NCT07409857 International Registry of Dengue Infection in Congenital Bleeding Disorders (DengueCBDR)
| NCT ID | NCT07409857 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mahidol University |
| Condition | Dengue Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-12-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: Patients, aged ≥ 1 day old, diagnosed with CBDs (e.g., hemophilia, von Willebrand disease, and other coagulation factor deficiency) who are diagnosed with dengue infection, based on WHO criteria as follow; Clinical dengue infection: Symptoms of high sustained fever for 3-7 days with 2 of the following: headache, retroorbital pain, myalgia, arthralgia/bone pain, hemorrhagic manifestation, positive tourniquet test, leukopenia (WBC ≤5000/uL) Probable dengue infection: Positive dengue IgM Definite dengue infection: Seroconversion of dengue IgM between acute and convalescent serum OR Rising of dengue IgG (HAI) at least 4 folds between acute and convalescent serum OR Positive NS1 Ag or other dengue-specific antigen tests Dengue hemorrhagic fever: Dengue infection with signs of bleeding (including positive tourniquet test) with platelet count \< 100,000/uL and with signs of leakage (one of the following): 1. Increase Hct at least 15-20% from baseline 2. Serum albumin \< 35 g/L 3. Presence of pleural effusion or ascites Dengue shock syndrome: 1. Narrow pulse pressure (\< 20 mmHg) 2. Hypotension 3. Signs of poor tissue perfusion Severity of DHF: * Grade I: Positive tourniquet test * Grade II: Spontaneous bleeding * Grade III: Circulatory failure (narrow pulse pressure ≤20 mmHg, hypotension, or signs of poor tissue perfusion) * Grade IV: Profound shock with undetectable blood pressure Exclusion Criteria: * Patients with CBDs with dengue infection who are not willing to participate in the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07409857 clinical trial?
This trial is open to participants of all sexes, studying Dengue Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07409857 currently recruiting?
Yes, NCT07409857 is actively recruiting participants. Contact the research team at nongnuch.sir@mahidol.ac.th for enrollment information.
Where is the NCT07409857 trial being conducted?
This trial is being conducted at Bangkok, Thailand.
Who is sponsoring the NCT07409857 clinical trial?
NCT07409857 is sponsored by Mahidol University. The trial plans to enroll 100 participants.