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

Study Overview
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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 .

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

Conditions
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Dengue Fever

Intervention / Treatment
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* Drug: anti-d


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platelet support + anti-d<br> | Drug: anti-d<br>* 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<br>* Other names: winrho SDF;|
| No Intervention: platelet support<br> | Drug: anti-d<br>* 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<br>* Other names: winrho SDF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 1 YEAR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 1 YEAR |