Clinical Trial: Adult Dengue Platelet Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Adult Dengue Platelet Study
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:
- 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.
Detailed Summary:
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.
Sponsor: Tan Tock Seng Hospital
Current Primary Outcome: Clinical bleeding excluding petechiae with a subgroup analysis for severe clinical bleeding. [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Platelet increment post-transfusion [ Time Frame: 5 years ]
- Time to platelet > 50 x 10^3/uL [ Time Frame: 5 years ]
- Changes in cytokines [ Time Frame: 5 years ]
- Length of stay [ Time Frame: 5 years ]
- Plasma leakage [ Time Frame: 5 years ]
- DHF/DSS [ Time Frame: 5 years ]
- ICU admission [ Time Frame: 5 years ]
- Death [ Time Frame: 5 years ]
- Secondary bacterial infection [ Time Frame: 5 years ]
- Adverse events from transfusion [ Time Frame: 5 years ]
Original Secondary Outcome: Same as current
Information By: Tan Tock Seng Hospital
Dates:
Date Received: November 3, 2009
Date Started: January 2010
Date Completion:
Last Updated: August 23, 2015
Last Verified: August 2015
