Home » Trials » SLCTR/2007/004


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

SLCTR Registration Number

SLCTR/2007/004


Date of Registration

18 May 2007

The date of last modification

Nov 21, 2017


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


Phase


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

2005-11-01


Date of first enrollment


Date of study completion


Recruitment status

Complete


Funding source

None



State of Ethics Review Approval


Status


Date of Approval


Approval number


Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:


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


Study protocol available


Protocol version and date


Protocol URL


Results summary available


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results