Role of Andi-d in Dengue Fever: a Pilot Study
Primary Purpose
Dengue Fever
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
anti-d
Sponsored by
About this trial
This is an interventional treatment trial for Dengue Fever
Eligibility Criteria
inclusion criteria:
- fever and thrombocytopenia with/without bleeding manifestations
- dengue serology positive patients
- platelet count ≤ 20,000/mm3
- Rh positive patients
- willing to give written informed consent
exclusion criteria:
- dengue serology positive but platelet count > 20,000/mm3
- Rh negative patients
- pregnant females
Sites / Locations
- Post Graduate Institute of Medical Education and Research , Chandigarh , India
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
platelet support + anti-d
platelet support
Arm Description
Outcomes
Primary Outcome Measures
to see for the number of patients attaining a platelet count ≥ 50,000 /mm3 after 48 hours of administration of anti-d in the intervention arm
Secondary Outcome Measures
the difference in two study arms with respect to: total volume of platelet concentrate transfused , duration of hospital stay , & severity of haemorrhagic manifestations
Full Information
NCT ID
NCT01443247
First Posted
September 25, 2011
Last Updated
September 28, 2011
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT01443247
Brief Title
Role of Andi-d in Dengue Fever: a Pilot Study
Official Title
Role of Andi-d in Dengue Fever: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is evaluate the role of anti-d in dengue fever.
Detailed Description
This study was conducted in pgimer. Patients presenting with fever and thrombocytopenia in emergency medical opd / medicine opd were screened and all dengue serology positive patients were evaluated for enrolment into the study. We had proposed to enroll 30 patients with diagnosed dengue haemorrhagic fever. the diagnosis of the dengue fever was based upon the clinical history ,general physical examination and the lab tests : thrombocytopenia ( platelet count ≤ 20,000 ) ,and a positive dengue serology.
STUDY DESIGN : It was an open label inteventional study . one group of 15 patients ( intervention group ) received platelet support along with injection anti-d in a dose of 50 µg/kg (250IU/kg) intravenously while the other group of 15 ( control group) received platelet support only . a base line platelet count of all the participant of both the study groups was taken and then the level of platelets at 12 , 24 , 36 , and 48hr post treatment initiation was noted. The patients were followed till the time of discharge .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue Fever
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
platelet support + anti-d
Arm Type
Experimental
Arm Title
platelet support
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
anti-d
Other Intervention Name(s)
winrho SDF
Intervention Description
intervention group received injection anti-d in dose of 50 µg/kg (250IU/kg) along with platelet concentrate while control ( non intervention ) group received platelet support only
Primary Outcome Measure Information:
Title
to see for the number of patients attaining a platelet count ≥ 50,000 /mm3 after 48 hours of administration of anti-d in the intervention arm
Time Frame
1 YEAR
Secondary Outcome Measure Information:
Title
the difference in two study arms with respect to: total volume of platelet concentrate transfused , duration of hospital stay , & severity of haemorrhagic manifestations
Time Frame
1 YEAR
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
inclusion criteria:
fever and thrombocytopenia with/without bleeding manifestations
dengue serology positive patients
platelet count ≤ 20,000/mm3
Rh positive patients
willing to give written informed consent
exclusion criteria:
dengue serology positive but platelet count > 20,000/mm3
Rh negative patients
pregnant females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
deepak thakur, md
Organizational Affiliation
Post Graduate Institute of Medical Education and Research, Chandigarh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Post Graduate Institute of Medical Education and Research , Chandigarh , India
City
Chandigarh
ZIP/Postal Code
160012
Country
India
12. IPD Sharing Statement
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Role of Andi-d in Dengue Fever: a Pilot Study
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