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

Dengue Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443247
• Other study ID #: dengue fever pgimer trial
• Status: Completed
• Phase: N/A
• First received: September 25, 2011
• Last updated: September 28, 2011
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical ResearchUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dengue
• Dengue Fever
• Fever

Intervention

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

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research , Chandigarh , India	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes