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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The purpose of this study is evaluate the role of anti-d in dengue fever.

Detailed Summary:

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 .

Sponsor: Postgraduate Institute of Medical Education and Research

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: Postgraduate Institute of Medical Education and Research

Dates:
Date Received: September 25, 2011
Date Started: September 2010
Date Completion:
Last Updated: September 28, 2011
Last Verified: September 2011