Adult Dengue Platelet Study (ADEPT)

August 23, 2015 updated by: David Lye, Tan Tock Seng Hospital

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

372

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kuala Lumpur, Malaysia
        • University Malaya Medical Centre
      • Singapore, Singapore
        • Tan Tock Seng Hospital, National University Health System, Singapore General Hospital, Changi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Platelet transfusion
4 units of platelets for patients with platelet count <20x10^3/uL
4 units of platelets for patients with platelet count <20x10^3/uL
Other: Supportive care
No platelet transfusion for patients with platelet count <20x10^3/uL
Supportive care includes symptomatic treatment, fluid therapy and monitoring of full blood count and blood pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical bleeding excluding petechiae with a subgroup analysis for severe clinical bleeding.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Platelet increment post-transfusion
Time Frame: 5 years
5 years
Time to platelet > 50 x 10^3/uL
Time Frame: 5 years
5 years
Changes in cytokines
Time Frame: 5 years
5 years
Length of stay
Time Frame: 5 years
5 years
Plasma leakage
Time Frame: 5 years
5 years
DHF/DSS
Time Frame: 5 years
5 years
ICU admission
Time Frame: 5 years
5 years
Death
Time Frame: 5 years
5 years
Secondary bacterial infection
Time Frame: 5 years
5 years
Adverse events from transfusion
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 3, 2009

First Submitted That Met QC Criteria

December 9, 2009

First Posted (Estimate)

December 11, 2009

Study Record Updates

Last Update Posted (Estimate)

August 25, 2015

Last Update Submitted That Met QC Criteria

August 23, 2015

Last Verified

August 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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