Registry of dengue infection in people with congenital bleeding disorders

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

This registry will collect information to see how dengue affects people with congenital bleeding disorders, such as hemophilia and von Willebrand disease, and what treatments and outcomes occur.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Sex: All
• Sponsor: Mahidol University (Academic / other)
• Locations: 1 site (Bangkok)
• Trial ID: NCT07409857 on ClinicalTrials.gov

What this trial studies

This observational registry, led by Mahidol University, collects clinical and laboratory data on people with congenital bleeding disorders who develop dengue using WHO diagnostic criteria. Participants of any age with probable or definite dengue (clinical criteria, IgM/NS1/seroconversion or rising IgG) are included and data capture focuses on bleeding episodes, platelet counts, hemostatic parameters, replacement therapy use, and clinical outcomes. Data are entered by participating hospitals (currently Ramathibodi Hospital and collaborating sites) to describe patterns of bleeding, treatment practices, and mortality. The registry aims to clarify risk factors for severe bleeding and inform management recommendations for this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are people (age ≥ 1 day) with congenital bleeding disorders (for example hemophilia, von Willebrand disease, other factor deficiencies or platelet disorders) who have probable or confirmed dengue infection by WHO criteria.

Not a fit: Patients without congenital bleeding disorders or without current/probable dengue infection are unlikely to gain direct benefit from participation.

Why it matters

Potential benefit: If successful, the registry could help clinicians reduce bleeding complications and deaths by guiding better prevention and treatment for dengue in people with congenital bleeding disorders.

How similar studies have performed: There are few prior registries and only small cohorts or case reports describing dengue in people with bleeding disorders, which suggest higher bleeding risk and mortality, so this registry addresses a relatively understudied area.

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

Where this trial is running

Bangkok

• Ramathibodi Hospital — Bangkok, Thailand (Recruiting)

Study contacts

• Study coordinator: Nongnuch Sirachainan, MD

Conditions Dengue Disease; Dengue Haemorrhagic Fever; Dengue Fever; Dengue Fever With Warning Signs; Dengue; Congenital bleeding disorders; Replacement