- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01030211
Adult Dengue Platelet Study (ADEPT)
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:
- Prophylactic platelet transfusion is safe in hospitalised dengue patients with severe thrombocytopenia.
- Prophylactic platelet transfusion is effective in preventing bleeding in hospitalised dengue patients with severe thrombocytopenia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients fulfilling inclusion and exclusion criteria, and giving informed consent, will be randomised to a treatment arm of 4 units of platelets for every day they have a platelet count <20x10^3/uL, or a control arm with supportive care. Patients will be followed up daily till hospital discharge, and again at day 21.
It is assumed that the incidence of bleeding from randomization to Day 7 or discharge, whichever earlier, is 10% for the control (no transfusion) group and 5% for the intervention (transfusion) group. With 1:1 allocation ratio, to attain 80% power and one-sided 5% type I error rate, the required number of subjects in each arm is 382 by a Chi-square test with Yates' continuity correction. If a drop-out rate of 5% is allowed, the required number increases to approximately 400 per arm.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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,
- leucopoenia,
- one or more warning sign
- abdominal pain/tenderness,
- persistent vomiting,
- clinical fluid accumulation,
- mucosal bleed,
- lethargy/restlessness,
- liver enlargement >2cm,
- increase in haematocrit concurrent with rapid decrease in platelet count
- Platelets ≤ 20x103/μL
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Platelet transfusion
4 units of platelets for patients with platelet count <20x10^3/uL
|
4 units of platelets for patients with platelet count <20x10^3/uL
|
Other: Supportive care
No platelet transfusion for patients with platelet count <20x10^3/uL
|
Supportive care includes symptomatic treatment, fluid therapy and monitoring of full blood count and blood pressure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical bleeding excluding petechiae with a subgroup analysis for severe clinical bleeding.
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Platelet increment post-transfusion
Time Frame: 5 years
|
5 years
|
Time to platelet > 50 x 10^3/uL
Time Frame: 5 years
|
5 years
|
Changes in cytokines
Time Frame: 5 years
|
5 years
|
Length of stay
Time Frame: 5 years
|
5 years
|
Plasma leakage
Time Frame: 5 years
|
5 years
|
DHF/DSS
Time Frame: 5 years
|
5 years
|
ICU admission
Time Frame: 5 years
|
5 years
|
Death
Time Frame: 5 years
|
5 years
|
Secondary bacterial infection
Time Frame: 5 years
|
5 years
|
Adverse events from transfusion
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yee S Leo, FRCP, Tan Tock Seng Hospital
Publications and helpful links
General Publications
- 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.
- Lye 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.
- Tomashek 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TTSH ADEPT
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