Dengue Fever Clinical Trial
Official title:
Adult Dengue Platelet Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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