Dengue DiseaseDengueCBDRNCT07409857
International Registry of Dengue Infection in Congenital Bleeding Disorders (DengueCBDR)
An observational study of Dengue Disease and Dengue Haemorrhagic Fever, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dengue Disease, Dengue Haemorrhagic Fever, Dengue Fever
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2025to 31 Dec 2030
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with congenital bleeding disorders of any age who have dengue infection
Who may be able to join
- 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:
Show all 21Show fewer
- 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
Who cannot join
- Patients with CBDs with dengue infection who are not willing to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Ramathibodi Hospital
Bangkok
Nongnuch Sirachainan, MD, +66865603103, nongnuch.sir@mahidol.ac.th
About this study
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%.
Read more
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.
Read the detailed description
Background:
The global incidence of dengue has markedly increased over the past two decades, posing a substantial public health challenge. From 2000 to 2019, the World Health Organization (WHO) documented a tenfold surge in reported cases worldwide, increasing from 500,000 to 5.2 million, with reported instances spreading across 129 countries.
Dengue fever, a viral infection transmitted by Aedes mosquitoes, is a major health issue in tropical and subtropical regions. Dengue virus (DENV) causes systemic infection in 25% of infected individuals. The symptoms include fever, rash, and, in severe cases, hemorrhagic manifestations. Around 20-30% of symptomatic patients developed Dengue Hemorrhagic Fever (DHF), which leads to increased vascular permeability, thrombocytopenia, and coagulopathy, which are known to increase the risk of bleeding. The most serious presentation is Dengue Shock Syndrome (DSS), which can cause substantial morbidity and mortality, particularly in vulnerable populations. One such vulnerable group is individuals with congenital bleeding disorders (CBDS), such as hemophilia, von Willebrand disease (vWD), platelet disorders, and other coagulation factor deficiencies.
Individuals with CBD have an inherent predisposition to bleeding complications, which could be exacerbated by the platelet dysfunction and vascular leakage associated with dengue infection. In addition, the interaction between the pathophysiology of dengue and bleeding disorders creates significant challenges in the diagnosis, management, and treatment of these individuals. Despite the importance of this issue, there is a lack of comprehensive registries or data-collection systems that track the incidence and outcomes of dengue infection among individuals with congenital bleeding disorders.
Dengue infection in patients with hemophilia was reported. A total of six patients in a cohort of 843 patients had underlying hemophilia; five with hemophilia A and one with hemophilia B. Replacement therapy was higher in patients with bleeding disorders with dengue, compared to other febrile illnesses. All of them had bleeding during dengue infection. The mortality rate was 16%. In addition, severe hemophilia patients presented with bleeding during the febrile stage while the platelet count was normal, then required factor replacement therapy. However, there is limited data on bleeding severity, replacement or prophylaxis protocols, and outcomes for this population.
This research aims to establish a registry of dengue infections among individuals with CBDs to understand bleeding complications, management, and outcomes of these patients. The registry will gather data on the clinical course, complications, management strategies, and outcomes of dengue infection in this population.
Primary Objective:
- To develop a registry of dengue infections in individuals with CBDs.
- To evaluate the bleeding complications, replacement therapy and outcomes of dengue infections in individuals with CBDs.
Secondary Objectives (if any):
To compare bleeding severity and outcome among types of bleeding disorders
Study design/methodology:
An international multicenter, retrospective, from 1 January 2015 to 31 December 2025, and prospective cohort study, involving hospitals that treat individuals with CBDs with dengue infection. The registry format will be provided using a REDCap system
Study Population:
Inclusion Criteria
Patients, aged ≥ 1 day old, diagnosed with CBDs (e.g., hemophilia, Von Willebrand disease, and other coagulation factor deficiency) who are diagnosed dengue infection, based on WHO criteria
Exclusion Criteria
Patients with CBDs with dengue infection who are not willing to participate the study
Registration information (include in the document link)
PART A: General information
Age at diagnosis.......year.........month
Sex
Underlying inherited bleeding disorder: Hemophilia, Coagulation factor deficiency, Platelet disorders, von Willebrand disease Prophylaxis: Factor dose and frequency
PART B: Dengue infection
Diagnosis: Clinical, probable, definite, uncertain (criteria is defined) Onset of presentation Fever Bleeding symptoms Replacement therapy during dengue infection Febrile stage Toxic (leakage, shock) stage Recovery
Outcome Survive Improved without sequelae Improved with sequelae Death from Bleeding Organ failure Infection Other ……………………………………….
Complication None Infection-associated hemophagocytic syndrome Encephalitis/Meningitis Renal failure Liver failure Rhabdomyolysis Other infection
Statistical analysis Descriptive statistics will be used to characterize the study population, and statistical tests (e.g., the chi-square test, t-tests, logistic regression) will be employed to analyze and comparison severity of bleeding and outcomes among types of bleeding disorders
- Keywords
- Dengue, Congenital bleeding disorders, Replacement
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dengue infection in patients with congenital bleeding disorders | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)
Mortality
Percentage of mortality
Measured: 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
Compared percentage of severity of bleeding between hemophilia and other bleeding disorders
Measured: 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
Compared percentage of mortality outcome between hemophilia and other bleeding disorders
Measured: Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Dec 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Dengue DiseaseStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nongnuch Sirachainan, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409857
- Sponsor's protocol ID
- 7249
- Other IDs
- MURA2025/385
- Acronym
- DengueCBDR
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
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.
PubMed 11791984Wijayaratne 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.
PubMed 25889043Chuansumrit 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.
PubMed 21070495Sosothikul D, Thisyakorn U, Thisyakorn C. HEMOSTATIC STUDIES IN DENGUE PATIENTS. Southeast Asian J Trop Med Public Health. 2015;46 Suppl 1:43-5.
PubMed 26506731Sosothikul 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.
PubMed 17393026Chuansumrit 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.
PubMed 24120237Chuansumrit 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.
PubMed 23082583Gubler DJ. Dengue and dengue hemorrhagic fever. Clin Microbiol Rev. 1998 Jul;11(3):480-96. doi: 10.1128/CMR.11.3.480.
PubMed 9665979Simmons 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.
PubMed 22494122Kalayanarooj 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.
PubMed 22500140
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Registry of Dengue Infection in Congenital Bleeding Disorders (DengueCBDR)
- ClinicalTrials.gov ID
- NCT07409857
- Acronym / sponsor ID
- DengueCBDR / 7249
- Keywords
- Dengue, Congenital bleeding disorders, Replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
The global incidence of dengue has markedly increased over the past two decades, posing a substantial public health challenge. From 2000 to 2019, the World Health Organization (WHO) documented a tenfold surge in reported cases worldwide, increasing from 500,000 to 5.2 million, with reported instances spreading across 129 countries.
Dengue fever, a viral infection transmitted by Aedes mosquitoes, is a major health issue in tropical and subtropical regions. Dengue virus (DENV) causes systemic infection in 25% of infected individuals. The symptoms include fever, rash, and, in severe cases, hemorrhagic manifestations. Around 20-30% of symptomatic patients developed Dengue Hemorrhagic Fever (DHF), which leads to increased vascular permeability, thrombocytopenia, and coagulopathy, which are known to increase the risk of bleeding. The most serious presentation is Dengue Shock Syndrome (DSS), which can cause substantial morbidity and mortality, particularly in vulnerable populations. One such vulnerable group is individuals with congenital bleeding disorders (CBDS), such as hemophilia, von Willebrand disease (vWD), platelet disorders, and other coagulation factor deficiencies.
Individuals with CBD have an inherent predisposition to bleeding complications, which could be exacerbated by the platelet dysfunction and vascular leakage associated with dengue infection. In addition, the interaction between the pathophysiology of dengue and bleeding disorders creates significant challenges in the diagnosis, management, and treatment of these individuals. Despite the importance of this issue, there is a lack of comprehensive registries or data-collection systems that track the incidence and outcomes of dengue infection among individuals with congenital bleeding disorders.
Dengue infection in patients with hemophilia was reported. A total of six patients in a cohort of 843 patients had underlying hemophilia; five with hemophilia A and one with hemophilia B. Replacement therapy was higher in patients with bleeding disorders with dengue, compared to other febrile illnesses. All of them had bleeding during dengue infection. The mortality rate was 16%. In addition, severe hemophilia patients presented with bleeding during the febrile stage while the platelet count was normal, then required factor replacement therapy. However, there is limited data on bleeding severity, replacement or prophylaxis protocols, and outcomes for this population.
This research aims to establish a registry of dengue infections among individuals with CBDs to understand bleeding complications, management, and outcomes of these patients. The registry will gather data on the clinical course, complications, management strategies, and outcomes of dengue infection in this population.
Primary Objective:
- To develop a registry of dengue infections in individuals with CBDs.
- To evaluate the bleeding complications, replacement therapy and outcomes of dengue infections in individuals with CBDs.
Secondary Objectives (if any):
To compare bleeding severity and outcome among types of bleeding disorders
Study design/methodology:
An international multicenter, retrospective, from 1 January 2015 to 31 December 2025, and prospective cohort study, involving hospitals that treat individuals with CBDs with dengue infection. The registry format will be provided using a REDCap system
Study Population:
Inclusion Criteria
Patients, aged ≥ 1 day old, diagnosed with CBDs (e.g., hemophilia, Von Willebrand disease, and other coagulation factor deficiency) who are diagnosed dengue infection, based on WHO criteria
Exclusion Criteria
Patients with CBDs with dengue infection who are not willing to participate the study
Registration information (include in the document link)
PART A: General information
Age at diagnosis.......year.........month
Sex
Underlying inherited bleeding disorder: Hemophilia, Coagulation factor deficiency, Platelet disorders, von Willebrand disease Prophylaxis: Factor dose and frequency
PART B: Dengue infection
Diagnosis: Clinical, probable, definite, uncertain (criteria is defined) Onset of presentation Fever Bleeding symptoms Replacement therapy during dengue infection Febrile stage Toxic (leakage, shock) stage Recovery
Outcome Survive Improved without sequelae Improved with sequelae Death from Bleeding Organ failure Infection Other ……………………………………….
Complication None Infection-associated hemophagocytic syndrome Encephalitis/Meningitis Renal failure Liver failure Rhabdomyolysis Other infection
Statistical analysis Descriptive statistics will be used to characterize the study population, and statistical tests (e.g., the chi-square test, t-tests, logistic regression) will be employed to analyze and comparison severity of bleeding and outcomes among types of bleeding disorders
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 14 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dengue infection in patients with congenital bleeding disorders | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with congenital bleeding disorders of any age who have dengue infection
Key inclusion criteria (21 listed)
- 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;
- 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)
- Positive dengue IgM
- 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 infection with signs of bleeding (including positive tourniquet test) with platelet count < 100,000/uL and with signs of leakage (one of the following):
Key exclusion criteria (1 listed)
- Patients with CBDs with dengue infection who are not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severity of Bleeding
Time frame: Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)
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
Amount of replacement therapy
Time frame: Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)
Percentage of patients receiving blood product, Percent of factor activity requirement during dengue infection
Mortality
Time frame: Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)
Percentage of mortality
2 secondary outcomes
Severity of bleeding among congenital bleeding disorders
Time frame: 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
Time frame: Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background1. 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: PubMed 11791984Krishnamurti 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.
- Background: PubMed 25889043Wijayaratne 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.
- Background: PubMed 21070495Chuansumrit 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.
- Background: PubMed 26506731Sosothikul D, Thisyakorn U, Thisyakorn C. HEMOSTATIC STUDIES IN DENGUE PATIENTS. Southeast Asian J Trop Med Public Health. 2015;46 Suppl 1:43-5.
- Background: PubMed 17393026Sosothikul 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.
- Background: PubMed 24120237Chuansumrit 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.
- Background: PubMed 23082583Chuansumrit 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.
- Background: PubMed 9665979Gubler DJ. Dengue and dengue hemorrhagic fever. Clin Microbiol Rev. 1998 Jul;11(3):480-96. doi: 10.1128/CMR.11.3.480.
- Background: PubMed 22494122Simmons 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.
- Background: PubMed 22500140Kalayanarooj 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.
- Proposal, Data information, Ethic approvalLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue Disease and Dengue Haemorrhagic Fever, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nongnuch Sirachainan, MD (+66865603103, nongnuch.sir@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Bleeding (time frame: Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07409857, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.