Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5+
SponsorJose Ivan Rodriguez de Molina Serrano
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Co-infection with other arboviruses or COVID-19
Pre-existing hematologic or oncologic disease
Refusal to sign informed consent
Trial population
The study population consists of patients with confirmed dengue virus infection who seek care at Clínica México, a second-level hospital located in Piedras Negras, Coahuila, Mexico. Participants will be enrolled from both the emergency department and outpatient services. The hospital primarily serves an urban and peri-urban population from northern Coahuila and bordering rural areas. This setting allows for the inclusion of a broad range of clinical presentations, from mild outpatient cases to severe dengue requiring hospitalization or intensive care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Inpatient Confirmed Dengue Cohort
Trial outcomes
Primary outcomes
1
Proportion of enrolled patients requiring hospitalization
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 (%)
Time frame
Time Frame: Within 10 days of symptom onset2
Clinical and laboratory risk factors associated with hospitalization
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)
Time frame
Within 10 days of symptom onsetSecondary outcomes
1
Proportion of patients receiving blood product transfusion
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 (%)
Time frame
Time Frame: Within 14 days2
Criteria for transfusion used by attending physicians
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 (%)
Time frame
Within 14 days of symptom onsetOther outcomes
1
ICU admission or mortality
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 (%)
Time frame
Time Frame: 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jose Ivan Rodriguez de Molina Serrano
Lead sponsor
Clinica Mexico
Sponsor institution
Source ClinicalTrials.gov