Adult Dengue Platelet Study

Dengue Fever Clinical Trial

— ADEPT  

Official title:

Adult Dengue Platelet Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030211
• Other study ID #: TTSH ADEPT
• Status: Completed
• Phase: N/A
• First received: November 3, 2009
• Last updated: August 23, 2015
• Start date: January 2010
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Clinical Research Unit, Tan Tock Seng Hospital
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dengue
• Dengue Fever

Intervention

Procedure:
• Platelet transfusion
4 units of platelets for patients with platelet count <20x10^3/uL

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

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Singapore	Tan Tock Seng Hospital, National University Health System, Singapore General Hospital, Changi General Hospital	Singapore

Sponsors (5)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Changi General Hospital, National University Hospital, Singapore, Singapore General Hospital, University of Malaya

Countries where clinical trial is conducted

Malaysia,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical bleeding excluding petechiae with a subgroup analysis for severe clinical bleeding.		5 years	Yes
Secondary	Platelet increment post-transfusion		5 years	Yes
Secondary	Time to platelet > 50 x 10^3/uL		5 years	Yes
Secondary	Changes in cytokines		5 years	Yes
Secondary	Length of stay		5 years	Yes
Secondary	Plasma leakage		5 years	Yes
Secondary	DHF/DSS		5 years	Yes
Secondary	ICU admission		5 years	Yes
Secondary	Death		5 years	Yes
Secondary	Secondary bacterial infection		5 years	Yes
Secondary	Adverse events from transfusion		5 years	Yes