Adult Dengue Platelet Study

Adult Dengue Platelet Study

Sponsors

Lead sponsor: Tan Tock Seng Hospital

Collaborator: Singapore General Hospital
Changi General Hospital
National University Hospital, Singapore
University of Malaya

Source 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.

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.

Overall Status Completed
Start Date January 2010
Completion Date December 2014
Primary Completion Date December 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Clinical bleeding excluding petechiae with a subgroup analysis for severe clinical bleeding. 5 years
Secondary Outcome
Measure Time Frame
Platelet increment post-transfusion 5 years
Time to platelet > 50 x 10^3/uL 5 years
Changes in cytokines 5 years
Length of stay 5 years
Plasma leakage 5 years
DHF/DSS 5 years
ICU admission 5 years
Death 5 years
Secondary bacterial infection 5 years
Adverse events from transfusion 5 years
Enrollment 372
Condition
Intervention

Intervention type: Procedure

Intervention name: Platelet transfusion

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

Arm group label: Platelet transfusion

Intervention type: Other

Intervention name: Supportive care

Description: Supportive care includes symptomatic treatment, fluid therapy and monitoring of full blood count and blood pressure

Arm group label: Supportive care

Eligibility

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

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Yee S Leo, FRCP Principal Investigator Tan Tock Seng Hospital
Location
facility
University Malaya Medical Centre | Kuala Lumpur, Malaysia
Tan Tock Seng Hospital, National University Health System, Singapore General Hospital, Changi General Hospital | Singapore, Singapore
Location Countries

Malaysia

Singapore

Verification Date

August 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Tan Tock Seng Hospital

Investigator full name: David Lye

Investigator title: Dr David Lye

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Platelet transfusion

Arm group type: Active Comparator

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

Arm group label: Supportive care

Arm group type: Other

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

Acronym ADEPT
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov