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临床试验/CTRI/2025/08/093226
CTRI/2025/08/093226尚未招募不适用

New-onset thrombocytopenia in critically ill sepsis patients: A cross-sectional observational study

School of Medical Sciences Research Sharda University1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2025年8月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
95
试验地点
1
主要终点
Evaluating the prevalence of thrombocytopenia in sepsis patients

研究概览

简要总结

The study aims to evaluate the prevalence, risk factors, causes, and outcomes of new-onset thrombocytopenia among ICU patients with sepsis. Thrombocytopenia, defined as a platelet count below 150,000/mm³, is a frequent hematological abnormality in critically ill patients, particularly in sepsis, with an incidence ranging from 13% to 60%. It can result from decreased platelet production, increased destruction, or sequestration, and in septic patients, is associated with poor prognosis including higher acute kidney injury rates, prolonged vasopressor use, extended ICU stays, major bleeding, and increased mortality. The study will be conducted from June 2025 to December 2026 in the ICU of Sharda Hospital as a hospital-based cross-sectional observational study. Based on prior research indicating a 47% incidence in septic patients, the calculated sample size is 95 patients. Adults over 18 years with sepsis, as defined by SOFA score criteria, will be included, while patients who refuse consent, those under 18, with hematological malignancies, or who are pregnant will be excluded. Data will be collected through daily evaluations, CBC with platelet count monitoring, sepsis severity scoring, assessment of organ dysfunctions, infection source identification, medication review, and outcome measures including ICU stay, ventilation duration, and mortality. Ethical clearance has been obtained, informed consent will be taken from legal representatives, and participation will be free of cost, with minimal risk from blood sampling. Previous literature, such as Venkata et al. (2013) and Sharma et al. (2007), has shown high thrombocytopenia incidence in septic patients and strong associations with worse outcomes, with unresolved thrombocytopenia significantly increasing mortality. This study seeks to further clarify these associations and identify key predictors in the local ICU population.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All adult of both genders patients with sepsis based on SOFA score.

排除标准

  • Patients’ attendant refusing consent or patients with hematological malignancies and pregnant patients.

结局指标

主要结局

Evaluating the prevalence of thrombocytopenia in sepsis patients

时间窗: 0, 1 year

次要结局

  • Identifying risk factors for thrombocytopenia in sepsis patients(1 year)
  • Identifying the causes of thrombocytopenia in sepsis patients(1 year)
  • Assessing the outcome of patients with sepsis(1 year)

研究者

发起方
School of Medical Sciences Research Sharda University
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Shreya Sharma

Sharda School of Medical Sciences & Research

研究点 (1)

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