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临床试验/CTRI/2025/02/080752
CTRI/2025/02/080752尚未招募不适用

Assessment of Platelet Indices and Leukocyte Count Alterations Pre- and Post-Platelet Transfusion in Hospitalized Dengue Patients

Dr Chandrasekar M1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2025年3月3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
121
试验地点
1
主要终点
The primary outcome of the study is to evaluate the changes in platelet indices (Platelet Count [PC], Mean Platelet Volume [MPV], Platelet Distribution Width [PDW], Plateletcrit [PCT], and Platelet-Large Cell Ratio [P-LCR]) before and after platelet transfusion in hospitalized dengue patients.

研究概览

简要总结

The study titled "Assessment of Platelet Indices and Leukocyte Count Alterations Pre- and Post-Platelet Transfusion in Hospitalized Dengue Patients" investigates the hematological changes associated with platelet transfusion in dengue patients. Dengue, a mosquito-borne viral infection, often leads to severe thrombocytopenia (low platelet count), necessitating platelet transfusions to manage bleeding risks.

This research focuses on evaluating platelet indices (platelet count, mean platelet volume, platelet distribution width, and plateletcrit) and leukocyte count alterations before and after platelet transfusion. By analyzing these parameters, the study aims to determine the efficacy and physiological response to transfusion therapy in dengue patients.

The study employs both manual and automated methods for measuring platelet and leukocyte parameters, including WBC morphology. It aims to determine the effectiveness of these methods in capturing hematological changes and resolving challenges like the inability of automated analyzers to accurately count giant platelets. Morphological changes in WBCs, such as hypersegmented neutrophils, reactive lymphocytes, and toxic granules, will also be analyzed to understand their potential as predictors of hematological response and transfusion-related complications.  An increase in the platelet-to-WBC ratio (PWR) will correlate with faster recovery and shorter hospital stays.

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

  • Patients diagnosis with dengue fever, Dengue Hemorrhagic Fever or Dengue Sock Syndrome as per WHO criteria
  • Patients who are hospitalized for dengue management in the tertiary care hospital.
  • Patients aged 18 years and above.
  • Patients who have received one platelet transfusion.
  • Patients or their legal guardians, who provide written informed consent to participate in the study.

排除标准

  • Other Infections like malaria, typhoid that could affect hematological parameters done by Fever profile.
  • Patients with pre-existing chronic hematological disorders (e.g., leukemia, aplastic anemia) that confound results.
  • Below 18 years old age individuals due to the distinct physiological differences between children and adults.
  • Patients on immunosuppressive therapy or chemotherapy, as these treatments can affect leukocyte counts and platelet indices.
  • Pregnant women, due to the physiological changes in hematological parameters during pregnancy.
  • Patients with severe chronic diseases (e.g., end-stage renal disease, severe liver cirrhosis) that could impact hematological parameters and recovery.

结局指标

主要结局

The primary outcome of the study is to evaluate the changes in platelet indices (Platelet Count [PC], Mean Platelet Volume [MPV], Platelet Distribution Width [PDW], Plateletcrit [PCT], and Platelet-Large Cell Ratio [P-LCR]) before and after platelet transfusion in hospitalized dengue patients.

时间窗: 1 Year

次要结局

  • 1. Analyzing changes in leukocyte count and platelet-to-WBC ratio (PWR) pre- and post-transfusion and their association with recovery outcomes.(2. Identifying morphological changes in white blood cells (e.g., hypersegmented neutrophils, reactive lymphocytes, toxic granules) as potential predictors of hematological response and complications following platelet transfusion.)

研究者

发起方
Dr Chandrasekar M
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Chandrasekar M

Galgotias University, Greater Noida, Uttar Pradesh

研究点 (1)

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