Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-04 @ 7:47 AM
Study NCT ID:
NCT07409857
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
International Registry of Dengue Infection in Congenital Bleeding Disorders (DengueCBDR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003715', 'term': 'Dengue'}], 'ancestors': [{'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '14 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-01-20', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of Bleeding', 'timeFrame': 'Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)', 'description': 'Percentage of major and clinically relevant non-major bleeding (CRNMB)\n\nMajor 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\n\nClinically 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'}, {'measure': 'Amount of replacement therapy', 'timeFrame': 'Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)', 'description': 'Percentage of patients receiving blood product, Percent of factor activity requirement during dengue infection'}, {'measure': 'Mortality', 'timeFrame': 'Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)', 'description': 'Percentage of mortality'}], 'secondaryOutcomes': [{'measure': 'Severity of bleeding among congenital bleeding disorders', 'timeFrame': 'Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)', 'description': 'Compared percentage of severity of bleeding between hemophilia and other bleeding disorders'}, {'measure': 'Mortality among congenital bleeding disorders', 'timeFrame': 'Day of fever (Day 1) to Day 14 or Day of discharge from the hospital (if less than day 14)', 'description': 'Compared percentage of mortality outcome between hemophilia and other bleeding disorders'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dengue', 'Congenital bleeding disorders', 'Replacement'], 'conditions': ['Dengue Disease', 'Dengue Haemorrhagic Fever', 'Dengue Fever', 'Dengue Fever With Warning Signs']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '11791984', 'type': 'BACKGROUND', 'citation': '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': '25889043', 'type': 'BACKGROUND', 'citation': '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': '21070495', 'type': 'BACKGROUND', 'citation': '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': '26506731', 'type': 'BACKGROUND', 'citation': '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': '17393026', 'type': 'BACKGROUND', 'citation': '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': '24120237', 'type': 'BACKGROUND', 'citation': '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': '23082583', 'type': 'BACKGROUND', 'citation': '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': '9665979', 'type': 'BACKGROUND', 'citation': 'Gubler DJ. Dengue and dengue hemorrhagic fever. Clin Microbiol Rev. 1998 Jul;11(3):480-96. doi: 10.1128/CMR.11.3.480.'}, {'pmid': '22494122', 'type': 'BACKGROUND', 'citation': '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': '22500140', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://drive.google.com/drive/folders/1kfl4mgYC7vYNrq8qz2qEB146QLzdwkpo?usp=sharing', 'label': 'Proposal, Data information, Ethic approval'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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%.\n\nDespite 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.\n\nThe 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.', 'detailedDescription': 'Background:\n\nThe 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.\n\nDengue 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.\n\nIndividuals 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.\n\nDengue 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.\n\nThis 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.\n\nPrimary Objective:\n\n1. To develop a registry of dengue infections in individuals with CBDs.\n2. To evaluate the bleeding complications, replacement therapy and outcomes of dengue infections in individuals with CBDs.\n\nSecondary Objectives (if any):\n\nTo compare bleeding severity and outcome among types of bleeding disorders\n\nStudy design/methodology:\n\nAn 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\n\nStudy Population:\n\nInclusion Criteria\n\nPatients, 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\n\nExclusion Criteria\n\nPatients with CBDs with dengue infection who are not willing to participate the study\n\nRegistration information (include in the document link)\n\nPART A: General information\n\nAge at diagnosis.......year.........month\n\nSex\n\nUnderlying inherited bleeding disorder: Hemophilia, Coagulation factor deficiency, Platelet disorders, von Willebrand disease Prophylaxis: Factor dose and frequency\n\nPART B: Dengue infection\n\nDiagnosis: 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\n\nOutcome Survive Improved without sequelae Improved with sequelae Death from Bleeding Organ failure Infection Other ……………………………………….\n\nComplication None Infection-associated hemophagocytic syndrome Encephalitis/Meningitis Renal failure Liver failure Rhabdomyolysis Other infection\n\nStatistical 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with congenital bleeding disorders of any age who have dengue infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients, 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;\n\nClinical dengue infection:\n\nSymptoms 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)\n\nProbable dengue infection:\n\nPositive dengue IgM\n\nDefinite dengue infection:\n\nSeroconversion 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\n\nDengue hemorrhagic fever:\n\nDengue infection with signs of bleeding (including positive tourniquet test) with platelet count \\< 100,000/uL and with signs of leakage (one of the following):\n\n1. Increase Hct at least 15-20% from baseline\n2. Serum albumin \\< 35 g/L\n3. Presence of pleural effusion or ascites\n\nDengue shock syndrome:\n\n1. Narrow pulse pressure (\\< 20 mmHg)\n2. Hypotension\n3. Signs of poor tissue perfusion\n\nSeverity of DHF:\n\n* Grade I: Positive tourniquet test\n* Grade II: Spontaneous bleeding\n* Grade III: Circulatory failure (narrow pulse pressure ≤20 mmHg, hypotension, or signs of poor tissue perfusion)\n* Grade IV: Profound shock with undetectable blood pressure\n\nExclusion Criteria:\n\n* Patients with CBDs with dengue infection who are not willing to participate in the study'}, 'identificationModule': {'nctId': 'NCT07409857', 'acronym': 'DengueCBDR', 'briefTitle': 'International Registry of Dengue Infection in Congenital Bleeding Disorders (DengueCBDR)', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'International Registry of Dengue Infection in Congenital Bleeding Disorders (DengueCBDR)', 'orgStudyIdInfo': {'id': '7249'}, 'secondaryIdInfos': [{'id': 'MURA2025/385', 'type': 'OTHER', 'domain': 'Faculty of Medicine Ramathibodi Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dengue infection in patients with congenital bleeding disorders'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Nongnuch Sirachainan, MD', 'role': 'CONTACT', 'email': 'nongnuch.sir@mahidol.ac.th', 'phone': '+66865603103'}], 'facility': 'Ramathibodi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Nongnuch Sirachainan, MD', 'role': 'CONTACT', 'email': 'nongnuch.sir@mahidol.ac.th', 'phone': '+66865603103'}, {'name': 'Sawitree Chawwapee', 'role': 'CONTACT', 'email': 'imdrunkcat@hotmail.com', 'phone': '+6622011749'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nongnuch Sirachainan', 'investigatorAffiliation': 'Mahidol University'}}}}