Registry of dengue infection in people with congenital bleeding disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ramathibodi Hospital
  Bangkok, Thailand Recruiting

Study contacts

• Study coordinator: Nongnuch Sirachainan, MD
• Email: nongnuch.sir@mahidol.ac.th
• Phone: +66865603103

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.