

主要结局

Mortality rate.

时间窗: day 0 to day 30

recording from any mortality from the study and the control group

次要结局

  • Developing new thromboembolic event as arterial or venous thrombosis(day 0 to day 30)
  • Need to invasive mechanical ventilation (MV)(day 0 to day 30)
  • Length of hospital stay (days)(day 0 to day 30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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