Adult Dengue Platelet Study
- Conditions
- Dengue Fever
- Interventions
- Procedure: Platelet transfusionOther: Supportive care
- Registration Number
- NCT01030211
- Lead Sponsor
- Tan Tock Seng Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 372
-
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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Platelet transfusion Platelet transfusion 4 units of platelets for patients with platelet count \<20x10\^3/uL Supportive care Supportive care No platelet transfusion for patients with platelet count \<20x10\^3/uL
- Primary Outcome Measures
Name Time Method Clinical bleeding excluding petechiae with a subgroup analysis for severe clinical bleeding. 5 years
- Secondary Outcome Measures
Name Time Method Changes in cytokines 5 years Secondary bacterial infection 5 years Length of stay 5 years DHF/DSS 5 years Time to platelet > 50 x 10^3/uL 5 years Plasma leakage 5 years Adverse events from transfusion 5 years Platelet increment post-transfusion 5 years Death 5 years ICU admission 5 years
Trial Locations
- Locations (2)
Tan Tock Seng Hospital, National University Health System, Singapore General Hospital, Changi General Hospital
🇸🇬Singapore, Singapore
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia