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

NCT07409857 | Recruiting

• 2 other identifiers: 7249MURA2025/385
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dengue Disease; Dengue Haemorrhagic Fever; Dengue Fever; Dengue Fever With Warning Signs

Keywords

Dengue; Congenital bleeding disorders; Replacement

Outcome Measures

Primary Outcomes (3)

• 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

  Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)

• Amount of replacement therapy

  Percentage of patients receiving blood product, Percent of factor activity requirement during dengue infection

  Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)

• Mortality

  Percentage of mortality

  Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)

Secondary Outcomes (2)

• Severity of bleeding among congenital bleeding disorders

  Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)

• Mortality among congenital bleeding disorders

  Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)

Study Arms (1)

Dengue infection in patients with congenital bleeding disorders

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with congenital bleeding disorders of any age who have dengue infection

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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Ramathibodi Hospital

Bangkok, Thailand

RECRUITING

Related Publications (11)

• 1. World Health Organization. Disease Outbreak News Dengue Global Situation. Last modified December 21,2023 https://www.who.int/emergencies/disease-outbreak-news/item/2023-DON498#:~:text=After%20a%20slight%20decline%20of%20cases%20between%20the,scale%2C%20and%20simultaneous%20occurrence%20of%20multiple%20outbreaks%2C%20sprea

  BACKGROUND

• Krishnamurti C, Kalayanarooj S, Cutting MA, Peat RA, Rothwell SW, Reid TJ, Green S, Nisalak A, Endy TP, Vaughn DW, Nimmannitya S, Innis BL. Mechanisms of hemorrhage in dengue without circulatory collapse. Am J Trop Med Hyg. 2001 Dec;65(6):840-7. doi: 10.4269/ajtmh.2001.65.840.

  PMID: 11791984 BACKGROUND

• Wijayaratne D, Ranasinghe P, Mohotti SP, Dilrukshi SA, Katulanda P. Dengue fever in a patient with severe haemophilia: a case report. BMC Res Notes. 2015 Mar 12;8:78. doi: 10.1186/s13104-015-1043-x.

  PMID: 25889043 BACKGROUND

• Chuansumrit A, Tangnararatchakit K, Sirachainan N, Khositseth A, Kuptanon T, Wanitkun S, Withurawanit W, Songdej D. Dengue virus infection in haemophilic patients: aggravation of bleeding risk. Haemophilia. 2011 May;17(3):553-6. doi: 10.1111/j.1365-2516.2010.02413.x. Epub 2010 Nov 11. No abstract available.

  PMID: 21070495 BACKGROUND

• Sosothikul D, Thisyakorn U, Thisyakorn C. HEMOSTATIC STUDIES IN DENGUE PATIENTS. Southeast Asian J Trop Med Public Health. 2015;46 Suppl 1:43-5.

  PMID: 26506731 BACKGROUND

• Sosothikul D, Seksarn P, Pongsewalak S, Thisyakorn U, Lusher J. Activation of endothelial cells, coagulation and fibrinolysis in children with Dengue virus infection. Thromb Haemost. 2007 Apr;97(4):627-34.

  PMID: 17393026 BACKGROUND

• Chuansumrit A, Chaiyaratana W. Hemostatic derangement in dengue hemorrhagic fever. Thromb Res. 2014 Jan;133(1):10-6. doi: 10.1016/j.thromres.2013.09.028. Epub 2013 Sep 26.

  PMID: 24120237 BACKGROUND

• Chuansumrit A, Tangnararatchakit K, Sirachainan N, Pakakasamal S, Hongeng S, Chaiyaratana W, Kitpoka P, Yoksan S. Dengue infection in hematologic-oncologic pediatric patients: aggravation of anemia and bleeding risk. Southeast Asian J Trop Med Public Health. 2012 Mar;43(2):311-22.

  PMID: 23082583 BACKGROUND

• Gubler DJ. Dengue and dengue hemorrhagic fever. Clin Microbiol Rev. 1998 Jul;11(3):480-96. doi: 10.1128/CMR.11.3.480.

  PMID: 9665979 BACKGROUND

• Simmons CP, Farrar JJ, Nguyen vV, Wills B. Dengue. N Engl J Med. 2012 Apr 12;366(15):1423-32. doi: 10.1056/NEJMra1110265. No abstract available.

  PMID: 22494122 BACKGROUND

• Kalayanarooj S. Clinical Manifestations and Management of Dengue/DHF/DSS. Trop Med Health. 2011 Dec;39(4 Suppl):83-7. doi: 10.2149/tmh.2011-S10. Epub 2011 Dec 22.

  PMID: 22500140 BACKGROUND

Related Links

• Proposal, Data information, Ethic approval

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Central Study Contacts

Nongnuch Sirachainan, MD

CONTACT

+66865603103; nongnuch.sir@mahidol.ac.th

Sawitree Chawwapee

CONTACT

+6622011749; imdrunkcat@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 13, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-01

Locations

TH (1)