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Adult Dengue Platelet Study (ADEPT)

Primary Purpose

Dengue Fever

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Platelet transfusion
Supportive care
Sponsored by
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dengue Fever focused on measuring Dengue, Platelet transfusion, Bleeding, Prevention

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Platelet transfusion

Supportive care

Arm Description

4 units of platelets for patients with platelet count <20x10^3/uL

No platelet transfusion for patients with platelet count <20x10^3/uL

Outcomes

Primary Outcome Measures

Clinical bleeding excluding petechiae with a subgroup analysis for severe clinical bleeding.

Secondary Outcome Measures

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

Full Information

First Posted
November 3, 2009
Last Updated
August 23, 2015
Sponsor
Tan Tock Seng Hospital
Collaborators
Singapore General Hospital, Changi General Hospital, National University Hospital, Singapore, University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT01030211
Brief Title
Adult Dengue Platelet Study
Acronym
ADEPT
Official Title
Adult Dengue Platelet Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tan Tock Seng Hospital
Collaborators
Singapore General Hospital, Changi General Hospital, National University Hospital, Singapore, University of Malaya

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Prophylactic platelet transfusion is safe in hospitalised dengue patients with severe thrombocytopenia. Prophylactic platelet transfusion is effective in preventing bleeding in hospitalised dengue patients with severe thrombocytopenia.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue Fever
Keywords
Dengue, Platelet transfusion, Bleeding, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
372 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet transfusion
Arm Type
Active Comparator
Arm Description
4 units of platelets for patients with platelet count <20x10^3/uL
Arm Title
Supportive care
Arm Type
Other
Arm Description
No platelet transfusion for patients with platelet count <20x10^3/uL
Intervention Type
Procedure
Intervention Name(s)
Platelet transfusion
Intervention Description
4 units of platelets for patients with platelet count <20x10^3/uL
Intervention Type
Other
Intervention Name(s)
Supportive care
Intervention Description
Supportive care includes symptomatic treatment, fluid therapy and monitoring of full blood count and blood pressure
Primary Outcome Measure Information:
Title
Clinical bleeding excluding petechiae with a subgroup analysis for severe clinical bleeding.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Platelet increment post-transfusion
Time Frame
5 years
Title
Time to platelet > 50 x 10^3/uL
Time Frame
5 years
Title
Changes in cytokines
Time Frame
5 years
Title
Length of stay
Time Frame
5 years
Title
Plasma leakage
Time Frame
5 years
Title
DHF/DSS
Time Frame
5 years
Title
ICU admission
Time Frame
5 years
Title
Death
Time Frame
5 years
Title
Secondary bacterial infection
Time Frame
5 years
Title
Adverse events from transfusion
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 21years 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 Platelets ≤ 20x103/μL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yee S Leo, FRCP
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Facility Name
Tan Tock Seng Hospital, National University Health System, Singapore General Hospital, Changi General Hospital
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
31626692
Citation
Archuleta S, Chia PY, Wei Y, Syed-Omar SF, Low JG, Oh HM, Fisher D, Ponnampalavanar SSL, Wijaya L, Kamarulzaman A, Lum LCS, Tambyah PA, Leo YS, Lye DC. Predictors and Clinical Outcomes of Poor Platelet Recovery in Adult Dengue With Thrombocytopenia: A Multicenter, Prospective Study. Clin Infect Dis. 2020 Jul 11;71(2):383-389. doi: 10.1093/cid/ciz850.
Results Reference
derived
PubMed Identifier
28283286
Citation
Lye DC, Archuleta S, Syed-Omar SF, Low JG, Oh HM, Wei Y, Fisher D, Ponnampalavanar SSL, Wijaya L, Lee LK, Ooi EE, Kamarulzaman A, Lum LC, Tambyah PA, Leo YS. Prophylactic platelet transfusion plus supportive care versus supportive care alone in adults with dengue and thrombocytopenia: a multicentre, open-label, randomised, superiority trial. Lancet. 2017 Apr 22;389(10079):1611-1618. doi: 10.1016/S0140-6736(17)30269-6. Epub 2017 Mar 8.
Results Reference
derived
PubMed Identifier
25299251
Citation
Tomashek KM, Biggerstaff BJ, Ramos MM, Perez-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.
Results Reference
derived

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Adult Dengue Platelet Study

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