International Registry of Dengue Infection in Congenital Bleeding Disorders (DengueCBDR)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMahidol University
About this trial
Dengue fever, a viral infection transmitted by Aedes mosquitoes, is a major health issue in tropical and subtropical regions. Around 20-30% of symptomatic patients developed Dengue Hemorrhagic Fever (DHF), which leads to impaired hemostasis, subsequently increasing the risk of bleeding.
The hemostatic abnormalities associated with dengue infection included vascular permeability, platelet dysfunction, and coagulation defects. Therefore, Individuals with underlying bleeding disorders are at increased risk of bleeding. Dengue infection in patients with hemophilia was reported, including six of 843 patients in the cohort with underlying hemophilia: five with hemophilia A and one with hemophilia B. Replacement therapy was more commonly used in patients with bleeding disorders and dengue than in patients with other febrile illnesses. All of them had bleeding during dengue infection. The mortality rate was high at 16%.
Despite the importance of this issue, there is a lack of registries or data-collection systems to determine the bleeding complications, the requirement for replacement therapy, and the outcome of dengue infection in congenital bleeding disorders (CBDs). Therefore, this research aims to establish a registry of dengue infections among individuals with CBDs.
The study is a multicenter, retrospective study from 1 January 2015 to 31 December 2025 and a prospective cohort study involving hospitals that treat individuals with CBDs and dengue. The registry format will be provided using REDCap system.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Increase Hct at least 15-20% from baseline
Serum albumin < 35 g/L
Presence of pleural effusion or ascites
Narrow pulse pressure (< 20 mmHg)
Disqualifiers
Patients with CBDs with dengue infection who are not willing to participate in the study
Trial population
Patients with congenital bleeding disorders of any age who have dengue infection
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Dengue infection in patients with congenital bleeding disorders
Trial outcomes
Primary outcomes
1
Severity of Bleeding
Percentage of major and clinically relevant non-major bleeding (CRNMB) Major bleeding: Fatal bleeding, clinically overt bleeding associated with a decrease in Hgb of at least 20 g/L (2 g/ dL) in a 24-hour period, critical site bleeding such as retroperitoneal, pulmonary, pericardial, intracranial, or otherwise involves the central nervous system, bleeding that requires an intervention via an invasive procedure such as surgery in an operating suite, interventional radiology, or endoscopy Clinically relevant non-major bleeding (CRNMB): Bleeding that results in a medical or procedural intervention not meeting major bleeding criteria, examples include: hormonal therapy, tranexamic acid (TXA), iron, nasal packing, nasal cautery, laparoscopic arthroscopic retrograde cholangiopancreatography (LARC) placement, bleeding that results in hospitalization or increased level of care, overt bleeding for which a blood product is administered, and does not meet criteria for major bleeding
Time frame
Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)2
Amount of replacement therapy
Percentage of patients receiving blood product, Percent of factor activity requirement during dengue infection
Time frame
Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)3
Mortality
Percentage of mortality
Time frame
Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)Secondary outcomes
1
Severity of bleeding among congenital bleeding disorders
Compared percentage of severity of bleeding between hemophilia and other bleeding disorders
Time frame
Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)2
Mortality among congenital bleeding disorders
Compared percentage of mortality outcome between hemophilia and other bleeding disorders
Time frame
Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)Sponsors and contacts
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Source ClinicalTrials.gov