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NCT Number: NCT07007585

Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection

This 3-year prospective observational study aims to identify clinical and laboratory risk factors associated with hospitalization in patients with confirmed dengue virus infection. It also seeks to analyze real-world transfusion practices and their outcomes. The study will be conducted in a second-level hospital in northern Mexico and will follow patients from emergency department entry to clinical resolution or hospital discharge.

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Key information

Conditions

Dengue Arbovirus Infections Blood Platelet Disorders Cytopenia Dengue Fever Dengue Fever With Warning Signs Flaviviridae Infections Flavivirus Infections Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Thrombocytopenia Vector Borne Diseases Virus Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Mexico

Piedras Negras, Coahuila, 26000, Mexico

Location status: Recruiting

About this study

This study will prospectively follow patients over 3 years to determine the relationship between clinical/laboratory variables and outcomes such as hospitalization and transfusion need. It seeks to improve understanding of real-world decision-making in transfusions for dengue-related thrombocytopenia and refine current hospitalization criteria based on locally observed predictors.

Patients will be enrolled consecutively at emergency departments or outpatient clinics with confirmed dengue infection. Clinical data (fever duration, bleeding signs, vomiting, abdominal pain, platelet count, hematocrit) and transfusion records will be collected and analyzed to identify independent predictors using multivariate logistic regression.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥5 years
  • Laboratory-confirmed dengue infection (NS1, IgM, or PCR)
  • First contact at emergency or outpatient services
  • Informed consent signed by the patient or legal guardian

Exclusion criteria

  • Co-infection with other arboviruses or COVID-19
  • Pre-existing hematologic or oncologic disease
  • Refusal to sign informed consent

Treatment and study plan

Primary outcomes

  1. Proportion of enrolled patients requiring hospitalization

    Time frame: Time Frame: Within 10 days of symptom onset

    The proportion of patients with laboratory-confirmed dengue infection who require hospitalization will be recorded. Hospitalization is defined as admission to the inpatient ward or intensive care unit for ≥24 hours due to dengue-related clinical indications.

    Unit of Measure:

    Percentage of participants (%)

  2. Clinical and laboratory risk factors associated with hospitalization

    Time frame: Within 10 days of symptom onset

    Description:

    Among patients who are hospitalized, relevant clinical signs (e.g., persistent vomiting, mucosal bleeding, abdominal pain) and laboratory parameters (e.g., platelet count, hematocrit rise, leukopenia) will be analyzed to identify independent predictors for hospitalization using multivariate regression.

    Unit of Measure:

    Odds ratio for each factor (as determined by statistical modeling)

Secondary outcomes

  1. Proportion of patients receiving blood product transfusion

    Time frame: Time Frame: Within 14 days

    The proportion of participants who receive any blood product transfusion (platelets, red cells, plasma) will be documented. Transfusions must be indicated for dengue-related complications and recorded in the patient file.

    Unit of Measure:

    Percentage of participants (%)

  2. Criteria for transfusion used by attending physicians

    Time frame: Within 14 days of symptom onset

    Documented clinical and laboratory criteria used to justify transfusion (e.g., platelet count < 20,000/μL with bleeding, hemodynamic instability, or major hemorrhage) will be analyzed descriptively. No interventions will be assigned by the study team.

    Unit of Measure:

    Proportion of cases using each transfusion criterion (%)

Other outcomes

  1. ICU admission or mortality

    Time frame: Time Frame: 30 days

    Proportion of patients who require intensive care unit admission or who die during the course of illness will be recorded to characterize disease severity.

    Unit of Measure:

    Percentage of participants (%)

Study contacts

Contact information is provided by the study sponsor or research team.

JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD, MSc, Ph, Specialist

CONTACT

[email protected]

525525848735

Sponsors and collaborators

Lead sponsor

Jose Ivan Rodriguez de Molina Serrano

Other

Registry information

Official study title

Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection: A Prospective Observational Study

Acronym: DENGUE-FACT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 6, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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