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Dengue FeverADEPTNCT01030211

Adult Dengue Platelet Study

A study testing Platelet transfusion and Supportive care in people with Dengue Fever, run by Tan Tock Seng Hospital at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Dengue Fever
What is being tested?
Platelet transfusion and Supportive care
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
372 participants
Where
2 sitesin 2 countries
Study dates
Jan 2010to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 21years
  • Probable or confirmed dengue
  • 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.
  • 1997 criteria: Acute febrile illness and two or more of the following:
  • headache,
  • retro-orbital pain,
Show all 25Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Malaysia1 site

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur

Other trials in Malaysia

Singapore1 site

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

    Singapore, Singapore

Other trials in Singapore

About this study

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.
Read the 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.

Conditions
Dengue Fever
Being tested
Platelet transfusion, Supportive care
Keywords
Dengue, Platelet transfusion, Bleeding, Prevention
Medical subject headings
Dengue, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Platelet transfusionProcedure or surgery

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

  • Supportive careOther

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

Study groups in NCT01030211
Study groupRoleWhat they receive
Platelet transfusionActive comparator4 units of platelets for patients with platelet count <20x10^3/uL
Receives: Procedure: Platelet transfusion
Supportive careOtherNo platelet transfusion for patients with platelet count <20x10^3/uL
Receives: Other: Supportive care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 5 years

Secondary outcomes (10)

  1. Platelet increment post-transfusion

    Measured: 5 years

  2. Time to platelet > 50 x 10^3/uL

    Measured: 5 years

  3. Changes in cytokines

    Measured: 5 years

  4. Length of stay

    Measured: 5 years

  5. Plasma leakage

    Measured: 5 years

  6. DHF/DSS

    Measured: 5 years

  7. ICU admission

    Measured: 5 years

  8. Death

    Measured: 5 years

  9. Secondary bacterial infection

    Measured: 5 years

  10. Adverse events from transfusion

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01030211
Sponsor's protocol ID
TTSH ADEPT
Acronym
ADEPT
Status last verified
Aug 2015
First submitted
3 Nov 2009
Last updated
25 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31626692

  • 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.

    PubMed 28283286

  • 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.

    PubMed 25299251

Questions about this trial

What is this clinical trial studying?

A study testing Platelet transfusion and Supportive care in people with Dengue Fever, run by Tan Tock Seng Hospital at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Malaysia, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical bleeding excluding petechiae with a subgroup analysis for severe clinical bleeding. (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01030211, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2015.

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