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Adult Dengue Platelet Study (ADEPT)

This study is currently recruiting participants.
Verified July 2011 by Tan Tock Seng Hospital
Sponsor:
Collaborators:
Singapore General Hospital
Changi General Hospital
National University Hospital, Singapore
Information provided by:
Tan Tock Seng Hospital
ClinicalTrials.gov Identifier:
NCT01030211
First received: November 3, 2009
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

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
Procedure: Supportive care

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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 800
Study Start Date: January 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (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
No Intervention: Supportive care
No platelet transfusion for patients with platelet count <20x10^3/uL
 Procedure: 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030211

Contacts
Contact: Yee S Leo, FRCP 6564782874 yee_sin_leo@ttsh.com.sg

Locations
Singapore
Tan Tock Seng Hospital, National University Health System, Singapore General Hospital, Changi General Hospital Recruiting
Singapore, Singapore
Principal Investigator: David C Lye, FRACP            
Principal Investigator: Jenny Low, MRCP            
Principal Investigator: Paul A Tambyah, ABIM            
Principal Investigator: Helen Oh, FRCP            
Sponsors and Collaborators
Tan Tock Seng Hospital
Singapore General Hospital
Changi General Hospital
National University Hospital, Singapore
Investigators
Principal Investigator: Yee S Leo, FRCP Tan Tock Seng Hospital
  More Information

No publications provided

Responsible Party: A/Prof Leo Yee Sin, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT01030211     History of Changes
Other Study ID Numbers: TTSH ADEPT
Study First Received: November 3, 2009
Last Updated: July 20, 2011
Health Authority: Singapore: Clinical Research Unit, Tan Tock Seng Hospital

Keywords provided by Tan Tock Seng Hospital:
Dengue
Platelet transfusion
Bleeding
Prevention

Additional relevant MeSH terms:
Dengue
Dengue Hemorrhagic Fever
Arbovirus Infections
Virus Diseases
 Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral

ClinicalTrials.gov processed this record on May 19, 2013