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Adult Dengue Platelet Study (ADEPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01030211
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : August 25, 2015
Singapore General Hospital
Changi General Hospital
National University Hospital, Singapore
University of Malaya
Information provided by (Responsible Party):
David Lye, Tan Tock Seng Hospital

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:

  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 or disease Intervention/treatment Phase
Dengue Fever Procedure: Platelet transfusion Other: Supportive care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adult Dengue Platelet Study
Study Start Date : January 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Platelet increment post-transfusion [ Time Frame: 5 years ]
  2. Time to platelet > 50 x 10^3/uL [ Time Frame: 5 years ]
  3. Changes in cytokines [ Time Frame: 5 years ]
  4. Length of stay [ Time Frame: 5 years ]
  5. Plasma leakage [ Time Frame: 5 years ]
  6. DHF/DSS [ Time Frame: 5 years ]
  7. ICU admission [ Time Frame: 5 years ]
  8. Death [ Time Frame: 5 years ]
  9. Secondary bacterial infection [ Time Frame: 5 years ]
  10. Adverse events from transfusion [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01030211

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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
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Principal Investigator: Yee S Leo, FRCP Tan Tock Seng Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Lye, Dr David Lye, Tan Tock Seng Hospital Identifier: NCT01030211     History of Changes
Other Study ID Numbers: TTSH ADEPT
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015
Keywords provided by David Lye, Tan Tock Seng Hospital:
Platelet transfusion
Additional relevant MeSH terms:
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Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral