Home » Trials » SLCTR/2007/004


Efficacy of Fresh Frozen Plasma (FFP) on thrombocytopaenia in dengue fever

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SLCTR Registration Number

SLCTR/2007/004


Date of Registration

18 May 2007

The date of last modification

Jan 30, 2019


View original TRDS


Trial Status



Application Summary


Scientific Title of Trial

Efficacy of Fresh Frozen Plasma (FFP) on thrombocytopaenia in dengue fever


Public Title of Trial

Treatment of low platelet count in dengue fever


Disease or Health Condition(s) Studied

Dengue


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

EC/06/007 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)


Trial Details


What is the research question being addressed?

Is FFP effective in treating thrombocytopaenia in dengue?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Study Phase

Not Available


Intervention(s) planned

Intravenous infusion of 600ml of FFP for the treatment group and 600ml of isotonic saline for the controlled group


Inclusion criteria

Clinical and serological evidence of dengue with platelet count below 40,000/c.mm


Exclusion criteria

Platelet count below 10,000/c.mm
seriously ill patients
dengue shock syndrome



Primary outcome(s)

  1. Change in the platelet count after intervention

    []

Secondary outcome(s)

  1. None

    []

Target number/sample size

150 (75 in each group)


Countries of recruitment

Sri Lanka


Anticipated start date

2005-11-01


Anticipated end date

2006-08-31


Date of first enrollment


Date of study completion


Recruitment status

Complete: follow up complete


Funding source

None


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2006-01-12


Approval number

EC/06/007


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo
Institutional Address: No. 25, Kynsey Road, Colombo 00800 Sri Lanka
Telephone: +94-11-2695300 (Extension: 240)
Email: ethicscommitteemfc@gmail.com


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr K.H. Sellahewa
Consultant Physician
National Hospital of Sri Lanka, Premier Pacific Pinnacle, Apartment 6/9, No. 28, R.A. De Mel Mawatha, Colombo 4
+94 112502954


kolithah@eureka.lk

Contact Person for Public Queries

Dr K.H. Sellahewa
Consultant Physician
National Hospital of Sri Lanka, Premier Pacific Pinnacle, Apartment 6/9, No. 28, R.A. De Mel Mawatha, Colombo 4
+94 112502954


kolithah@eureka.lk


Primary study sponsor/organization

None





Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not Available


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results