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Adult Dengue Platelet Study (ADEPT)

This study has been completed.
Singapore General Hospital
Changi General Hospital
National University Hospital, Singapore
University of Malaya
Information provided by (Responsible Party):
David Lye, Tan Tock Seng Hospital Identifier:
First received: November 3, 2009
Last updated: August 23, 2015
Last verified: August 2015

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.

Condition Intervention
Dengue Fever
Procedure: Platelet transfusion
Other: Supportive care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Adult Dengue Platelet Study

Resource links provided by NLM:

Further study details as provided by Tan Tock Seng Hospital:

Primary Outcome Measures:
  • Clinical bleeding excluding petechiae with a subgroup analysis for severe clinical bleeding. [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 372
Study Start Date: January 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Platelet transfusion
4 units of platelets for patients with platelet count <20x10^3/uL
Procedure: Platelet transfusion
4 units of platelets for patients with platelet count <20x10^3/uL
Supportive care
No platelet transfusion 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

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.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥ 21years
  2. 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
  3. Platelets ≤ 20x103/μL
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Please refer to this study by its identifier: NCT01030211

University Malaya Medical Centre
Kuala Lumpur, Malaysia
Tan Tock Seng Hospital, National University Health System, Singapore General Hospital, Changi General Hospital
Singapore, Singapore
Sponsors and Collaborators
Tan Tock Seng Hospital
Singapore General Hospital
Changi General Hospital
National University Hospital, Singapore
University of Malaya
Principal Investigator: Yee S Leo, FRCP Tan Tock Seng Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: David Lye, Dr David Lye, Tan Tock Seng Hospital Identifier: NCT01030211     History of Changes
Other Study ID Numbers: TTSH ADEPT
Study First Received: November 3, 2009
Last Updated: August 23, 2015

Keywords provided by Tan Tock Seng Hospital:
Platelet transfusion

Additional relevant MeSH terms:
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral processed this record on May 24, 2017