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Adult Dengue Platelet Study (ADEPT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01030211
First Posted: December 11, 2009
Last Update Posted: August 25, 2015
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.
Collaborators:
Singapore General Hospital
Changi General Hospital
National University Hospital, Singapore
University of Malaya
Information provided by (Responsible Party):
David Lye, Tan Tock Seng Hospital
November 3, 2009
December 11, 2009
August 25, 2015
January 2010
December 2014   (Final data collection date for primary outcome measure)
Clinical bleeding excluding petechiae with a subgroup analysis for severe clinical bleeding. [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT01030211 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Adult Dengue Platelet Study
Adult Dengue Platelet Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Dengue Fever
  • 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
  • Active Comparator: Platelet transfusion
    4 units of platelets for patients with platelet count <20x10^3/uL
    Intervention: Procedure: Platelet transfusion
  • Supportive care
    No platelet transfusion for patients with platelet count <20x10^3/uL
    Intervention: Other: Supportive care
Tomashek KM, Biggerstaff BJ, Ramos MM, Pérez-Guerra CL, Garcia Rivera EJ, Sun W. Physician survey to determine how dengue is diagnosed, treated and reported in puerto rico. PLoS Negl Trop Dis. 2014 Oct 9;8(10):e3192. doi: 10.1371/journal.pntd.0003192. eCollection 2014 Oct.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
372
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Malaysia,   Singapore
 
 
NCT01030211
TTSH ADEPT
Yes
Not Provided
Not Provided
David Lye, Tan Tock Seng Hospital
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
Tan Tock Seng Hospital
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP