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

Not Applicable

Completed

• Conditions: Dengue Fever
• Interventions: Drug: anti-d

• Registration Number: NCT01443247
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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 .

Study Timeline

• Study Start: 2010-09
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2011-09-25
• Study First Submitted QC: 2011-09-28
• Last Update Submitted: 2011-09-28
• Study First Posted: 2011-09-29
• Last Update Posted: 2011-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
platelet support + anti-d	anti-d	-
platelet support	anti-d	-

Primary Outcome Measures

Name	Time	Method
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	1 YEAR

Secondary Outcome Measures

Name	Time	Method
the difference in two study arms with respect to: total volume of platelet concentrate transfused , duration of hospital stay , & severity of haemorrhagic manifestations	1 YEAR

Trial Locations

Locations (1)

Post Graduate Institute of Medical Education and Research , Chandigarh , India; 🇮🇳 Chandigarh, India