Adult Dengue Platelet Study
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.
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 Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Dengue Fever
Intervention
Platelet transfusion, Supportive care
Location
Tan Tock Seng Hospital, National University Health System, Singapore General Hospital, Changi General Hospital
Singapore
Singapore
Status
Not yet recruiting
Source
Tan Tock Seng Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01030211
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Dengue
An acute infectious, eruptive, febrile disease caused by four antigenically related but distinct serotypes of the DENGUE VIRUS. It is transmitted by the bite of infected Aedes mosquitoes, especially A. aegypti. Classical dengue (dengue fever) is self-limiting and characterized by fever, myalgia, headache, and rash. DENGUE HEMORRHAGIC FEVER is a more virulent form of dengue virus infection and a separate clinical entity. (From Dorland, 28th ed)
Dengue Hemorrhagic Fever
A distinct and virulent form of DENGUE characterized by thrombocytopenia and hemoconcentration (grades I and II) and distinguished by a positive tourniquet test. When accompanied by circulatory failure and shock (grades III and IV), it is called dengue shock syndrome. (From Dorland, 28th ed)
Antigens, Human Platelet
Human alloantigens expressed only on platelets, specifically on platelet membrane glycoproteins. These platelet-specific antigens are immunogenic and can result in pathological reactions to transfusion therapy.
Chikungunya Virus
A species of ALPHAVIRUS causing an acute dengue-like fever.
Dengue Virus
A species of the genus FLAVIVIRUS which causes an acute febrile and sometimes hemorrhagic disease in man. Dengue is mosquito-borne and four serotypes are known.
Clinical Trials
Dengue fever, which is caused by dengue viruses, is a major health problem in subtropical regions of the world. There are four different forms (serotypes) of dengue virus that can cause d...
Diagnosis and Characterization of Dengue Fever in Children
Dengue virus is an arbovirus transmitted by mosquitoes which causes significant morbidity and mortality among children in tropical regions, especially in resource limited countries. The ob...
A Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups
The purpose of this study is to show that a therapeutic platelet transfusion strategy (i.e. platelet transfusion only in case of bleeding) needs minimally a quarter less of transfusions co...
Originally test host's to understand the tracking healthily and immune change of the dengue fever in Taiwan. Blood drawing 20 c.c for liver examination, kidney and other biochemical functi...
Safety and Immune Response to Two Doses of rDEN2/4delta30 Dengue Vaccine
Dengue fever, caused by dengue viruses, is a major health problem in the tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune respon...
PubMed Articles
The authors report the difficulties faced in diagnosing and managing dengue fever in a 16-year-old boy suffering from glucose-6-phosphodehydrogenase deficiency and thalassemia intermedia 2 months aft...
Dengue Fever in South Korea, 2006-2010.
TO THE EDITOR: Dengue fever is an acute, febrile disease caused by a flavivirus and is transmitted by Aedes spp. mosquitoes (1). South Korea is not considered as a region to which dengue virus is ende...
Dengue hemorrhagic fever and shock syndromes.
OBJECTIVES:: To provide a comprehensive review of dengue, with an emphasis on clinical syndromes, classification, diagnosis, and management, and to outline relevant aspects of epidemiology, immunopath...
Maternal and perinatal outcomes of dengue in PortSudan, Eastern Sudan.
ABSTRACT: Aim: To investigate maternal and perinatal outcomes (maternal death, preterm delivery, low birth weight and perinatal mortality) of dengue at PortSudan and Elmawani hospitals in the eastern...
Femoral compressive neuropathy from iliopsoas haematoma complicating dengue hemorrhagic fever.
Dengue fever is a debilitating mosquito-borne disease caused by dengue virus. We reported a case of femoral compression neuropathy due to iliopsoas hematoma complicating dengue hemorrhagic fever. Ilio...
