International Registry of Dengue Infection in Congenital Bleeding Disorders (DengueCBDR)

Recruiting now

Conditions studied: Dengue Disease, Dengue Haemorrhagic Fever, Dengue Fever, Dengue Fever With Warning Signs

In brief

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.

Key facts

Study ID

NCT07409857

Run by

Mahidol University

People needed

100

Starts

2025-12-01

Expected to finish

2030-12-31

Last updated by the study team

2026-02-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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):
• Increase Hct at least 15-20% from baseline
• Serum albumin < 35 g/L
• Presence of pleural effusion or ascites
• Dengue shock syndrome:
• Narrow pulse pressure (< 20 mmHg)
• Hypotension
• 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

You may not qualify if…

• Patients with CBDs with dengue infection who are not willing to participate in the study

Where it is running

• Ramathibodi Hospital — Bangkok, Thailand (enrolling)

Full record on ClinicalTrials.gov

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