Adult Dengue Platelet Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dengue Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Platelet transfusion

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

Group Type ACTIVE_COMPARATOR

Platelet transfusion

Intervention Type PROCEDURE

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

Supportive care

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

Group Type OTHER

Supportive care

Intervention Type OTHER

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

Interventions

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Platelet transfusion

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

Intervention Type PROCEDURE

Supportive care

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No