Adult Dengue Platelet Study
ADEPT
1 other identifier
interventional
372
2 countries
2
Brief Summary
Retrospective data in children with dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS), and in adults with dengue fever (DF), suggested a lack of benefit from prophylactic platelet transfusion for severe thrombocytopenia in dengue patients without bleeding. However, in Taiwan and Singapore, platelet transfusion was given to 13-50% of hospitalised dengue patients. This is a prospective randomised study to examine the safety and efficacy of prophylactic platelet transfusion in adults with dengue and severe thrombocytopenia without bleeding. The hypotheses are:
- 1.Prophylactic platelet transfusion is safe in hospitalised dengue patients with severe thrombocytopenia.
- 2.Prophylactic platelet transfusion is effective in preventing bleeding in hospitalised dengue patients with severe thrombocytopenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2009
CompletedFirst Posted
Study publicly available on registry
December 11, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 25, 2015
August 1, 2015
4.9 years
November 3, 2009
August 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical bleeding excluding petechiae with a subgroup analysis for severe clinical bleeding.
5 years
Secondary Outcomes (10)
Platelet increment post-transfusion
5 years
Time to platelet > 50 x 10^3/uL
5 years
Changes in cytokines
5 years
Length of stay
5 years
Plasma leakage
5 years
- +5 more secondary outcomes
Study Arms (2)
Platelet transfusion
ACTIVE COMPARATOR4 units of platelets for patients with platelet count \<20x10\^3/uL
Supportive care
OTHERNo platelet transfusion for patients with platelet count \<20x10\^3/uL
Interventions
4 units of platelets for patients with platelet count \<20x10\^3/uL
Supportive care includes symptomatic treatment, fluid therapy and monitoring of full blood count and blood pressure
Eligibility Criteria
You may qualify if:
- Age ≥ 21years
- Probable or confirmed dengue
- a) Confirmed dengue: laboratory confirmation of acute dengue by either i) positive polymerase chain reaction (PCR) for viral ribonucleic acid (RNA), or ii)positive NS1 antigen test with a compatible clinical syndrome b) Probable dengue: Positive acute dengue serology and clinical presentation fulfilling either WHO 1997 or 2009 criteria for probable dengue.
- i) 1997 criteria: Acute febrile illness and two or more of the following:
- headache,
- retro-orbital pain,
- myalgia,
- arthralgia,
- rash,
- hemorrhagic manifestations,
- leucopoenia ii) 2009 criteria: Fever and two of the following:
- nausea/vomiting,
- rash,
- aches/pains,
- positive tourniquet test,
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tan Tock Seng Hospitallead
- Singapore General Hospitalcollaborator
- Changi General Hospitalcollaborator
- National University Hospital, Singaporecollaborator
- University of Malayacollaborator
Study Sites (2)
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Tan Tock Seng Hospital, National University Health System, Singapore General Hospital, Changi General Hospital
Singapore, Singapore, Singapore
Related Publications (3)
Archuleta S, Chia PY, Wei Y, Syed-Omar SF, Low JG, Oh HM, Fisher D, Ponnampalavanar SSL, Wijaya L, Kamarulzaman A, Lum LCS, Tambyah PA, Leo YS, Lye DC. Predictors and Clinical Outcomes of Poor Platelet Recovery in Adult Dengue With Thrombocytopenia: A Multicenter, Prospective Study. Clin Infect Dis. 2020 Jul 11;71(2):383-389. doi: 10.1093/cid/ciz850.
PMID: 31626692DERIVEDLye DC, Archuleta S, Syed-Omar SF, Low JG, Oh HM, Wei Y, Fisher D, Ponnampalavanar SSL, Wijaya L, Lee LK, Ooi EE, Kamarulzaman A, Lum LC, Tambyah PA, Leo YS. Prophylactic platelet transfusion plus supportive care versus supportive care alone in adults with dengue and thrombocytopenia: a multicentre, open-label, randomised, superiority trial. Lancet. 2017 Apr 22;389(10079):1611-1618. doi: 10.1016/S0140-6736(17)30269-6. Epub 2017 Mar 8.
PMID: 28283286DERIVEDTomashek KM, Biggerstaff BJ, Ramos MM, Perez-Guerra CL, Garcia Rivera EJ, Sun W. Physician survey to determine how dengue is diagnosed, treated and reported in puerto rico. PLoS Negl Trop Dis. 2014 Oct 9;8(10):e3192. doi: 10.1371/journal.pntd.0003192. eCollection 2014 Oct.
PMID: 25299251DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yee S Leo, FRCP
Tan Tock Seng Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr David Lye
Study Record Dates
First Submitted
November 3, 2009
First Posted
December 11, 2009
Study Start
January 1, 2010
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 25, 2015
Record last verified: 2015-08