Role of Andi-d in Dengue Fever: a Pilot Study

September 28, 2011 updated by: Dr. Deepak Thakur, Postgraduate Institute of Medical Education and Research
The purpose of this study is evaluate the role of anti-d in dengue fever.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Post Graduate Institute of Medical Education and Research , Chandigarh , India

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: platelet support + anti-d
Drug: anti-d
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
Other Names:
  • winrho SDF
NO_INTERVENTION: platelet support
Drug: anti-d
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
Other Names:
  • winrho SDF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 YEAR

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 YEAR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Principal Investigator: deepak thakur, md, Post Graduate Institute of Medical Education and Research, Chandigarh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

September 25, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (ESTIMATE)

September 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2011

Last Update Submitted That Met QC Criteria

September 28, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dengue fever pgimer trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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