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

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ClinicalTrials.gov Identifier: NCT01443247
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : September 29, 2011
Sponsor:
Information provided by (Responsible Party):
Dr. Deepak Thakur, Postgraduate Institute of Medical Education and Research

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

Condition or disease Intervention/treatment Phase
Dengue Fever Drug: anti-d Not Applicable

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 .


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Andi-d in Dengue Fever: a Pilot Study
Study Start Date : September 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Arm Intervention/treatment
Experimental: platelet support + anti-d 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
Other Name: winrho SDF

No Intervention: platelet support 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
Other Name: winrho SDF




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443247


Locations
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India
Post Graduate Institute of Medical Education and Research , Chandigarh , India
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: deepak thakur, md Post Graduate Institute of Medical Education and Research, Chandigarh

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Responsible Party: Dr. Deepak Thakur, junior resident, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01443247     History of Changes
Other Study ID Numbers: dengue fever pgimer trial
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: September 29, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Dengue
Fever
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral