NCT01030211

Adult Dengue Platelet Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 372 (actual)
• Sponsor: Tan Tock Seng Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dengue Fever

Interventions

Type	Name	Description
PROCEDURE	Platelet transfusion	4 units of platelets for patients with platelet count \<20x10\^3/uL
OTHER	Supportive care	Supportive care includes symptomatic treatment, fluid therapy and monitoring of full blood count and blood pressure

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2009-12-11
• Last updated: 2015-08-25

Locations

2 sites across 2 countries: Malaysia, Singapore