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SLCTR Registration Number
SLCTR/2007/004
Date of Registration
The date of last modification
Aug 05, 2012
View original TRDS
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
None
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
Study 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
2006-08-31
Date of first enrollment
Date of study completion
Recruitment status
Complete
Funding source
None
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
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
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
Not Available
Protocol URL
Not Available
Results summary available
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
