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

NCT ID: NCT01443247

Last Updated: 2011-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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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 .

Conditions

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Dengue Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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platelet support + anti-d

Group Type EXPERIMENTAL

anti-d

Intervention Type DRUG

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

platelet support

Group Type NO_INTERVENTION

anti-d

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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winrho SDF

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Dr. Deepak Thakur

junior resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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deepak thakur, md

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

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

Chandigarh, Chandigarh, India

Site Status

Countries

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India

Other Identifiers

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dengue fever pgimer trial

Identifier Type: -

Identifier Source: org_study_id